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Mapap by Major Pharmaceuticals

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-1982

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 tablet)

Acetaminophen 325 mg

Purposes

Pain reliever/fever reducer

Aspirin-Free 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

adult takes more than 12 tablets in 24 hours,which is the maximum daily amount
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen 
adult has 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 the user has

liver disease.

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

Stop use and ask a doctor if
Pain gets worse or lasts more than 10 days in adults and children
Pain gets worse or lasts more than 5 days in children under 12 years
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 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

  AGE

  DOSE

  Adults and children 12 years and over

  

Take 2 tablets every 4 to 6 hours while symptoms last
Do not take more than 12 tablets in 24 hours

  Children 6 to 11 years

  

Take 1 tablet every 4 to 6 hours while symptoms last
 Do not take more than 5 tablets in 24 hours

  Children under 6 years

Do not use adult Regular Strength products in children under 6 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 or comments?

Adverse Drug Event call (800) 616-2471

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

LHC54731216

Distributed by:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152 USA

Principal Display Panel Unit Dose Label

MAJOR® PHARMACEUTICALS

NDC 0904-1982-61

Unit Dose

See New Warnings Information

MAPAP TABLETS

(Regular Strength Acetaminophen)

325 mg 100 TABLETS

Principal Display Panel

MAJOR®

NDC 0904-1982-80

THIS LARGE SIZE PACKAGE FOR DISPENSING PURPOSE ONLY

Compare to the active ingredient in regular strength Tylenol® Tablets*

Mapap

Regular Strength

TABLETS

Aspirin-Free Pain Reliever/Fever Reducer

See New Warnings Information

1000 ACETAMINOPHEN TABLETS

325 mg. EACH

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

MAPAP 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-1982
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K12 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
STARCH, CORN 
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (round flat faced beveled edge) Size10mm
FlavorImprint CodeGPI;A325
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-1982-591 BOTTLE, PLASTIC in 1 BOX
1100 TABLET in 1 BOTTLE, PLASTIC
2NDC:0904-1982-61100 BLISTER PACK in 1 CARTON
21 TABLET in 1 BLISTER PACK
3NDC:0904-1982-5150 TABLET in 1 BOTTLE, PLASTIC
4NDC:0904-1982-60100 TABLET in 1 BOTTLE, PLASTIC
5NDC:0904-1982-801000 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/21/2011
Labeler - Major Pharmaceuticals (191427277)
Registrant - GEMINI PHARMACEUTICALS INC. (055942270)
Establishment
NameAddressID/FEIOperations
GEMINI PHARMACEUTICALS INC.055942270MANUFACTURE(0904-1982)

Revised: 08/2017
 
Major Pharmaceuticals

See Also

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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