Label: MEDI FIRST PAIN RELIEF- acetaminophen, aspirin, salicylamide and caffeine tablet
MEDI FIRST PLUS PAIN ZAPPER- acetaminophen, aspirin, salicylamide and caffeine tablet
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NDC Code(s):
47682-811-13,
47682-811-33,
47682-811-48,
47682-811-99, view more47682-911-33, 47682-911-48
- Packager: Unifirst First Aid Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 23, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
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 and Salicylamide may cause a severe allergic reaction which may include:
■ hives ■ facial swelling ■ asthma (wheezing) ■ shock
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening ■ blisters ■ rash
If a skin or allergic reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen 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
Stomach bleeding warning: This product contains nonsteroidal anti-inflammatory drugs (NSAIDs), 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
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine- containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.
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 pain for more than 10 days unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
- with any other pain releiver/fever reducer
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems (such as heartburn, upset stomach or stomach pain)
- you have heart disease, liver cirrhosis, or kidney disease
- you have asthma or high blood pressure
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are taking a prescription drug for
- anticoagulation
- diabetes
- gout
- arthritis
Ask a doctor or pharmacist before use if you have
- liver disease
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
- symptoms do not improve
- pain or fever gets worse
- ringing in the ears or hearing loss occurs
- new symptoms appear
If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use aspirin or salicyamide 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.
Keep out of reach of children.
Overdose warning:
Taking more than the recommended dose (overdose) may cause liver damage.
In case of 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.
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- QUESTIONS
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Medi-First Pain Relief Label
100 Tablets
(50 x 2)
Medi-First ®
Pain Relief extra strength
Fast Acting Advanced Formula
Pull to Open
Aches, & Fever • Acetaminophen 110 mg Aspirin (NSAID) 162 mg
Pain Reliever • Salicylamide (NSAID) 152 mg
Pain Reliever Aid • Caffeine 32.4 mg
This Package is for Households without Young Children.
Tamper Evident Unit Dose Packets
- Medi-First Plus Pain Zapper Label
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INGREDIENTS AND APPEARANCE
MEDI FIRST PAIN RELIEF
acetaminophen, aspirin, salicylamide and caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-811 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 110 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 162 mg SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE 152 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 32.4 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color orange (orange) Score no score Shape ROUND (ROUND) Size 11mm Flavor Imprint Code FR;2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-811-33 50 in 1 BOX 12/30/2008 03/01/2024 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-811-48 125 in 1 BOX 12/30/2008 03/01/2024 2 2 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:47682-811-13 250 in 1 BOX 12/30/2008 03/01/2024 3 NDC:47682-811-99 2 in 1 PACKET; Type 0: Not a Combination Product 4 NDC:47682-811-99 2 in 1 PACKET; Type 0: Not a Combination Product 12/30/2008 03/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 12/30/2008 03/01/2024 MEDI FIRST PLUS PAIN ZAPPER
acetaminophen, aspirin, salicylamide and caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-911 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 110 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 162 mg SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE 152 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 32.4 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color orange (orange) Score no score Shape ROUND (ROUND) Size 11mm Flavor Imprint Code FR;2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-911-33 50 in 1 BOX 12/30/2008 03/01/2024 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-911-48 125 in 1 BOX 12/30/2008 03/01/2024 2 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 12/30/2008 03/01/2024 Labeler - Unifirst First Aid Corporation (832947092)