Label: ACETAMINOPHEN tablet

  • NDC Code(s): 0363-9798-05, 0363-9798-10, 0363-9798-15, 0363-9798-21, view more
    0363-9798-24, 0363-9798-37
  • Packager: WALGREEN CO.
  • 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 Gelcap)

    Acetaminophen, USP 500 mg

  • Purpose

    ​Pain reliever/fever reducer

  • Uses

    ■ temporarily relieves minor aches and pains due to:
    ■ headache
    ■ muscular aches
    ■ backache
    ■ minor pain of arthritis
    ■ toothache
    ■ he common cold
    ■ 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 have ever had an allergic reaction to this product or any of its ingredients

  • 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.

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

  • Overdose warning

    In case of accidental overdose, get medical help or contact a Poison Control Centerright 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 gelcaps every 6 hours while symptoms last
    ■ do not take more than 6 gelcaps 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

    ■ avoid high humidity
    ■ see end panel for lot number and expiration date

  • Inactive Ingredients

    ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, yellow iron Oxide.

  • Questions or comments ?

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

  • PDP

    375 ct225 ct150 ct50ct carton100ct carton24ct carton

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9798
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    AMMONIA (UNII: 5138Q19F1X)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorgray (Encapsulated with red opaque and blue gray opaque hard gelatin shells) Scorescore with uneven pieces
    ShapeOVALSize19mm
    FlavorImprint Code G1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9798-2424 in 1 BOTTLE; Type 0: Not a Combination Product09/24/2021
    2NDC:0363-9798-0550 in 1 BOTTLE; Type 0: Not a Combination Product09/24/2021
    3NDC:0363-9798-15150 in 1 BOTTLE; Type 0: Not a Combination Product09/24/2022
    4NDC:0363-9798-21225 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2022
    5NDC:0363-9798-37375 in 1 BOTTLE; Type 0: Not a Combination Product06/25/2022
    6NDC:0363-9798-10100 in 1 BOTTLE; Type 0: Not a Combination Product09/24/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/24/2021
    Labeler - WALGREEN CO. (008965063)