Label: ACETAMINOPHEN tablet

  • NDC Code(s): 41415-538-05, 41415-538-10
  • Packager: PUBLIX SUPERMARKETS, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 9, 2024

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

  • Active ingredient (in each coated tablet)

    Acetaminophen USP, 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses


    ■ temporarily relieves minor aches and pains due to:
    ■ the common cold ■ headache
    ■ backache ■ minor pain of arthritis
    ■ toothache ■ muscular aches
    ■ premenstrual and menstrual cramps
    ■ temporarily reduces fever

  • 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


    ■ 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 a doctor before use if you have

    liver disease

  • Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin

  • 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

  • If pregnant or breast-feeding

    ask a health professional before use

  • 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 childreneven if you do not notice any signs or symptoms.

  • Directions

    ■ do not take more than directed (see overdose warning)

    adults and children 12 years and over
    ■ take 2 tablets every 6 hours while symptoms last
    ■ do not take more than 6 tablets 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 at 20-25°C (68-77°F). See USP Controlled Room Temperature.
    ■ see end panel for lot number and expiration date

  • Inactive ingredients


    FD&C red no. 40, FD&C yellow no. 6, lecithin, polyethylene glycol, polyvinyl alcohol, povidone k-30, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide

  • Questions or comments?

    call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

  • Principal display panel

    50ct100ct

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41415-538
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code L;1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41415-538-0550 in 1 BOTTLE; Type 0: Not a Combination Product09/09/2024
    2NDC:41415-538-10100 in 1 BOTTLE; Type 0: Not a Combination Product09/09/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/09/2024
    Labeler - PUBLIX SUPERMARKETS, INC (006922009)