Label: PAIN RELIEVER- acetaminophen tablet

  • NDC Code(s): 0363-0792-29, 0363-0792-35, 0363-0792-40
  • Packager: WALGREEN CO.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2023

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  • Drug Facts

    Active ingredient (in each caplet)

    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
  • 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

    • 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 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 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 at 20° to 25°C (68° to 77°F)
    • do not use if carton is opened, or seal under cap is torn or missing.
  • Inactive ingredients

    colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, pregelatinized starch, propylene glycol, sodium starch glycolate, talc, titanium dioxide.

  • Questions or comments?

    1-855-274-4122

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED
    Walgreens.com ©2019 Walgreen Co.

    Code: TS/DRUGS/16/2014

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (225 Caplets Bottle)

    Walgreens

    NDC 0363-0792-35

    FOR ADULTS
    Pain Relief
    ACETAMINOPHEN 500 mg /
    PAIN RELIEVER / FEVER REDUCER

    EXTRA STRENGTH
    CAPLETS

    225 CAPLETS

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg ( 100 Caplets Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (225 Caplets Carton Label)

    Walgreens

    Compare to Tylenol ® Extra strength
    Caplets     active ingredient *     

    NDC 0363-0792-35

    FOR ADULTS
    PAIN RELIEVER
    ACETAMINOPHEN 500MG /
    PAIN RELIEVER / FEVER REDUCER

    EXTRA STRENGTH
    CAPLETS

    225 CAPLETS


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (225 Caplets Carton Label)

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0792
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (White to off White) Scoreno score
    ShapeCAPSULE (Biconvex) Size18mm
    FlavorImprint Code N79
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0792-29150 in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
    2NDC:0363-0792-351 in 1 CARTON06/12/2020
    2225 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0363-0792-40500 in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01306/12/2020
    Labeler - WALGREEN CO. (008965063)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777manufacture(0363-0792)
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