Label: ACETAMINOPHEN tablet, coated
- NDC Code(s): 41226-697-01, 41226-697-34, 41226-697-42
- Packager: Kroger Company
- Category: HUMAN OTC DRUG LABEL
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 productAllergy 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
-
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:41226-697 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 K30 (UNII: U725QWY32X) STARCH, CORN (UNII: O8232NY3SJ) MICA (UNII: V8A1AW0880) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CROSPOVIDONE (UNII: 2S7830E561) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color red Score no score Shape CAPSULE (biconvex tablets) Size 17mm Flavor Imprint Code TCL;A71 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41226-697-42 1 in 1 CARTON 04/10/2021 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:41226-697-34 225 in 1 BOTTLE; Type 0: Not a Combination Product 04/15/2024 3 NDC:41226-697-01 1 in 1 CARTON 04/15/2024 3 100 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 04/10/2021 Labeler - Kroger Company (006999528) Registrant - Time Cap Laboratories, Inc. (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 manufacture(41226-697)