Label: LEADER EXTRA STRENGTH ACETAMINOPHEN- acetaminophen capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Acetaminophen 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 DOCTOR

    Ask a doctor before use if you have liver disease

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

  • STOP USE

    ■ 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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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 softgels every 6 hours while
    symptoms last
    ■ do not take more than 6 softgels 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

    ■ each softgel contains: sodium 7 mg
    ■ store between 15°-30°C (59°-86°F)

  • Inactive ingredients

    FD&C Red #40, gelatin, glycerin, polyethylene glycol 400,
    potassium hydroxide, povidone, propylene glycol, purified
    water, sodium hydroxide, sorbitol, sorbitol sorbitan solution
    titanium dioxide

  • QUESTIONS

    Questions or Comments? 1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    Leader™ Extra Strength Acetaminophen

    Compare to the active ingredient
    in Tylenol® Extra Strength*
    Liquid-Filled Capsules**


    EXTRA STRENGTH
    Acetaminophen USP 500mg

    Pain Reliever; Fever reducer
    Aspirin free
    40 SOFTGELS**
    **Liquid filled capsules

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

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

    Distributed by: CARDINAL HEALTH
    DUBLIN, OHIO 43017
    Made in India
    CIN 5546221

    image description

  • INGREDIENTS AND APPEARANCE
    LEADER EXTRA STRENGTH ACETAMINOPHEN 
    acetaminophen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0509
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorred (transparent) Scoreno score
    ShapeOVALSize23mm
    FlavorGRAPEImprint Code 710
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0509-140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/10/2019
    Labeler - Cardinal Health (063997360)
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