Label: MAPAP- acetaminophen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 33261-142-00, 33261-142-02, 33261-142-20, 33261-142-30, view more33261-142-99 - Packager: Aidarex Pharmaceuticals LLC
- This is a repackaged label.
- Source NDC Code(s): 0904-1982
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated September 10, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients (in each tablet)
- Purposes
- Uses
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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 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 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.
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
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.
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
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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
- Questions?
- Principal Display Panel Tablets 325mg
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INGREDIENTS AND APPEARANCE
MAPAP
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33261-142(NDC:0904-1982) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE Score no score Shape ROUND (round flat faced beveled edge) Size 10mm Flavor Imprint Code GPI;A325 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33261-142-00 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/21/2011 2 NDC:33261-142-02 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/21/2011 3 NDC:33261-142-20 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/21/2011 4 NDC:33261-142-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/21/2011 5 NDC:33261-142-99 99 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/21/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 04/21/2011 Labeler - Aidarex Pharmaceuticals LLC (801503249)
