Epinephrine injection is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which includes bees, wasps, hornets, yellow jackets and fire ants), and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media), and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.

Epinephrine injection is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.

Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria, or angioedema.

Epinephrine injection is intended for immediate administration as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.

• Injection: 0.3 mg (0.3 mg/0.3 mL) of clear and colorless solution in single-dose pre-filled auto-injector

None.

Due to the lack of randomized, controlled clinical trials of epinephrine for the treatment of anaphylaxis, the true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below.

Common adverse reactions to systemically administered epinephrine include anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache; and/or respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with hypertension or hyperthyroidism [see Warnings and Precautions (5.5)].

Cardiovascular Reactions

• Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs [see Warnings and Precautions (5.5) and Drug Interactions (7)].
• Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [see Warnings and Precautions (5.5)].
• Angina may occur in patients with coronary artery disease [see Warnings and Precautions (5.5)].
• Rare cases of stress cardiomyopathy have been reported in patients treated with epinephrine.

Reactions from Accidental Injection and/or Improper Technique

• Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area [see Warnings and Precautions (5.2)].
• Adverse reactions experienced as a result of accidental injections may include increased heart rate, local reactions including injection site pallor, coldness and hypoesthesia or injury at the injection site resulting in bruising, bleeding, discoloration, erythema or skeletal injury.
• Lacerations, bent needles, and embedded needles have been reported when epinephrine injection has been injected into the thigh of young children who are uncooperative and kick or move during an injection [see Warnings and Precautions (5.2)].
• Injection into the buttock has resulted in cases of gas gangrene [see Warnings and Precautions (5.2)].

Skin and Soft Tissue Infections

• Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection in the thigh [see Warnings and Precautions (5.3)].

Cardiac Glycosides, Diuretics, and Anti-arrhythmics

Patients who receive epinephrine while concomitantly taking cardiac glycosides, diuretics, or anti-arrhythmics should be observed carefully for the development of cardiac arrhythmias [see Warnings and Precautions (5.5)].

Antidepressants, Monoamine Oxidase Inhibitors, Levothyroxine, and Antihistamines

The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.

Beta-Adrenergic Blockers

The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta- adrenergic blocking drugs, such as propranolol.

Alpha-Adrenergic Blockers

The vasoconstricting and hypertensive effects of epinephrine are antagonized by alpha-adrenergic blocking drugs, such as phentolamine.

Ergot Alkaloids

Ergot alkaloids may also reverse the pressor effects of epinephrine.

Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation. Treatment consists of a rapidly acting vasodilators or alpha-adrenergic blocking drugs and/or respiratory support.

Epinephrine overdosage can also cause transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions may appear within one minute after injection and may be followed by multifocal ventricular tachycardia (prefibrillation rhythm). Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Treatment of arrhythmias consists of administration of a beta-adrenergic blocking drug such as propranolol.

Overdosage sometimes results in extreme pallor and coldness of the skin, metabolic acidosis, and kidney failure. Suitable corrective measures must be taken in such situations.

Epinephrine injection, USP 0.3 mg is an auto-injector and a combination product containing drug and device components.

Each epinephrine injection, USP 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP (0.3 mL) in a sterile solution.

Epinephrine injection, USP 0.3 mg contain 1.1 mL of epinephrine solution. 0.3 mL epinephrine solution is dispensed for epinephrine injection, USP 0.3 mg when activated. The solution remaining after activation is not available for future use and should be discarded.

Each 0.3 mL in epinephrine injection, USP 0.3 mg contains 0.3 mg epinephrine, 2.6 mg sodium chloride, not more than 1.5 mg chlorobutanol, 0.45 mg sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0.

Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure:

Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace epinephrine injection, USP if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles.

Thoroughly review the patient instructions and operation of epinephrine injection, USP with patients and caregivers prior to use [see Patient Counseling Information (17)].

Storage and Handling

Protect from light. Epinephrine is light sensitive and should be stored in the carrying-case provided to protect it from light. Store at room temperature (20°C to 25°C (68°F to 77°F)); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Do not refrigerate. Before using, check to make sure the solution in the auto-injector is clear and colorless. Replace the auto-injector if the solution is discolored (pinkish or brown color), cloudy, or contains particles.

Properly dispose of all used, unwanted, or expired epinephrine injection, USP.

See FDA-Approved Patient Labeling (Patient Information and Instructions for Use)

A healthcare provider should review the patient instructions and operation of epinephrine injection, in detail, with the patient or caregiver.

Epinephrine is essential for the treatment of anaphylaxis. Carefully instruct patients who are at risk of or with a history of severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens, as well as idiopathic and exercise-induced anaphylaxis, about the circumstances under which epinephrine should be used.

Administration

Instruct patients and/or caregivers in the appropriate use of epinephrine injection. Epinephrine injection should be injected into the middle of the outer thigh (through clothing if necessary).

Instruct caregivers to hold the leg of young children firmly in place and limit movement prior to and during injection. Lacerations, bent needles, and embedded needles have been reported when epinephrine injection has been injected into the thigh of young children who are uncooperative and kick during an injection [see Warnings and Precautions (5.2)].

Advise patients to seek immediate medical care in conjunction with administration of epinephrine injection.

Complete patient information, including dosage, directions for proper administration and precautions can be found inside each epinephrine injection carton. A printed label on the surface of epinephrine injection shows instructions for use and a diagram depicting the injection process.

Training

Instruct patients and/or caregivers to use the Trainer to familiarize themselves with the use of epinephrine injection in an allergic emergency. The Trainer may be used multiple times.

Adverse Reactions

Epinephrine may produce symptoms and signs that include an increase in heart rate, the sensation of a more forceful heartbeat, palpitations, sweating, nausea and vomiting, difficulty breathing, pallor, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These signs and symptoms usually subside rapidly, especially with rest, quiet, and recumbency. Patients with hypertension or hyperthyroidism may develop more severe or persistent effects, and patients with coronary artery disease could experience angina. Patients with diabetes may develop increased blood glucose levels following epinephrine administration. Patients with Parkinson’s disease may notice a temporary worsening of symptoms [see Warnings and Precautions (5.5)].

Accidental Injection

Advise patients to seek immediate medical care in the case of accidental injection. Since epinephrine is a strong vasoconstrictor when injected into the digits, hands or feet, treatment should be directed at vasodilation if there is such an accidental injection to these areas [see Warnings and Precautions (5.2)].

Serious Infections at the Injection Site

Rare cases of skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site [see Warnings and Precautions (5.3)].

Pregnancy and Breastfeeding

Inform patients that epinephrine injection has not been studied in pregnant women or breastfeeding mothers so the effects of epinephrine injection on pregnant women or breastfed infants are not known. Instruct patients to tell their healthcare provider if they are pregnant, become pregnant, or are thinking about becoming pregnant. Instruct patients to tell their healthcare provider if they plan to breastfeed their infant [see Use in Specific Populations (8.1, 8.2)].

Storage and Handling

Instruct patients to inspect the epinephrine solution visually through the viewing window periodically. Replace epinephrine injection, USP auto-injector if the epinephrine solution appears discolored (pinkish or brown), cloudy, or contains particles. Epinephrine is light sensitive, store in the outer case provided to protect it from light. Instruct patients that epinephrine injection, USP auto-injector must be properly disposed of once the blue caps have been removed or after use [see How Supplied/Storage and Handling (16)].

Complete patient information, including dosage, directions for proper administration and precautions are provided inside each epinephrine injection carton.

Manufactured by:

Hospira, Inc.

McPherson, KS 67460

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

© 2021 Amneal Pharmaceuticals LLC. All rights reserved.

For inquiries call 1-877-835-5472

EPINEPHRINE injection (ep-in-eph-rine),

for intramuscular or subcutaneous use

For allergic emergencies (anaphylaxis)

Read this Patient Information leaflet carefully before you use epinephrine injection, and each time you get a refill. There may be new information. You, your parent, caregiver, or others who may be in a position to administer epinephrine injection should know how to use it before you have an allergic emergency.

This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about epinephrine injection?

1. Epinephrine injection contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen within minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes. Symptoms of an anaphylaxis may include:

• trouble breathing
• wheezing
• hoarseness (changes in the way your voice sounds)
• hives (raised reddened rash that may itch)
• severe itching
• swelling of your face, lips, mouth, or tongue
• skin rash, redness, or swelling
• fast heartbeat
• weak pulse
• feeling very anxious
• confusion
• stomach pain
• losing control of urine or bowel movements (incontinence)
• diarrhea or stomach cramps
• dizziness, fainting, or “passing out” (unconsciousness)

2. Always carry your epinephrine injection with you because you may not know when anaphylaxis may happen. Talk to your healthcare provider if you need additional units to keep at work, school, or other locations. Tell your family members, caregivers, and others where you keep your epinephrine injection and how to use it before you need it. You may be unable to speak in an allergic emergency.

3. When you have an allergic emergency (anaphylaxis)

• Use epinephrine injection right away.
• Get emergency medical help right away. You may need further medical attention. You may need to use a second epinephrine injection if symptoms continue or recur. Only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode.

What is epinephrine injection?

• Epinephrine injection is a disposable, prefilled automatic injection device (auto-injector) used to treat life-threatening, allergic emergencies including anaphylaxis in people who are at risk for or have a history of serious allergic emergencies. Each device contains a single dose of epinephrine.
• Epinephrine injection is for immediate self (or caregiver) administration and does not take the place of emergency medical care. You should get emergency medical help right away after using epinephrine injection.
• Epinephrine injection is for people who have been prescribed this medicine by their healthcare provider.
• The epinephrine injection 0.3 mg auto-injector is for patients who weigh 66 pounds or more (30 kilograms or more).
• It is not known if epinephrine injection is safe and effective in children who weigh less than 33 pounds (15 kilograms).

Before using epinephrine injection, tell your healthcare provider about all your medical conditions, especially if you:

• have heart problems or high blood pressure
• have diabetes
• have thyroid problems
• have asthma
• have a history of depression
• have Parkinson's disease
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if epinephrine will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if epinephrine passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Tell your healthcare provider of all known allergies.

Especially tell your healthcare provider if you take certain asthma medicines.

Epinephrine injection and other medicines may affect each other, causing side effects. Epinephrine injection may affect the way other medicines work, and other medicines may affect how epinephrine injection works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Use your epinephrine injection for treatment of anaphylaxis as prescribed by your healthcare provider, regardless of your medical conditions or the medicine you take.

How should I use epinephrine injection?

• Each epinephrine injection contains only 1 dose of medicine.
• Epinephrine injection should only be injected into the middle of the outer thigh (upper leg). It can be injected through clothing, if needed.
• Read the Instructions for Use at the end of this Patient Information Leaflet for information about the right way to use epinephrine injection.
• Your healthcare provider will show you how to safely use epinephrine injection.
• Use epinephrine injection exactly as your healthcare provider tells you to use it. You may need to use a second epinephrine injection if symptoms continue or recur. Only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode.
• Caution: Never put your thumb, fingers, or hand over the red tip. Never press or push the red tip with your thumb, fingers, or hand. The needle comes out of the red tip. Accidental injection into finger, hands, or feet may cause a loss of blood flow to those areas. If this happens, go immediately to the nearest emergency room. Tell the healthcare provider where on your body you received the accidental injection.
• Your epinephrine injection comes packaged in a carton containing 1 or 2 epinephrine injection.
• You may request a separate Trainer, that comes packaged with instructions. Additional video instructions on the use of epinephrine injection are available from www.epinephrineautoinject.com. The epinephrine injection, USP auto-injector Trainer has a beige color. The beige epinephrine injection Trainer contains no medicine and no needle. Practice with your epinephrine injection Trainer before an allergic emergency happens to make sure you are able to safely use the real epinephrine injection in an emergency. Always carry your real epinephrine injection with you in case of an allergic emergency.
• Do not drop the carrying case or epinephrine injection. If the carrying case or epinephrine injection is dropped, check for damage and leakage. Throw away (dispose of) epinephrine injection and the carrying case, and replace if damage or leakage is noticed or suspected.

What are the possible side effects of epinephrine injection?

Epinephrine injection may cause serious side effects.

• Epinephrine injection should only be injected into the middle of your outer thigh (upper leg). Do not inject epinephrine injection into your:
  
  • veins
  • buttocks
  • fingers, toes, hands or feet.

If you accidentally inject epinephrine injection into any other part of your body, go to the nearest emergency room right away. Tell the healthcare provider where on your body you received the accidental injection.

• Rarely, people who use epinephrine injection may develop infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following at an injection site:
  
  • redness that does not go away
  • swelling
  • tenderness
  • the area feels warm to the touch

• Cuts on the skin, bent needles, and needles that remain in the skin after the injection, have happened in young children who do not cooperate and kick or move during an injection. If you inject a young child with epinephrine injection, hold their leg firmly in place before and during the injection to prevent injuries. Ask your healthcare provider to show you how to properly hold the leg of a young child during an injection.

• If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have more or longer lasting side effects when you use epinephrine injection. Talk to your healthcare provider about all your medical conditions.

Common side effects of epinephrine injection include:

• faster, irregular or “pounding” heartbeat
• sweating
• headache
• weakness
• shakiness
• paleness
• feelings of over excitement, nervousness, or anxiety
• dizziness
• nausea or vomiting
• breathing problems

These side effects may go away with rest. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of epinephrine injection. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store epinephrine injection?

• Store epinephrine injection at room temperature between 68°F to 77° F (20°C to 25° C).
• Protect from light.
• Do not expose to extreme heat or cold. For example, do not store in your vehicle’s glove box and do not store in the refrigerator or freezer.
• Examine the contents in the clear viewing window of your epinephrine injection periodically. The solution should be clear. If the solution is discolored (pinkish or brown), cloudy or contains solid particles, replace the unit.
• Always keep your epinephrine injection in the carrying case to protect it from damage. The carrying case is not waterproof.
• The two blue end caps help to prevent accidental injection. Do not remove the blue end caps until you are ready to use epinephrine injection.
• Your epinephrine injection has an expiration date. Replace it before the expiration date.
• Throw away (dispose of) expired, unwanted, or unused epinephrine injections in an FDA-cleared sharps disposal container. Do not throw away epinephrine injection in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  
  • Made of heavy-duty plastic,
  • Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • Upright and stable during use,
  • Leak-resistant, and
  • Properly labeled to warn of hazardous waste inside the container.
  When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal Visit the FDA’s website (https://www.fda.gov/drugs/safe-disposal-medicines/disposal- unused-medicines-what-you-should-know) for more information about how to throw away (dispose of) unused, unwanted or expired medicines.

Keep epinephrine injection and all medicines out of the reach of children.

General information about the safe and effective use of epinephrine injection:

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use epinephrine injection for a condition for which it was not prescribed. Do not give epinephrine injection to other people.

This Patient Information Leaflet summarizes the most important information about epinephrine injection. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about epinephrine injection that is written for health professionals.

What are the ingredients in epinephrine injection?

Active Ingredient: epinephrine

Inactive Ingredients: sodium chloride, chlorobutanol, sodium bisulfite, hydrochloric acid and sodium hydroxide, and water.

For more information and video instructions on the use of epinephrine injection go to www.epinephrineautoinject.com or call 1-877-835-5472.

Important Information

• The epinephrine injection 0.3 mg has a yellow colored label.
• The epinephrine injection Trainer has a beige color, and contains no medicine and no needle.
• Your epinephrine injection is designed to work through clothing.
• The two blue end caps on epinephrine injection help to prevent accidental injection of the device. Do not remove the blue end caps until you are ready to use it.
• Only inject into the middle of the outer thigh (upper leg). Never inject into any other part of the body.
• Never put your thumb, fingers, or your hand over the red tip. The needle comes out of the red tip.
• If an accidental injection happens, get medical help right away.
• Do not place patient information or any other foreign objects in carrier with the epinephrine injection, as this may prevent you from removing the auto-injector for use.

This Patient Information has been approved by the U.S. Food and Drug Administration
Rev. 02-2021-03

EPINEPHRINE injection (ep-in-eph-rine)

for intramuscular or subcutaneous use

For allergic emergencies (anaphylaxis)

Read this Instructions for Use carefully before you use epinephrine injection and each time you get a refill. There may be new information. Before you need to use your epinephrine injection, make sure your healthcare provider shows you the right way to use it. Parents, caregivers, and others who may be in a position to administer epinephrine injection should also understand how to use it well. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. If you have any questions, ask your healthcare provider.

Your epinephrine injection

Step 1. Prepare epinephrine injection for injection

• Remove epinephrine injection from its protective carrying case.
• Pull off blue end caps. You will now see a red tip. Grasp the epinephrine injection in your fist with the red tip pointing downward. See Figure A.

Note:

• The needle comes out of the red tip.
• To avoid an accidental injection, never put your thumb, fingers, or hand over the red tip. If an accidental injection happens, get medical help right away.

Step 2. Administer epinephrine injection

• If you are administering epinephrine injection to a young child, hold the leg firmly in place and limit movement prior to and while administering an injection.
• Put the red tip against the middle of the outer thigh (upper leg) at a 90° angle (perpendicular) to the thigh.
• Press down hard and hold firmly against the thigh for approximately 10 seconds to deliver the medicine. See Figure B.

• Only inject into the middle of the outer thigh. Do not inject into any other part of the body.
• Remove epinephrine injection from the thigh.
• Massage the area for 10 seconds.
• Check the red tip. The injection is complete and you have received the correct dose of the medicine if you see the needle sticking out of the red tip. If you do not see the needle repeat Step 2.

Step 3. Get emergency medical help right away. You may need further medical attention. You may need to use a second epinephrine injection if symptoms continue or recur.

Step 4. After use Disposal

Carefully cover the needle with the carrying case.

• Lay the labeled half of the carrying case cover down on a flat surface. Use one hand to carefully slide the end of the epinephrine injection needle first, into the labeled carrying case cover. See Figure C.

• After the needle is inside the labeled cover, push the unlabeled half of the carrying case cover firmly over the non-needle end of the epinephrine injection . See Figure D.

• Take your used epinephrine injection with you when you go to see a healthcare provider.
• Tell the healthcare provider that you have received an injection of epinephrine. Show the healthcare provider where you received the injection.
• Give your used epinephrine injection to the healthcare provider for inspection and proper disposal.
• Ask for a refill, if needed.

Note:

• Epinephrine injection is a single-use injectable device that delivers a fixed dose of epinephrine. Epinephrine injection cannot be reused. Do not attempt to reuse epinephrine injection after the device has been activated. It is normal for most of the medicine to remain in the auto-injector after the dose is injected. The correct dose has been administered if you see the needle sticking out of the red tip.
• A separate epinephrine injection Trainer is available. The epinephrine injection Trainer has a beige color. The beige epinephrine injection Trainer contains no medicine and no needle. Practice with your epinephrine injection Trainer, but always carry your real epinephrine injection in case of an allergic emergency.
• If you will be administering epinephrine injection to a young child, ask your healthcare provider to show you how to properly hold the leg in place while administering a dose.
• Do not try to take epinephrine injection.

For more information and video instructions on the use of epinephrine injection, go to www.epinephrineautoinject.com or call 1-877-835-5472.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

© 2021 Amneal Pharmaceuticals LLC. All rights reserved.

Manufactured by:
Hospira, Inc.
McPherson, KS 67460

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Revised 02-2021-03

Albuterol Sulfate Inhalation Aerosol HFA with Dose Indicator

FOR ORAL INHALATION ONLY

Prescribing Information

The active component of Albuterol Sulfate Inhalation Aerosol is albuterol sulfate, USP racemic α 1 [( tert-Butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diol sulfate (2:1)(salt), a relatively selective beta 2-adrenergic bronchodilator having the following chemical structure:

Albuterol sulfate is the official generic name in the United States. The World Health Organization recommended name for the drug is salbutamol sulfate. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C13H21NO3)2•H2SO4. Albuterol sulfate is a white to off-white crystalline solid. It is soluble in water and slightly soluble in ethanol. Albuterol Sulfate Inhalation Aerosol is a pressurized metered-dose aerosol unit for oral inhalation. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane), ethanol, and oleic acid.

Each actuation delivers 120 mcg albuterol sulfate, USP from the valve and 108 mcg albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Each canister provides 200 inhalations. It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four “test sprays” into the air, away from the face.

This product does not contain chlorofluorocarbons (CFCs) as the propellant.

Albuterol Sulfate Inhalation Aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

Albuterol Sulfate Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any other Albuterol Sulfate Inhalation Aerosol components.

1. Paradoxical Bronchospasm: Inhaled albuterol sulfate can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, Albuterol Sulfate Inhalation Aerosol should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.
2. Deterioration of Asthma: Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of Albuterol Sulfate Inhalation Aerosol than usual, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
3. Use of Anti-inflammatory Agents: The use of beta-adrenergic-agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids, to the therapeutic regimen.

4. Cardiovascular Effects: Albuterol Sulfate Inhalation Aerosol, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of Albuterol Sulfate Inhalation Aerosol at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, Albuterol Sulfate Inhalation Aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

5. Do Not Exceed Recommended Dose: Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.
6. Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.

Adverse reaction information concerning Albuterol Sulfate Inhalation Aerosol is derived from a 12-week, double-blind, double-dummy study which compared Albuterol Sulfate Inhalation Aerosol, a CFC 11/12 propelled albuterol inhaler, and an HFA-134a placebo inhaler in 565 asthmatic patients. The following table lists the incidence of all adverse events (whether considered by the investigator drug related or unrelated to drug) from this study which occurred at a rate of 3% or greater in the Albuterol Sulfate Inhalation Aerosol treatment group and more frequently in the Albuterol Sulfate Inhalation Aerosol treatment group than in the placebo group. Overall, the incidence and nature of the adverse reactions reported for Albuterol Sulfate Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler were comparable.

Adverse events reported by less than 3% of the patients receiving Albuterol Sulfate Inhalation Aerosol, and by a greater proportion of Albuterol Sulfate Inhalation Aerosol patients than placebo patients, which have the potential to be related to Albuterol Sulfate Inhalation Aerosol include: dysphonia, increased sweating, dry mouth, chest pain, edema, rigors, ataxia, leg cramps, hyperkinesia, eructation, flatulence, tinnitus, diabetes mellitus, anxiety, depression, somnolence, rash. Palpitation and dizziness have also been observed with Albuterol Sulfate Inhalation Aerosol.

Adverse events reported in a 4-week pediatric clinical trial comparing Albuterol Sulfate Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler occurred at a low incidence rate and were similar to those seen in the adult trials.

In small, cumulative dose studies, tremor, nervousness, and headache appeared to be dose related.

Rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema have been reported after the use of inhaled albuterol. In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, insomnia, headache, metabolic acidosis, and drying or irritation of the oropharynx.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia.

Hypokalemia may also occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of Albuterol Sulfate Inhalation Aerosol. Treatment consists of discontinuation of Albuterol Sulfate Inhalation Aerosol together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Albuterol Sulfate Inhalation Aerosol.

The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 6800 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 3200 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis). In mature rats, the subcutaneous median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 3000 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 1400 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis). In young rats, the subcutaneous median lethal dose is approximately 2000 mg/kg (approximately 14,000 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 6400 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis). The inhalation median lethal dose has not been determined in animals.

For treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, the usual dosage for adults and children 4 years of age and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient. Each actuation of Albuterol Sulfate Inhalation Aerosol delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) from the mouthpiece. It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four “test sprays” into the air, away from the face.

Albuterol Sulfate Inhalation Aerosol is supplied as a pressurized aluminum canister, with an attached dose indicator, a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations (NDC 0781-7296-85).

Rx only. Store between 15° to 25°C (59° to 77°F). Store the inhaler with the mouthpiece down. For best results, canister should be at room temperature before use.

SHAKE WELL BEFORE USING.

The yellow actuator supplied with Albuterol Sulfate Inhalation Aerosol should not be used with any other product canisters, and actuator from other products should not be used with a Albuterol Sulfate Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations and when the dose indicator display window shows zero, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.

WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.

Albuterol Sulfate Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Distributed by:
Sandoz Inc.
Princeton, NJ 08540

Copyright © 1996, 2011, 2012, 2017, 2018, 2020
All rights reserved. The trademarks depicted in this piece are owned by their respective companies.

Revised: 12/2020

INSTRUCTIONS FOR USE
Albuterol Sulfate (al-BYOO-ter-ole)
Inhalation Aerosol with Dose Indicator

Read this Instructions for Use before you start using Albuterol Sulfate Inhalation Aerosol and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment. Your doctor should show you how your child should use Albuterol Sulfate Inhalation Aerosol.

Important Information:

• Albuterol Sulfate Inhalation Aerosol is for oral inhalation use only.
• Take Albuterol Sulfate Inhalation Aerosol exactly as your doctor tells you to.

Albuterol Sulfate Inhalation Aerosol comes as a canister with a dose indicator. The dose indicator is located on the top of the canister that fits into an actuator (See Figure A). The dose indicator display window will show you how many puffs of medicine you have left. A puff of medicine is released each time you press the center of the dose indicator.

• Do not use the Albuterol Sulfate Inhalation Aerosol actuator with a canister of medicine from any other inhaler.
• Do not use the Albuterol Sulfate Inhalation Aerosol canister with an actuator from any other inhaler.

Figure A

Before you use Albuterol Sulfate Inhalation Aerosol for the first time make sure that the pointer on the dose indicator is pointing to the right of the “200” inhalation mark in the dose indicator display window (See Figure A) .

Each canister of Albuterol Sulfate Inhalation Aerosol contains 200 puffs of medicine. This does not include the sprays of medicine used for priming your inhaler.

• The dose indicator display window will continue to move after every 10 puffs.
• The number in the dose indicator display window will continue to change after every 20 puffs.
• The color in the dose indicator display window will change to red, as shown in the shaded area, when there are only 20 puffs of medicine left in your inhaler (See Figure B) . This is when you need to refill your prescription or ask your doctor if you need another prescription for Albuterol Sulfate Inhalation Aerosol.

Figure B

Before using your Albuterol Sulfate Inhalation Aerosol for the first time, you should prime your inhaler. If you do not use your Albuterol Sulfate Inhalation Aerosol for more than 2 weeks, you should re-prime it before use.

• Remove the cap from the mouthpiece (See Figure C). Check inside the mouthpiece for objects before use.
• Make sure the canister is fully inserted into the actuator.
• Hold the inhaler in an upright position away from your face and shake the inhaler well.
• Press down fully on the center of the dose indicator to release a spray of medicine. You may hear a soft click from the dose indicator as it counts down during use.
• Repeat the priming step 3 more times to release a total of 4 sprays of medicine. Shake the inhaler well before each priming spray.
• After the 4 priming sprays, the dose indicator should be pointing to 200. There are now 200 puffs of medicine left in the canister.
• Your inhaler is now ready to use.

Using your Albuterol Sulfate Inhalation Aerosol inhaler:

Step 1: Shake the inhaler well before each use. Remove the cap from the mouthpiece (See Figure C). Check inside the mouthpiece for objects before use. Make sure the canister is fully inserted into the actuator.

Figure C

Step 2: Breathe out as fully as you comfortably can through your mouth. Hold the inhaler in the upright position with the mouthpiece pointing towards you and place the mouthpiece fully into the mouth (See Figure D). Close your lips around the mouthpiece.

Figure D

Step 3: While breathing in deeply and slowly, press down on the center of the dose indicator with your index finger until the canister stops moving in the actuator and a puff of medicine has been released (See Figure D). Then stop pressing the dose indicator.

Step 4: Hold your breath as long as you comfortably can, up to 10 seconds. Remove the inhaler from your mouth, and then breathe out.

Step 5: If your doctor has prescribed additional puffs of Albuterol Sulfate Inhalation Aerosol, wait 1 minute then shake the inhaler well. Repeat steps 3 through 5 in the section “ Using your Albuterol Sulfate Inhalation Aerosol inhaler”.

Step 6: Replace the cap right away after use.

Cleaning your Albuterol Sulfate Inhalation Aerosol inhaler:

It is very important that you keep the mouthpiece clean so that medicine will not build up and block the spray through the mouthpiece. Clean the mouthpiece 1 time each week or if your mouthpiece becomes blocked (See Figure F).

Step 1: Remove the canister from the actuator and take the cap off the mouthpiece. Do not clean the metal canister or let it get wet.

Step 2: Wash the mouthpiece through the top and bottom with warm running water for 30 seconds (See Figure E).

Figure E

Step 3: Shake off as much water from the mouthpiece as you can.

Step 4: Look in the mouthpiece to make sure any medicine buildup has been completely washed away. If the mouthpiece is blocked with buildup, little to no medicine will come out of the mouthpiece (See Figure F). If there is any buildup, repeat Steps 2 through 4 in the section “ Cleaning your Albuterol Sulfate Inhalation Aerosol inhaler”.

Figure F

Step 5: Let the mouthpiece air-dry such as overnight ( Figure G). Do not put the canister back into the actuator if it is still wet.

Figure G

Step 6: When the mouthpiece is dry, put the canister back in the actuator and put the cap on the mouthpiece.

Note: If you need to use your Albuterol Sulfate Inhalation Aerosol inhaler before it is completely dry, put the canister back in the actuator and shake the inhaler well. Press down on the center of the dose indicator 2 times to release a total of 2 sprays into the air, away from your face. Take your dose as prescribed then clean and air-dry your inhaler as described in the section “ Cleaning your Albuterol Sulfate Inhalation Aerosol inhaler”.

How should I store Albuterol Sulfate Inhalation Aerosol?

• Store Albuterol Sulfate Inhalation Aerosol at room temperature between 59°F and 77°F (15°C and 25°C).
• Store with the mouthpiece down.
• Avoid exposing Albuterol Sulfate Inhalation Aerosol to extreme heat and cold.
• Do not puncture or burn the canister.
• Keep your Albuterol Sulfate Inhalation Aerosol inhaler and all medicines out of the reach of children.

Developed and Manufactured by: 
Kindeva Drug Delivery L.P.
Northridge, CA 91324, USA

Distributed by:
Sandoz Inc.
Princeton, NJ 08540

Copyright © 1996, 2011, 2012, 2017, 2018, 2020All rights reserved.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 12/2020

NITROGLYCERIN TABLETS

These highlights do not include all the information needed to use NITROGLYCERIN SUBLINGUAL TABLETS safely and effectively. See full prescribing information for NITROGLYCERIN SUBLINGUAL TABLETS

NITROGLYCERIN sublingual tablets, for oral use
Initial U.S. Approval: 1981

FULL PRESCRIBING INFORMATION

Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.

Administer one tablet under the tongue or in the buccal pouch at the first sign of an acute anginal attack. Allow tablet to dissolve without swallowing. One additional tablet may be administered every 5 minutes until relief is obtained. No more than three tablets are recommended within a 15-minute period. If the pain persists after a total of 3 tablets in a 15-minute period, or if the pain is different than is typically experienced, seek prompt medical attention.

Nitroglycerin sublingual tablets may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack.

For patients with xerostomia, a small sip of water prior to placing the tablet under the tongue may help maintain mucosal hydration and aid dissolution of the tablet.

Administer nitroglycerin sublingual tablets at rest, preferably in the sitting position.

Nitroglycerin Sublingual Tablets, USP are supplied as white to off-white, round, flat-faced tablets in three strengths:

0.3 mg (Debossed with “1” on one side and “C” on the other)
0.4 mg (Debossed with “2” on one side and “C” on the other)
0.6 mg (Debossed with “3” on one side and “C” on the other)

• Tolerance: Excessive use may lead to tolerance. (5.1)
• Hypotension: Severe hypotension may occur. (5.2)

The following adverse reactions are discussed in more detail elsewhere in the label:

Hypotension [see Warnings and Precautions (5.2)]
Headache [see Warnings and Precautions (5.4)]
Hypersensitivity [see Contraindications (4.4)]

Vertigo, dizziness, weakness, palpitation, and other manifestations of postural hypotension may develop occasionally, particularly in erect, immobile patients. Marked sensitivity to the hypotensive effects of nitrates (manifested by nausea, vomiting, weakness, diaphoresis, pallor, and collapse) may occur at therapeutic doses. Syncope due to nitrate vasodilatation has been reported.

Flushing, drug rash, and exfoliative dermatitis have been reported in patients receiving nitrate therapy.

Ergotamine: increased bioavailability of ergotamine. Avoid concomitant use. (7.2)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 10/2021

Nitroglycerin Sublingual Tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin; as well as calcium stearate, croscarmellose sodium, silica dimethyl silylate and lactose monohydrate.

Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is:

Molecular weight: 227.09 g/mol

Nitroglycerin Sublingual Tablets, USP are supplied as white to off white, round, flat-faced tablets in 3 strengths (0.3 mg, 0.4 mg, and 0.6 mg) in bottles.

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Nitroglycerin should be kept in the original glass container and must be tightly capped after each use to prevent loss of tablet potency.

Advise the patient to read the FDA-approved patient labeling (Patient Information).

This product's label may have been updated. For full prescribing information, please visit www.glenmarkpharma-us.com.

Manufactured by:

Glenmark Pharmaceuticals Limited

India

Manufactured for:

Glenmark Pharmaceuticals Inc., USA

Mahwah, NJ 07430

Questions? 1 (888) 721-7115

www.glenmarkpharma-us.com

October 2021

Nitroglycerin (nahy-truh-glis-er-in)
Sublingual Tablets, USP

Read this information carefully before you start nitroglycerin sublingual tablets and each time you refill your prescription. There may be new information. This information does not replace talking with your doctor. If you have any questions about nitroglycerin sublingual tablets, ask your doctor. Your doctor will know if nitroglycerin sublingual tablets are right for you.

What are Nitroglycerin Sublingual Tablets?

Nitroglycerin sublingual tablets are type of medicine known as an organic nitrate and is a vasodilating agent. It is used to treat a type of chest pain called angina.

What is Angina?

Angina is a pain or discomfort that keeps coming back when part of your heart does not get enough blood. Angina feels like a pressing or squeezing pain, usually in your chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck, jaws, or back. Nitroglycerin sublingual tablets can relieve this pain.

Who should not use Nitroglycerin Sublingual Tablets?

Do not use nitroglycerin sublingual tablets if you are allergic to organic nitrates (like the active ingredient in nitroglycerin).

You should not take nitroglycerin sublingual tablets if you have the following conditions:

• very recent heart attack
• severe anemia
• increased pressure in the head

Do not take nitroglycerin sublingual tablets with drugs for erectile dysfunction, like VIAGRA® (sildenafil citrate), CIALIS® (tadalafil), or LEVITRA® (vardenafil hydrochloride), as this may lead to extreme lowering of your blood pressure.

Do not take nitroglycerin sublingual tablets if you take medicines called guanylate cyclase stimulators which include riociguat, a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension.

What should I tell my doctor before taking Nitroglycerin Sublingual Tablets?

Before using nitroglycerin sublingual tablets, tell your doctor if:

• You are taking any medicines that are used to treat angina, heart failure, or an irregular heartbeat.
• You are taking any medicines that reduce blood pressure.
• You are taking any diuretics (water pills).
• You are taking medicines that can cause dry mouth such as tricyclic antidepressants (e.g. amitriptyline, desipramine, doxepin), anticholinergic drugs, or any antimuscarinic drugs (e.g. atropine).
• You are taking ergotamine or similar drugs for migraine headaches.
• You are taking aspirin.
• You are taking any medicines for erectile dysfunction.
• You are pregnant or plan to become pregnant.
• You are breastfeeding.

How should I take Nitroglycerin Sublingual Tablets?

• Do not chew, crush, or swallow nitroglycerin sublingual tablets.
• You should sit down when taking nitroglycerin sublingual tablets and use caution when you stand up. This eliminates the possibility of falling due to lightheadedness or dizziness.
• One tablet should be dissolved under the tongue or in the oral cavity at the first sign of chest pain.
• The dose may be repeated approximately every 5 minutes, until the chest pain is relieved.
• If the pain persists after a total of 3 tablets in a 15-minute period, or is different than you typically experience, call your doctor or seek emergency help.
• Nitroglycerin sublingual tablets may be used 5 to 10 minutes prior to activities that might cause chest pain.
• You may feel a burning or tingling sensation in your mouth when you take nitroglycerin sublingual tablets.

What should I avoid while taking Nitroglycerin Sublingual Tablets?

• Do not breastfeed. It is not known if nitroglycerin will pass through your milk.
• Do not consume alcohol while taking nitroglycerin sublingual tablets, as this can lower your blood pressure.
• Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first.

What are the possible side effects of Nitroglycerin Sublingual Tablets?

Nitroglycerin sublingual tablets may cause the following side effects:

• headache
• vertigo (a major symptom of balance disorder)
• dizziness
• weakness
• heart palpitations (unusual awareness of the heartbeat)
• low blood pressure upon rising from a seated position
• nausea and vomiting
• sweating
• paleness
• fainting
• flushing (warm or red condition of your skin)
• other skin reactions that may be severe

Tell your doctor if you are concerned about any side effects you experience. These are not all the possible side effects of nitroglycerin sublingual tablets. For a complete list, ask your doctor or pharmacist.

How do I store Nitroglycerin Sublingual Tablets?

Nitroglycerin sublingual tablets should be kept in the original glass container and tightly capped after each use to prevent loss of tablet potency.

Store nitroglycerin sublingual tablets at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

General advice about Nitroglycerin Sublingual Tablets

Sometimes doctors will prescribe a medicine for a condition that is not included in the patient information leaflets. Only use nitroglycerin sublingual tablets the way your doctor told you to. Do not give nitroglycerin sublingual tablets to other people, even if they have the same symptoms you have. They may harm them.

You can ask your pharmacist or doctor for information about nitroglycerin sublingual tablets, or you can call Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115.

Trademarks are the property of their respective owners.

Manufactured by:

Glenmark Pharmaceuticals Limited

India

Manufactured for:

Glenmark Pharmaceuticals Inc., USA

Mahwah, NJ 07430

Questions? 1 (888) 721-7115

www.glenmarkpharma-us.com

October 2021

DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, USP

Rx only

Diphenhydramine Hydrochloride Injection is a sterile, nonpyrogenic solution for intravenous or deep intramuscular use as an antihistaminic agent. Each mL contains diphenhydramine hydrochloride 50 mg and benzethonium chloride 100 mcg in Water for Injection. pH 4.0-6.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment.

The chemical name of diphenhydramine hydrochloride is 2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride. The structural formula is as follows:

C17H21NO • HCl MW 291.82

Diphenhydramine hydrochloride occurs as a white crystalline powder and is freely soluble in water and alcohol.

Diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells.

Diphenhydramine hydrochloride in the injectable form has a rapid onset of action. Diphenhydramine is widely distributed throughout the body, including the CNS. A portion of the drug is excreted unchanged in the urine, while the rest is metabolized via the liver. Detailed information on the pharmacokinetics of Diphenhydramine Hydrochloride Injection is not available.

Diphenhydramine Hydrochloride Injection is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is impractical:

Antihistamines should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy or bladder-neck obstruction.

Local necrosis has been associated with the use of subcutaneous or intradermal use of intravenous diphenhydramine.

The most frequent adverse reactions are italicized.

Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in pediatric patients. Atropine-like signs and symptoms, dry mouth; fixed, dilated pupils; flushing, and gastrointestinal symptoms may also occur.

Stimulants should not be used.

Vasopressors may be used to treat hypotension.

THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY.

Diphenhydramine Hydrochloride Injection is indicated when the oral form is impractical.

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.

Diphenhydramine Hydrochloride Injection, USP 50 mg/mL

BAYER GENUINE ASPIRIN TABLETS

Drug Facts

Aspirin 325 mg (NSAID)1

1nonsteroidal anti-inflammatory drug

Pain reliever/fever reducer

• temporarily relieves minor aches and pains due to:
• headache
• muscle pain
• toothache
• menstrual pain
• colds
• minor pain of arthritis

• temporarily reduces fever

Reye's syndrome:
Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert:
Aspirin may cause a severe allergic reaction which may include:

• hives
• facial swelling
• asthma (wheezing)
• shock

Stomach bleeding warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Do not use

• if you are allergic to aspirin or any other pain reliever/fever reducer
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have asthma

Ask a doctor or pharmacist before use if you are taking a prescription drug for

• gout
• diabetes
• arthritis

Stop use and ask doctor if

• an allergic reaction occurs. Seek medical help right away.
• you experience any of the following signs of stomach bleeding:
• feel faint
• vomit blood
• have bloody or black stools
• have stomach pain that does not get better

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• ringing in the ears or a loss of hearing occurs

If pregnant or breast-feeding, ask a health professional before use.

It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

• drink a full glass of water with each dose
• adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
• children under 12 years: consult a doctor

• save carton for full directions and warnings
• store at room temperature

corn starch, hypromellose, powdered cellulose, triacetin

1-800-331-4536 (Mon-Fri 9AM-5PM EST)

This product is repackaged by: Select Corporation
1433 Wainwright Way, Carrollton, TX 75007
877-244-4400 M - F 9am - 5 pm, from a product manufactured by Bayer.

Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981

15 g Fast acting Carbohydrates per Serving

Raises low blood sugar and boosts energy

Fat Free
Gluten Free
Sodium Free

ORANGE NATURALLY & ARTIFICIALLY FLAVORED

DO NOT USE IF PROTECTIVE SEAL IS BROKEN OR MISSING

QUESTIONS? Call 1-800-803-6025

INGREDIENTS: DEXTROSE (D-GLUCOSE), MALTODEXTRIN, CITRIC ACID, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLUOSE, NATURAL & ARTIFICIAL ORANGE FLAVOR, ASCORBIC ACID, YELLOW #6.

Chew desired amount of glucose.

Store at room temperature. Do not refrigerate or freeze. Do not expose to excessive heat or moisture.

Distributed by McKesson
6555, State Highway 161,
Las Colinas, TX 75039

TRUEplus is a trademark of Trivida Health, Inc.

healthmart.com

KIT CONTAINS:

EPINEPHRINE AUTO-INJECT (0.3 mg) – 1 no.
ALBUTEROL SULFATE HFA INHALER (90 mcg) – 1 no.
NITROGLYCERIN SUBLINGUAL TABLETS (0.4 mg) – 1 bottle (25 tablets)
DIPHENHYDRAMINE HCl INJECTION SOLUTION (50 mg/mL) – 1 vial
ASPIRIN TABLETS (325 mg) – 1 Pouch (2 nos).
GLUCOSE TABLETS – 1 bottle (10 nos).
BD PLASTIPAK 3 mL SYRINGE 25GX1-1/2" – 1 no.

BESTDENTAL.COM