Label: ACETAMINOPHEN capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 55315-989-10, 55315-989-50 - Packager: FREDS, INC
- Category: HUMAN OTC DRUG LABEL
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 July 17, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Purpose
- Uses
- Liver warning
- Allergy alert
- Do not use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Keep out of the reach of children
- Overdose warning
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Directions
■ do not take more than directed (see overdose warning)
adults and children 12 years and over
■ take 2 caplets every 6 hours while symptoms last
■ do not take more than 6 caplets in 24 hours, unless directed by a doctor
■ do not use for more than 10 days unless directed by a doctor
children under 12 years
ask a doctor - Other information
- Inactive ingredients
- Questions or comments?
- EXTRA STRENGTH PAIN RELIEVER ACETAMINOPHEN, USP 500 mg Pain Reliever/Fever Reducer 100 CAPLETS** ** Capsule-Shaped Tablets 500 mg each
- EXTRA STRENGTH PAIN RELIEVER ACETAMINOPHEN, USP 500 mg Pain Reliever/Fever Reducer 500 CAPLETS 500 mg each
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-989 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 POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) HYPROMELLOSES (UNII: 3NXW29V3WO) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color white Score no score Shape CAPSULE Size 18mm Flavor Imprint Code G551 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55315-989-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/17/2017 2 NDC:55315-989-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/17/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 08/17/2017 Labeler - FREDS, INC (005866116)