Label: ACETAMINOPHEN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68016-655-10 - Packager: Chain Drug Consortium, LLC
- 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 March 31, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
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Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if
■ adult takes more than 4,000 mg of acetaminophen in 24 hours
■ 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 every day while using this product
- Do not use
- Ask a doctor before use if
- Ask a doctor or pharmacist before use if
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Keep out of 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 tablets every 4 to 6 hours while symptoms last
■ do not take more than 10 tablets in 24 hours
■ do not take more than 10 days unless directed by a doctor
children 6-11 years
■ take 1 tablet every 4 to 6 hours while symptoms last
■ do not take more than 5 tablets in 24 hours
■ do not take more than 5 days unless directed by a doctor
children under 6 years
ask a doctor
- 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:68016-655 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 STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) STEARIC ACID (UNII: 4ELV7Z65AP) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code G323 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-655-10 100 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)