MAPAP- acetaminophen tablet 
Aidarex Pharmaceuticals LLC

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.

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Drug Facts

Active Ingredients (in each tablet)

Acetaminophen 325 mg

Purposes

Pain reliever/fever reducer

Uses

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

Temporarily reduces fever.

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

Do not use

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

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.

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 warning: This product contains acetaminophen. Severe liver damage may occur ifadult 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 productDo not usewith any other drug 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 productAsk a doctor before use if the user has liver diseaseAsk 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. 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 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.

Liver warning: This product contains acetaminophen. Severe liver damage may occur ifadult 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 productDo not usewith any other drug 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 productAsk a doctor before use if the user has liver diseaseAsk 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 conditionIf 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.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

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

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.

Reorder No. 251706

Principal Display Panel  Tablets 325mg

 Mapap 325mg tablet

Mapap 325mg tablet

MAPAP 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33261-142(NDC:0904-1982)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (round flat faced beveled edge) Size10mm
FlavorImprint Code GPI;A325
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33261-142-00100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/21/2011
2NDC:33261-142-02120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/21/2011
3NDC:33261-142-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/21/2011
4NDC:33261-142-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/21/2011
5NDC:33261-142-9999 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/21/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/21/2011
Labeler - Aidarex Pharmaceuticals LLC (801503249)

Revised: 9/2012
Document Id: 186f6ced-01db-464f-99a5-31d586c6fb91
Set id: 36d77c8e-a575-4cb3-9eb1-57c2ac384a5c
Version: 8
Effective Time: 20120910
 
Aidarex Pharmaceuticals LLC