Label: ACETAMINOPHEN tablet

  • NDC Code(s): 69842-298-05, 69842-298-10, 69842-298-15, 69842-298-21, view more
    69842-298-24, 69842-298-30, 69842-298-40, 69842-298-60
  • Packager: CVS PHARMACY, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 28, 2023

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.

  • Directions

    ■ do not take more than directed

    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, black iron oxide irradiated, colloidal silicon dioxide, croscarmellose sodium, 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 9:00 AM to 4:30 PM EST.

  • Acetaminophen, USP 500 mg Rapid Release Gelcaps

    300 count225 count100 count50 count24 count

  • PRINCIPAL DISPLAY PANEL

    150 count600 count80 count

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-298
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    AMMONIA (UNII: 5138Q19F1X)  
    Product Characteristics
    Colorgray (Encapsulated with red opaque and blue gray opaque hard gelatin shells) Scoreno score
    ShapeOVALSize19mm
    FlavorImprint Code G1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-298-2424 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
    2NDC:69842-298-0550 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
    3NDC:69842-298-10100 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
    4NDC:69842-298-21225 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
    5NDC:69842-298-30300 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
    6NDC:69842-298-40400 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
    7NDC:69842-298-60600 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
    8NDC:69842-298-15150 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01304/01/2019
    Labeler - CVS PHARMACY, INC (062312574)