Label: ACETAMINOPHEN tablet, coated
- NDC Code(s): 41226-341-01, 41226-341-10, 41226-341-15, 41226-341-50
- Packager: Kroger Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 13, 2024
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- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- 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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DOSAGE & ADMINISTRATION
Directions
Do not take more than directed.See overdose warning
adults and children 12 years and over:- take 2 caplets every 6 hours while symptoms last
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
children under 12 years: ask a doctor
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41226-341 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) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) HYPROMELLOSES (UNII: 3NXW29V3WO) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape OVAL (caplet) Size 17mm Flavor Imprint Code TCL341 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41226-341-01 1 in 1 CARTON 06/15/2021 1 100 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:41226-341-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/20/2021 3 NDC:41226-341-10 1 in 1 PACKAGE 05/20/2021 3 500 in 1 BOTTLE 3 500 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:41226-341-15 150 in 1 BOTTLE; Type 0: Not a Combination Product 04/15/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 05/20/2021 Labeler - Kroger Company (006999528) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC. 037052099 manufacture(41226-341)