Label: ACETAMINOPHEN tablet, coated

  • NDC Code(s): 41226-697-01, 41226-697-34, 41226-697-42
  • Packager: Kroger Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 13, 2024

If you are a consumer or patient please visit this version.

  • Drug Facts

    Acetaminophen 500 mg

  • ACTIVE INGREDIENT

    Acetaminophen 500 mg

  • PURPOSE

    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses

    temporarily relieves minor aches and pains due to:

    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • premenstrual and menstrual cramps

    temporarily reduces fever

  • 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

    Do not use
    •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    •if you are allergic to acetaminophen or any of the inactive ingredients in this product

  • ASK DOCTOR

    Ask a doctor before use if you have liver disease

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

  • STOP USE

    Stop use and ask a doctor if
    •pain gets worse or lasts more than 10 days
    •fever gets worse or lasts more than 3 days
    •new symptoms occur
    •redness or swelling is present
    These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • 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

    • store between 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, mica based pearlescent pigment, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, povidone, pregelatinized starch

  • QUESTIONS

    Questions or comments? Call 1-800-632-6900

  • PRINCIPAL DISPLAY PANEL

    apap-rr-225s-labelapap-rr-100s-labelapap-rr-100s-ifcacetaminophen 500 mg-24ct-carton

    acetaminophen 500 mg-24ct-Bottle label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-697
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorredScoreno score
    ShapeCAPSULE (biconvex tablets) Size17mm
    FlavorImprint Code TCL;A71
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41226-697-421 in 1 CARTON04/10/2021
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:41226-697-34225 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2024
    3NDC:41226-697-011 in 1 CARTON04/15/2024
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01304/10/2021
    Labeler - Kroger Company (006999528)
    Registrant - Time Cap Laboratories, Inc. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(41226-697)