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Extra Strength Mapap by H.J. Harkins Company, Inc.

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: H.J. Harkins Company, Inc.
NDC Code: 52959-338

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 Facts

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.

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 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 CapletsNDC 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®
EXTRA STRENGTH MAPAP  
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-338(NDC:0904-1983)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
POLYETHYLENE GLYCOL 
POVIDONE 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULE (Biconvex) Size17mm
FlavorImprint CodeGPI;A5
Contains    
Packaging
#Item CodePackage Description
1NDC:52959-338-00100 TABLET, FILM COATED (CAPSULE) in 1 BOTTLE
2NDC:52959-338-1010 TABLET, FILM COATED (CAPSULE) in 1 BOTTLE
3NDC:52959-338-1212 TABLET, FILM COATED (CAPSULE) in 1 BOTTLE
4NDC:52959-338-2020 TABLET, FILM COATED (CAPSULE) in 1 BOTTLE
5NDC:52959-338-2424 TABLET, FILM COATED (CAPSULE) in 1 BOTTLE
6NDC:52959-338-3030 TABLET, FILM COATED (CAPSULE) in 1 BOTTLE
7NDC:52959-338-4040 TABLET, FILM COATED (CAPSULE) in 1 BOTTLE
8NDC:52959-338-5050 TABLET, FILM COATED (CAPSULE) in 1 BOTTLE
9NDC:52959-338-6060 TABLET, FILM COATED (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34305/04/2011
Labeler - H.J. Harkins Company, Inc. (147681894)
Registrant - H.J. Harkins Company, Inc. (147681894)
Establishment
NameAddressID/FEIOperations
H.J. Harkins Company, Inc.147681894repack, relabel

Revised: 01/2012
 
H.J. Harkins Company, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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