Your browser does not support JavaScript! EXTRA STRENGTH MAPAP (ACETAMINOPHEN) TABLET [MAJOR PHARMACEUTICALS]
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RxNorm Names

EXTRA STRENGTH MAPAP (acetaminophen) tablet
[Major Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

Active Ingredient (in each tablet)

Acetaminophen 500 mg

Purposes

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.

The maximum daily dose of this product is 6 tablets (3,000mg) in 24 hours.  Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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 the directed (see overdose warning)

Adults and children 12 years and over:

  • Take 2 tablets every 6 hours while symptoms last.
  • Do not take more than 6 tablets in 24 hours unless directed by a doctor
  • 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

  • Store at room temperature

Inactive ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Questions?

To Report Adverse Drug Event call (800) 616-2471

Dist. By MAJOR PHARMACEUTICALS

31778 Enterprise Drive. Livonia, MI 48150

Tamper Evident

 Do not use if sealed blister units are broken or damaged.

PRINCIPAL DISPLAY PANEL EXTRA STRENGTH MAPAP 500MG

EXTRA STRENGTH MAPAP 500MG

 

EXTRA STRENGTH MAPAP 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0904-1988
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONES 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUND (round flat faced beveled edge) Size12mm
FlavorImprint Code GPI;A5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-1988-61100 in 1 BOX, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34305/04/2011
Labeler - Major Pharmaceuticals (191427277)

Revised: 8/2012
 
Major Pharmaceuticals

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