Label: ACETAMINOPHEN tablet

  • NDC Code(s): 21130-353-15
  • Packager: BETTER LIVING BRANDS LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2023

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  • Active ingredient (in each 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 4,000mg 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

  • 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 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 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 Ingredient

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

  • Questions or Comments?

    call 1-800-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

  • Principal Display Panel

    15

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-353
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    Colorwhite (White to off-white) Scoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code G;551
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-353-15150 in 1 BOTTLE; Type 0: Not a Combination Product12/12/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01312/12/2022
    Labeler - BETTER LIVING BRANDS LLC. (009137209)
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