Drug Facts
Active Ingredient (in each capsule)
Acetaminophen 500 mg
Mapap Capsule
FDA Label NDC 0904-1987
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Mapap (NDC 0904-1987). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Purposes
Analgesic, Antipyretic
Uses
temporarily relieves minor aches and pains associated with the
- common cold
- headache
- toothache
- muscular aches
- backache
- arthritis
- menstrual cramps
- reduction of fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 capsules 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
- skin reddening
- blisters
- rash. If a skin reaction occurs, stop use and seek medical help right away.
Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
Do Not Use
- with any other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
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 Use And Ask A Doctor If
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Overdose Warning:
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Directions
Do not take more than directed (see overdose warning).
adults and children 12 years and over:
- take 2 capsules every 4 to 6 hours while symptoms last
- Do not take more than 8 capsules in 24 hours
- Do not take for more than 10 days unless directed by a doctor
children under 12 years:
Do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of pain reliever and may cause liver damage
Other Information
- store at room temperature, USP
- use by expiration date on package
- do not use if capsule band or imprinted safety seal under cap is broken or missing
Inactive Ingredients
FD&C Blue #1, FD&C Red #40, Gelatin, Polyvinylpyrrolidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid and Titanium Dioxide
Questions?
Adverse Drug Event Call: (800) 616-2471
Other
*Major® Extra Strength Mapap® Capsules are not manufactured or distributed by McNeil Consumer Products, Co. distributor of Tylenol® Extra Strength Capsules.
Distributed by: MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152
M-29 Rev 03/17 4050-03-17
Package Label.Principal Display Panel
Major
NDC 0904-1987-60
EXTRA STRENGTH
Mapap
Acetaminophen 500 mg Each
CAPSULES SAFETY SEALED FOR YOUR PROTECTION
SEE NEW WARNINGS INFORMATION
ASPIRIN FREE
Safe, Fast Pain Relief Analgesic
Compare to Active Ingredient of
Tylenol® Extra Strength Capsules*
100 CAPSULES
* Please review the disclaimer below.
