Active Ingredient
(in each capsule)
Acetaminophen 500 mg
Mapap
FDA Label NDC 53808-0822
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by State Of Florida Doh Central Pharmacy for the product Mapap (NDC 53808-0822). 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 active ingredient, purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor 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
Purposes
Analgesic, Antipyretic
Uses
- temporarily relieves minor aches and pains due to
- the common cold
- headache
- toothache
- muscular aches
- backache
- minor pain of arthritis
- premenstrual and menstrual cramps
- temporarily reduces 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
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 Before Use If You Are
taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts more than 3 days
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.
Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Inactive Ingredients
FD&C Blue #1, FD&C Red #40, Gelatin, Polyvinylpyrrolidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid and Titanium Dioxide.
*Major Extra Strength Mapap is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®.
Distributed by:
MAJOR PHARMACEUTICALS
Livonia, MI 48150 USA
This Product was Repackaged By:
State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States
They are supplied by State of Florida DOH Central Pharmacy as follows:
| NDC | Strength | Quantity/Form | Color | Source Prod. Code |
| 53808-0822-1 | 500 mg | 30 Capsules in a Blister Pack | RED | 0904-1987 |
Package Label.Principal Display Panel
* Please review the disclaimer below.
