Label: ACETAMINOPHEN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68016-657-10 - Packager: Chain Drug Consortium,LLC
- 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 March 31, 2017
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- Official Label (Printer Friendly)
- Active ingredient
- 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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-657 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 HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) POVIDONE K30 (UNII: U725QWY32X) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code G552 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-657-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/25/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 02/25/2016 Labeler - Chain Drug Consortium,LLC (101668460)