Label: ACETAMINOPHEN tablet

  • NDC Code(s): 70010-161-01, 70010-161-05, 70010-161-10
  • Packager: Granules Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated February 6, 2024

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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 24 hours.


    • with other drugs containing acetaminophen

    • 3 or more alcoholic drinks everyday 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 drugs 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 other 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 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

    Over dose warning: In case of overdose, get medical help or Contact 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 20-25°C (68-77°F). See USP Controlled Room Temparature

    • avoid high humidity


    • See end panel for lot number and expiration date

  • INACTIVE INGREDIENTS

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

  • QUESTIONS OR COMMENTS ?

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

    +All trademarkes are property of their reapective owners.

    This product is not affliated with the makers/owners of

    Extra Strength Tylenol ® Caplets.

    Distributed by:

    Granules Pharmaceuticals INc.,

    Chantilly, VA 20151

    MADE IN INDIA

    Rev.08/21

  • PRINCIPAL DISPLAY PANEL

    100-count-bottle-label

    100-count-bottle-carton-label

    500-count-bottle-label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70010-161
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Product Characteristics
    Colorwhite (White to off-White) Scoreno score
    ShapeCAPSULE (Caplet shape) Size17mm
    FlavorImprint Code G551
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70010-161-011 in 1 CARTON02/15/2022
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:70010-161-05500 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2022
    3NDC:70010-161-101000 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only02/15/2022
    Labeler - Granules Pharmaceuticals Inc. (079825711)
    Registrant - Granules India Limited (918609236)
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