Label: ACETAMINOPHEN tablet, coated
- NDC Code(s): 11673-841-01
- Packager: TARGET CORPORATION
- 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 September 13, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
DOSAGE & ADMINISTRATION
Directions
do not take more than directed (see overdose warning)
adults and children 12 years and over
take 2 tablets (1,000 mg) every 6 hours while symptoms last
do not take more than 6 tablets (3,000 ng) in 24 hours, unless directed by a doctor
do not take for more than 10 days unless directed by a doctorchildren under 12 years
do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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more than 12 tablets in 24 hours
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with other drugs containing acetaminophen
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3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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skin reddening
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blisters
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rashIf a skin reaction occurs, stop use and seek medical help right away.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-841 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 POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code TCL340 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-841-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/01/2020 Labeler - TARGET CORPORATION (006961700) Registrant - TIME CAP LABORATORIES, INC (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC. 037052099 manufacture(11673-841)
