Label: ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 29, 2023

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  • Drug Facts

    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 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 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° to 25°C (68° to 77°F)
    • do not use if printed foil seal under cap is torn or missing.
  • Inactive ingredients

    povidone, pregelatinized starch (maize), stearic acid.

  • Questions or comments?

    call 1-855-274-4122

    Distributed by:
    AUROHEALTH LLC.
    279 Princeton- Hightstown Road,
    East Windsor, NJ 08520

    Made in India

    Code: TS/DRUGS/16/2014

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (750 Caplets Bottle)

    NDC 58602-776-88Primary Health

    Compare to the active ingredient in
    Tylenol ® Extra strength Caplets *     

    See New Warnings Information & Directions
    EXTRA STRENGTH
    For Adults
    Pain Relief
    Acetaminophen Caplets 500 mg
    Pain reliever/Fever reducer
    N 79

    750 CAPLETS
    500 mg each
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (750 Caplets Bottle)

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN EXTRA STRENGTH 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-776
    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)  
    PALMITOSTEARIC ACID (UNII: Q8Y7S3B85M)  
    Product Characteristics
    Colorwhite (White to off White) Scoreno score
    ShapeCAPSULE (Biconvex) Size18mm
    FlavorImprint Code N79
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-776-88750 in 1 BOTTLE; Type 0: Not a Combination Product09/02/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/02/2022
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777analysis(58602-776) , manufacture(58602-776)
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