DIPHEN- benzocaine, benzalkonium chloride, lidocaine hydrochloride, hydrocortisone, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, calcium carbonate, ibuprofen, loratadine, acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, diphenhydramine hydrochloride, potassium chloride, magnesium oxide, meclizine hydrochloride, and bismuth subsalicylate 
Remedy Pack LLC

----------

Diphen

REMEDY PACK

Burn Cream

Drug Facts

INGREDIENTS

Active ingredients

Benzalkonium Chloride 0.13%, Lidocaine HCl 0.5%

Purpose

Topical antiseptic, Topicall analgesic

USES

First aid to help prevent infection in minor cuts, scrapes and burns.

For the temporary relief of pain and itching associated with:

WARNING

For external use only.

Do not use

  • in the eyes
  • over large areas of the body or on deep puncture wounds, animal bites, or serious burns
  • in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask doctor if

  • the condition gets worse
  • condition clears up and recurs within a few days
  • condition persists for more than 7 days

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Adults and children 2 years and over:

OTHER INFORMATION

INACTIVE INGREDIENTS

decolorized aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

Triple Antibiotic

Drug Facts

INGREDIENTS

Active Ingredient (in each gram)

Bacitracin zinc (400 units), Neomycin sulfate 5 mg (equivalent to 3.5 mg of Neomycin), Polymyxin-B sulfate 5000 units

Purposes

First aid antibiotics

USES

First aid to help prevent infection in:

WARNING

Do not use

  • in the eyes
  • over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor

Ask a doctor before use

in case of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

the condition persists or gets worse a rash or other allergic reaction develops

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
may be covered with a sterile bandage

OTHER INFORMATION

INACTIVE INGREDIENTS

mineral oil, white petrolatum

Hydrocortisone Cream

Drug Facts

INGREDIENTS

Active Ingredient (in each gram)

Hydrocortisone 1.0%

Purpose

Anti-Itch

USES

Other uses of this product should only be under the advice and supervision of a doctor.

WARNING

  • do not use for the treatment of diaper rash.

  • Keep out of reach of children.
  • If swallowed, get medical help or consult a poison control center right away.

DIRECTIONS

Adult and children (2 years and over): apply to affected not more than 3 to 4 times daily

Children under 2 years: Consult a doctor.

OTHER INFORMATION

INACTIVE INGREDIENTS

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white Wax.

Oral Pain Relief Gel

Drug Facts

INGREDIENTS

Active ingredients

Benzocaine 20%

Purpose

Oral Anesthetic

USES

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

METHEMOGLOBINEMIA WARNING

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood.

This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

ALLERGY ALERT

do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other " caine" anesthetics.

Do not use

For more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly.

  • for teething
  • in children under 2 years of age

When using this product

avoid contact with eyes. If it occurs, flush with water.

Do not exceed recommended dosage.

  • If more than used for pain is accidently swallowed, get medical help or contact a Poison Control Center right away.

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

  • Keep out of reach of children.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

Flavoring, PEG 3350, PEG 400, sodium sacchrin, water.

May contain blue #1, green #3, green #5 , red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as color additive.

Alcalak

Drug Facts

INGREDIENTS

Active ingredient (in each tablet)

Calcium Carbonate 420mg

Purpose

Antacid

INACTIVE INGREDIENTS1

aspartame1, croscarmellose sodium1, gum acacia1, magnesium stearate, maltodextrin, mineral oil1, mint flavor, sorbitol1, sucrose1


1
may contain

USES

For the relief of the following symptoms associated with

WARNING

Do not use

  • the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician, or take more than 19 tablets in a 24 hour period.

Ask a doctor or pharmacist before use if you are

  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if

  • symptoms last more than 2 weeks

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

DIRECTIONS

Adults and children: (12 years and older) Chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a physician. Do not exceed 19 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

OTHER INFORMATION

Cold Relief

Drug Facts

INGREDIENTS

Active ingredient (in each tablet): Acetaminophen 325mgPurpose: Pain reliever/ fever reducer
Active ingredient (in each tablet): Dextromethorphan Hydrobromide 15mgPurpose: Cough suppressant
Active ingredient (in each tablet): Guaifenesin 200mgPurpose: Expectorant
Active ingredient (in each tablet): Phenylephrine HCl 5mgPurpose: Nasal decongestant

INACTIVE INGREDIENTS*

maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

USES

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

Temporarily reduces fever.

WARNING

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you have ever had an allergic reaction to this product or any of the ingredients.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

When using this product

  • do not use more than directed

Stop use and ask a doctor if

  • new symptoms occur
  • redness or swelling is present
  • pain or nasal congestion gets worse or lasts for more than 7 days
  • fever gets worse or lasts for more than 3 days
  • you get nervous, dizzy or sleepless
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DIRECTIONS

Adults and children: (12 years and older) Take 2 tablets with water every 6- 8 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

OTHER INFORMATION

Medi-Meclizine

Drug Facts

INGREDIENTS

Active ingredient (in each tablet)

Meclizine Hydrochloride 25mg

Purpose

Antiemetic

INACTIVE INGREDIENTS*

anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow #10, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

USES

For the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.

For the reduction of fever.

WARNING

Do not use

  • for children under 12 years of age unless directed by a doctor
  • for frequent or prolonged use except under the advice of a doctor

Ask a doctor before use if you have

  • breathing problems such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland if you are
  • taking sedatives or tranquilizers

When using this product

  • drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages while taking this product
  • use caution when driving a motor vehicle or operating machinery

Do not exceed recommended dosage.

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Adults and children: (12 years and older) 1 to 2 tablets once daily or as directed by a doctor. Do not exceed 2 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

OTHER INFORMATION

I-Prin

Drug Facts

INGREDIENTS

Active ingredient (in each tablet)

Ibuprofen (NSAID2) 200mg


2
nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

INACTIVE INGREDIENTS3

carnauba wax3, corn starch, hypromellose3, iron oxide red, lactose3, magnesium stearate3, microcrystalline cellulose3, polydextrose3, polyethylene glycol, polyvinyl alcohol3, povidone (K-30)3, silicon dioxide, sodium starch glycolate, stearic acid, talc3, titanium dioxide


3
may contain

USES

Temporarily relieves minor aches and pains associated with

Temporarily reduces fever.

WARNING

Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

  • hives
  • skin reddening
  • facial swelling
  • rash
  • asthma (wheezing)
  • blisters
  • shock

If an allergic reaction occurs, stop use and seek medical help right away.

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

Heart attack or stroke warning: NSAIDS, except aspirin, increase the risk of heart attack, heart failure, and stroke.

These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/ fever reducer
  • right before or after heart surgery

Ask a doctor before use if

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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, kidney disease, asthma or had a stroke
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor's care for any serious condition
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

  • 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
  • you have symptoms of heart problems or stroke
    -
    chest pain
    -
    trouble breathing
    -
    weakness in one part or side of body
    -
    slurred speech
    -
    leg swelling
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new or unexpected symptoms occur

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Adults and children: (12 years and older) Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

OTHER INFORMATION

Diphen

Drug Facts

INGREDIENTS

Active ingredient (in each tablet)

Diphenhydramine HCl 25mg

Purpose

Antihistamine

INACTIVE INGREDIENTS4

carnauba wax4, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate4, hypromellose, lactose4, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate4, titanium dioxide


4
may contain

USES

Active ingredients

Diphenhydramine HCl 25mg

Purpose

Antihistamine

Inactive Ingredients5

carnauba wax5, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate5, hypromellose, lactose5, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate5, titanium dioxide


5
may contain

WARNING

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one that is used on skin

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • avoid alcohol beverages
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center immediately.

DIRECTIONS

Adults and children: (12 years and older) Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

OTHER INFORMATION

Extra Strength APAP

Drug Facts

INGREDIENTS

Active ingredient (in each tablet)

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer

INACTIVE INGREDIENTS6

corn starch, hypromellose, maltodextrin6, microcrystalline cellulose6, polyethylene glycol, povidone6, pregelatinized starch6, sodium starch glycolate6, stearic acid, titanium dioxide6


6
may contain

USES

For the temporary relief of minor aches and pains associated with

For the reduction of fever.

WARNING

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 8 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert

Acetaminophen may cause severe skin reactions.

Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if you have

  • liver disease

Ask a doctor or pharmacist before use if

  • you are taking the blood thinning drug warfarin

Stop using and ask a doctor if

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse
  • redness or swelling is present

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

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DIRECTIONS

Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

OTHER INFORMATION

Loradamed

Drug Facts

INGREDIENTS

Active ingredient (in each tablet)

Loratadine 10mg

Purpose

Antihistamine

INACTIVE INGREDIENTS*

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

USES

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

WARNING

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

  • an allergic reaction to this product occurs. Seek medical help right away.

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DIRECTIONS

Adults and children: (12 years and older) Take 1 tablet daily; not more than 1 tablet in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

Consumers with liver or kidney disease: Ask a doctor before using.

OTHER INFORMATION

Medi-Lyte

Drug Facts

INFORMATION

Serving Size: 2 tablets

Servings Per Packet: 1

OTHER INGREDIENTS

microcrystalline cellulose, silicon dioxide, stearic acid, magnesium stearate

Amount Per Serving% Daily Value
Calcium (from 27.0 mg calcium carbonate) 10.8 mg1.06%
Potassium (from 80 mg potassium chloride) 40mg1.15%
Magnesium (from 20 mg magnesium oxide) 12 mg3.0%
Carbohydrates 6 mg>1%
Calories 1.5>1%
Protein0%
Fat0%

USES

Nutritional support for the following symptoms due to excessive loss of perspiration

*This statement has not been evaluated by the Food and Drug administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

WARNING

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Adults and children: (12 years and older)

Children under 12 years:

OTHER INFORMATION

Diotame

Drug Facts

INGREDIENTS

Active ingredient (in each tablet)

Bismuth Subsalicylate 262mg (each tablet contains 102mg salicylate)

Purpose

Upset stomach reliever/antidiarrheal

INACTIVE INGREDIENTS*

acacia gum, aspartame, calcium carbonate, D&C red #27, dextrates, flavoring, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide

USES

Temporarily relieves

WARNING

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

Contains salicylate. Do not take if you are:

  • allergic to salicylates (including aspirin)
  • taking other salicylate products

Do not use if you have

  • bloody or black stool
  • an ulcer
  • a bleeding problem

Ask a doctor before use if you have

  • fever
  • mucus in the stool

Ask a doctor or pharmacist if you are taking any drug for

  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Stop use and ask a doctor if

  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days

When using this product a temporary and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena.

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

Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately.

DIRECTIONS

Adults and children: (12 years and older) Chew 2 tablets every 1/2 to 1 hour or 4 tablets every hour as needed.

Children under 12 years: Do not give to children under 12 years of age.

OTHER INFORMATION

PRINCIPAL DISPLAY PANEL - Kit Carton

REMEDY PACK

DRUG FACTS

www.theremedypack.com

PRINCIPAL DISPLAY PANEL - Kit Carton
DIPHEN 
benzocaine, benzalkonium chloride, lidocaine hydrochloride, hydrocortisone, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, calcium carbonate, ibuprofen, loratadine, acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, diphenhydramine hydrochloride, potassium chloride, magnesium oxide, meclizine hydrochloride, and bismuth subsalicylate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82652-021
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82652-021-011 in 1 CARTON05/10/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 PACKET 3 g
Part 22 PACKET 1.8 g
Part 34 PACKET 3.6 g
Part 48 PACKET 4 g
Part 52 PACKET
Part 64 PACKET
Part 74 PACKET
Part 84 PACKET
Part 94 PACKET
Part 102 PACKET
Part 113 PACKET
Part 124 PACKET
Part 133 PACKET
Part 1 of 13
PAIN RELIEF 
benzocaine liquid
Product Information
Item Code (Source)NDC:82652-033(NDC:61010-8100)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
polyethylene glycol 400 (UNII: B697894SGQ)  
polyethylene glycol 3350 (UNII: G2M7P15E5P)  
peppermint oil (UNII: AV092KU4JH)  
saccharin sodium (UNII: SB8ZUX40TY)  
sorbic acid (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82652-033-010.75 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/01/2010
Part 2 of 13
BURN 
benzalkonium chloride and lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:82652-029(NDC:47682-940)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 mg  in 1 g
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Methylparaben (UNII: A2I8C7HI9T)  
Mineral Oil (UNII: T5L8T28FGP)  
Paraffin (UNII: I9O0E3H2ZE)  
Propylparaben (UNII: Z8IX2SC1OH)  
Water (UNII: 059QF0KO0R)  
White Petrolatum (UNII: B6E5W8RQJ4)  
White Wax (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82652-029-010.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34808/29/2017
Part 3 of 13
HYDROCORTISONE 
hydrocortisone cream
Product Information
Item Code (Source)NDC:82652-027(NDC:47682-923)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (Hydrocortisone - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Methylparaben (UNII: A2I8C7HI9T)  
Mineral Oil (UNII: T5L8T28FGP)  
Paraffin (UNII: I9O0E3H2ZE)  
Petrolatum (UNII: 4T6H12BN9U)  
Propylparaben (UNII: Z8IX2SC1OH)  
Water (UNII: 059QF0KO0R)  
White Wax (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82652-027-010.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34806/01/2021
Part 4 of 13
TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
Product Information
Item Code (Source)NDC:82652-028(NDC:47682-932)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin400 [USP'U]  in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin3.5 mg  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
Polyethylene Glycol 400 (UNII: B697894SGQ)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
FD&C Green No. 3 (UNII: 3P3ONR6O1S)  
D&C Green No. 5 (UNII: 8J6RDU8L9X)  
FD&C Red No. 3 (UNII: PN2ZH5LOQY)  
D&C Red No. 28 (UNII: 767IP0Y5NH)  
FD&C Red No. 40 (UNII: WZB9127XOA)  
FD&C Yellow No. 5 (UNII: I753WB2F1M)  
FD&C Yellow No. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82652-028-010.5 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B06/04/2018
Part 5 of 13
ALCALAK 
calcium carbonate tablet, chewable
Product Information
Item Code (Source)NDC:82652-023(NDC:47682-201)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Calcium Carbonate (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) Calcium Carbonate420 mg
Inactive Ingredients
Ingredient NameStrength
Aspartame (UNII: Z0H242BBR1)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
Acacia (UNII: 5C5403N26O)  
Magnesium Stearate (UNII: 70097M6I30)  
Maltodextrin (UNII: 7CVR7L4A2D)  
Mineral Oil (UNII: T5L8T28FGP)  
Sorbitol (UNII: 506T60A25R)  
Sucrose (UNII: C151H8M554)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code AZ;036
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82652-023-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33106/15/2014
Part 6 of 13
I-PRIN 
ibuprofen tablet, film coated
Product Information
Item Code (Source)NDC:82652-024(NDC:47682-683)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
Carnauba Wax (UNII: R12CBM0EIZ)  
Starch, Corn (UNII: O8232NY3SJ)  
Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Lactose, Unspecified Form (UNII: J2B2A4N98G)  
Magnesium Stearate (UNII: 70097M6I30)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Polydextrose (UNII: VH2XOU12IE)  
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
Polyvinyl Alcohol, Unspecified (UNII: 532B59J990)  
Povidone K30 (UNII: U725QWY32X)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Talc (UNII: 7SEV7J4R1U)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44;291
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82652-024-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07501002/01/2021
Part 7 of 13
LORADAMED 
loratadine tablet, film coated
Product Information
Item Code (Source)NDC:82652-022(NDC:47682-203)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN) Loratadine10 mg
Inactive Ingredients
Ingredient NameStrength
Starch, Corn (UNII: O8232NY3SJ)  
Lactose Monohydrate (UNII: EWQ57Q8I5X)  
Magnesium Stearate (UNII: 70097M6I30)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code RX;526
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82652-022-011 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613412/30/2008
Part 8 of 13
COLD RELIEF 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet
Product Information
Item Code (Source)NDC:82652-032(NDC:47682-725)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide15 mg
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin200 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
Maltodextrin (UNII: 7CVR7L4A2D)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Povidone, Unspecified (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize12mm
FlavorImprint Code FR;12
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82652-032-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/01/2021
Part 9 of 13
DIPHEN 
diphenhydramine hydrochloride tablet, film coated
Product Information
Item Code (Source)NDC:82652-031(NDC:47682-166)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
Carnauba Wax (UNII: R12CBM0EIZ)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
D&C Red No. 27 (UNII: 2LRS185U6K)  
Anhydrous Dibasic Calcium Phosphate (UNII: L11K75P92J)  
Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
Lactose, Unspecified Form (UNII: J2B2A4N98G)  
Magnesium Stearate (UNII: 70097M6I30)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code 048;D
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82652-031-011 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/01/2021
Part 10 of 13
MEDI-LYTE 
calcium carbonate, potassium chloride, and magnesium oxide tablet
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Calcium Carbonate (UNII: H0G9379FGK) (Calcium Cation - UNII:2M83C4R6ZB, Carbonate Ion - UNII:7UJQ5OPE7D) Calcium Carbonate27 mg
Potassium Chloride (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) Potassium Chloride80 mg
Magnesium Oxide (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) Magnesium Oxide20 mg
Inactive Ingredients
Ingredient NameStrength
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Magnesium Stearate (UNII: 70097M6I30)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize9mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT05/10/2022
Part 11 of 13
MEDI-MECLIZINE 
meclizine hydrochloride tablet
Product Information
Item Code (Source)NDC:82652-030(NDC:47682-481)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Meclizine Hydrochloride (UNII: HDP7W44CIO) (Meclizine - UNII:3L5TQ84570) Meclizine Hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
Anhydrous Lactose (UNII: 3SY5LH9PMK)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Starch, Corn (UNII: O8232NY3SJ)  
D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
Magnesium Stearate (UNII: 70097M6I30)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize9mm
FlavorImprint Code 44;403
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82652-030-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33612/14/2020
Part 12 of 13
EXTRA STRENGTH APAP 
acetaminophen tablet, film coated
Product Information
Item Code (Source)NDC:82652-025(NDC:47682-043)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen500 mg
Inactive Ingredients
Ingredient NameStrength
Starch, Corn (UNII: O8232NY3SJ)  
Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
Maltodextrin (UNII: 7CVR7L4A2D)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize12mm
FlavorImprint Code FR;33
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82652-025-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34302/01/2021
Part 13 of 13
DIOTAME 
bismuth subsalicylate tablet, chewable
Product Information
Item Code (Source)NDC:82652-026(NDC:47682-210)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bismuth Subsalicylate (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) Bismuth Subsalicylate262 mg
Inactive Ingredients
Ingredient NameStrength
Acacia (UNII: 5C5403N26O)  
Aspartame (UNII: Z0H242BBR1)  
Calcium Carbonate (UNII: H0G9379FGK)  
D&C Red No. 27 (UNII: 2LRS185U6K)  
Dextrates (UNII: G263MI44RU)  
Magnesium Stearate (UNII: 70097M6I30)  
Maltodextrin (UNII: 7CVR7L4A2D)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize16mm
FlavorPEPPERMINTImprint Code RH;046
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82652-026-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33504/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613405/10/2022
Labeler - Remedy Pack LLC (101454060)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc874965262MANUFACTURE(82652-021)
Establishment
NameAddressID/FEIBusiness Operations
Remedy Pack LLC101454060RELABEL(82652-033, 82652-029, 82652-027, 82652-028, 82652-023, 82652-024, 82652-022, 82652-032, 82652-031, 82652-030, 82652-025, 82652-026) , REPACK(82652-033, 82652-029, 82652-027, 82652-028, 82652-023, 82652-024, 82652-022, 82652-032, 82652-031, 82652-030, 82652-025, 82652-026)
Establishment
NameAddressID/FEIBusiness Operations
Allegiant Health079501930MANUFACTURE(82652-021)
Establishment
NameAddressID/FEIBusiness Operations
LNK International Inc.966812120MANUFACTURE(82652-021)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Limited918609236MANUFACTURE(82652-021)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories051565745MANUFACTURE(82652-021)

Revised: 7/2022
Document Id: 7e3354b4-6202-423f-bb85-88c0ac01958d
Set id: 5d185f23-8af6-4e36-b514-5662986520a5
Version: 1
Effective Time: 20220711
 
Remedy Pack LLC