PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 70000]

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PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 70000]
PDF | XML
NDC 70000-0137-1, 70000-0137-2
Set ID e41e63a2-28d4-4a81-93f9-1b473a795c3a
Category HUMAN OTC DRUG LABEL
Packager Cardinal Health (Leader) 70000
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredient (in each capsule)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/ fever reducer

  • 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
  • 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 (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.

  • Directions

    • do not take more than 6 capsules in any 24-hour period
    • do not take more than directed (see Overdose warning)
    • adults and children 12 years and over
      • take 2 capsules every 6 hours while symptoms  last
      • do not take more than 10 days unless directed by a doctor
    • children under 12 years: do not use
  • Other information

    • each capsule contains: sodium 9 mg
    • store between 15-30ºC (59-86ºF)
  • Inactive ingredients

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

  • Questions or comments?

     Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Extra Strength

    Acetaminophen

    500 mg | Pain Reliever / Fever Reducer

    FOR ADULTS

    Alcohol Free

    SOFTGELS*

    (*Liquid-Filled Capsules)

    COMPARE TO TYLENOL® EXTRA STRENGTH active ingredient**

    **This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Extra Strength.

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    www.myleader.com 1-800-200-6313

  • Product Label

    Acetaminophen 500 mg

    LEADER Extra Strength Acetaminophen Softgels

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER  EXTRA STRENGTH
    acetaminophen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0137
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code 710
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0137-11 in 1 BOX10/31/201603/01/2023
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:70000-0137-2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/31/201603/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/31/201603/01/2023
    Labeler - Cardinal Health (Leader) 70000 (063997360)
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