Label: ACETAMINOPHEN tablet, coated
- NDC Code(s): 11673-838-01, 11673-838-05, 11673-838-26, 11673-838-50
- 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
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Directions: Do not take more than directed (see overdose warning)
adults and children 12 years and over: take 2 caplets every 4 to 6 hours while symptoms last
do not take more than 8 caplets in 24 hours
do not take for more than 10 days unless directed by a doctor
children 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 does (overdose) of acetaminophen any may cause lier damage.
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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 4,000 mg of acetaminophen 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.
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-838 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 MINERAL OIL (UNII: T5L8T28FGP) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape OVAL Size 17mm Flavor Imprint Code TCL341 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-838-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2020 2 NDC:11673-838-05 50 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2020 3 NDC:11673-838-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2020 4 NDC:11673-838-26 225 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(11673-838)