Label: ACETAMINOPHEN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 49483-252-01 - Packager: TIME CAP LABORATORIES, INC
- 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 November 22, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Liver warning:This product contains Acetaminophen. Severe liver damage may occur if you have:
more than 8 tablets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include *skin redding *blisters *rash.
If a skin reaction occurs, stop use and seek medical help right away.
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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OVERDOSAGE
Overdose warning:
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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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 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 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 dose (overdose) of acetaminophen and may cause liver damage
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-252 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 POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 12mm Flavor Imprint Code TCL252 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-252-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/17/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 07/12/2011 Labeler - TIME CAP LABORATORIES, INC (037052099) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC 037052099 manufacture(49483-252)
