NDC | 49999-131-30, 49999-131-60, 49999-131-90 |
Set ID | 51c44fdf-9b6f-4ded-b755-d18a7d2dd4dc |
Category | HUMAN OTC DRUG LABEL |
Packager | Lake Erie Medical DBA Quality Care Products LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- 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
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.
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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
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INGREDIENTS AND APPEARANCE
MAPAP
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49999-131(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:49999-131-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/21/2011 2 NDC:49999-131-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/21/2011 06/01/2014 3 NDC:49999-131-90 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/21/2011 06/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/21/2011 Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758) Establishment Name Address ID/FEI Business Operations Lake Erie Medical DBA Quality Care Products LLC 831276758 repack(49999-131)