Label: POWERFUL PAIN MEDICINE- acetaminophen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 10956-762-01, 10956-762-25, 10956-762-50 - Packager: REESE PHARMACEUTICAL CO.
- 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 20, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
LIVER WARNING This product contains acetaminophen.
severe liver damage may occur if adult takes more than 6 doses in 24 hours
which is the maximum daily amount.
child takes more than 5 doses in 24 hours
which is the maximum daily amount.
taken with other drugs containing acetaminophen.
adult has 3 or more alcoholic drinks everyday while using this product. -
DOSAGE & ADMINISTRATION
Directions
do not use more than directed
adults and children 12 years of age and older take 1 caplet
every 4 hours as needed.
do not exceed 6 doses in a 24 hour period or as directed by a doctor.
children under 12 years of age;
do not use this adult product in children under 12 years of age
this will provide more than the recommended dose ( overdose ) of
non aspirin and could cause health problems. - INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
POWERFUL PAIN MEDICINE
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10956-762 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 650 mg Inactive Ingredients Ingredient Name Strength STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape OVAL (tablet) Size 19mm Flavor Imprint Code 78 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10956-762-50 50 in 1 BOTTLE, PLASTIC 2 NDC:10956-762-01 1 in 1 CARTON 2 NDC:10956-762-25 25 in 1 BOTTLE, PLASTIC 2 NDC:10956-762-01 1 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 06/30/1990 Labeler - REESE PHARMACEUTICAL CO. (004172052) Registrant - REESE PHARMACEUTICAL CO. (004172052) Establishment Name Address ID/FEI Business Operations REESE PHARMACEUTICAL CO. 004172052 repack, relabel Establishment Name Address ID/FEI Business Operations CONTRACT PHARMACAL 057795122 manufacture
