Label: EXTRA STRENGTH PAIN RELIEVER- acetaminophen tablet 

  • Label RSS
  • NDC Code(s): 37205-659-72, 37205-659-78
  • Packager: CARDINAL HEALTH
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/13

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Acetaminophen 500 mg

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    • temporarily relieves minor aches and pains due to:

      • headache

      • the common cold

      • backache

      • minor pain of arthritis

      • toothache

      • muscular aches

      • premenstrual and menstrual cramps

    • temporarily reduces fever

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  • Warnings

    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. 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

    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.

    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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions

    • do not take more than directed (see overdose warning)

    • adults and children 12 years and over

      • take 2 tablets every 4 to 6 hours while symptoms last

      • do not take more than 8 tablets in 24 hours

      • do not take for more than 10 days unless directed by a doctor

    • children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

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  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

    • see end flap for expiration date and lot number

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  • Inactive ingredients

    corn starch, povidone, sodium starch glycolate*, stearic acid

    *may contain this ingredient

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  • Questions or comments?

    1-800-426-9391 

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  • Principal Display Panel

    NDC 37205-659-78

    LEADER®

    Compare to Extra Strength Tylenol® active ingredient†

    EXTRA STRENGTH
    Pain Reliever
    Acetaminophen 500 mg
    Pain Reliever/Fever Reducer
    Contains No Aspirin

    100 TABLETS

    †This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®.
    50844   ORG021314812

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017
    CIN 1059773
    www.myleader.com
    1-800-200-6313

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Leader 44-148

    Leader 44-148

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  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEVER 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37205-659
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    STEARIC ACID  
    STARCH, CORN  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND Size 12mm
    Flavor Imprint Code 44;148
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-659-72 1 in 1 CARTON
    1 60 in 1 BOTTLE
    2 NDC:37205-659-78 1 in 1 CARTON
    2 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 01/21/1993
    Labeler - CARDINAL HEALTH (097537435)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(37205-659)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(37205-659)
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