Label: ACETAMINOPHEN tablet

  • NDC Code(s): 69848-003-10, 69848-003-17, 69848-003-24
  • Packager: Granules USA, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 28, 2023

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  • 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 the reach of children.

  • Overdose warning

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Promt 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 between 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

    hydroxypropyl methyl cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

  • Questions or comments?

    call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.

  • PRINCIPAL DISPLAY PANEL

    24 count175 Count

    100 Count

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69848-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code G;551
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69848-003-2424 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
    2NDC:69848-003-10100 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
    3NDC:69848-003-17175 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/01/2019
    Labeler - Granules USA, Inc (137098864)
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