Label: ACETAMINOPHEN PAIN RELIEVER,FEVER REDUCER 500 MG- acetaminophen tablet
- NDC Code(s): 45865-136-30
- Packager: Medsouce Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 51645-706
- 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 October 5, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purposes
- Uses
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Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) 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
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.
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.
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Directions
Do not take more than 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: ask a doctor.
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN PAIN RELIEVER,FEVER REDUCER 500 MG
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45865-136(NDC:51645-706) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score 2 pieces Shape ROUND (round flat faced beveled edge) Size 12mm Flavor Imprint Code GPI;A5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45865-136-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 10/01/2020 Labeler - Medsouce Pharmaceuticals (833685915) Establishment Name Address ID/FEI Business Operations Medsource Pharmaceuticals 833685915 repack(45865-136)
