Label: ACETAMINOPHEN tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 2, 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 the reach of children.

    Keep out of the 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.

  • 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 take 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
    ■ do not use if imprinted safety seal under cap is broken or missing

  • Inactive ingredients

    FD&C red no. 40, FD&C yellow no. 6, lecithin, polyethylene glycol, povidone k-30, polyvinyl alcohol, 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

    225ct label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9538
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code L;1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9538-25225 in 1 BOTTLE; Type 0: Not a Combination Product03/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/03/2023
    Labeler - WALGREENS (008965063)