Extra Strength Mapap
FDA Label NDC 52959-338

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H.j. Harkins Company, Inc. for the product Extra Strength Mapap (NDC 52959-338). 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 (in each caplet), 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

Active Ingredient (In Each Caplet)

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Uses

for the temporary relief of minor aches and pains due to:

  • Headache
  • Muscular aches
  • Backache
  • Minor pain of arthritis
  • The common cold
  • Toothache
  • 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 caplets 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 drug containing acetaminophen (prescription or non prescription). 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 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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Overdosage

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In the 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

Adults and children 12 years and over:

  • take 2 caplets every 4 to 6 hours while symptoms last
  • do not take more than 8 caplets 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 acetaminophen and may cause liver damage.

Other Information

  • Do not use if imprinted safety seal under cap is broken or missing.
  • store at room temperature

Inactive Ingredients

Hypromellose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Questions?

Adverse Drug Events call (800) 616-2471

Repacked by:

H.J. Harkins Company, Inc.

513 Sandydale Drive

Nipomo, CA 93444

Principal Display Panel Of Extra Strength Mapap 500 Mg Caplets

NDC 0904-1983-60

MAJOR®
See New Warnings Information
Extra Strength
Mapap

ASPIRIN FREE
ACETAMINOPHEN

STRONG PAIN &
FEVER RELIEF

CAPLETS

Compare to active ingredient in Extra Strength Tylenol® Caplets*

*This product is not manufactured or distributed by McNeil Consumer Products Co., owner of the registered trademark Tylenol®.

100 Caplets
500 mg. Each
NDC 0904-1983-24

MAJOR®

EXTRA STRENGTH
Mapap
See New Warnings Information
ASPIRIN FREE
ACETAMINOPHEN

STRONG PAIN & FEVER RELIEF

CAPLETS

Compare to the active ingredients in Extra Strength Tylenol® Caplets*

See New Warning Information

24 Caplets
500 mg. Each

Repacked by:

H.J. Harkins Company, Inc.

Nipomo, CA 93444

*This product is not manufactured or distributed by McNeil Consumer Products Co., owner of registered trademark Tylenol®

* Please review the disclaimer below.