Label: MAXIMUM STRENGTH GAS RELIEF SOFTGEL- simethicone capsule, liquid filled

  • NDC Code(s): 70000-0632-1
  • Packager: Cardinal Health 110, LLC. DBA Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 11, 2024

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  • Drug Facts

  • Active ingredient (in each softgel)

    Simethicone 250 mg

  • Purpose

    Anti-gas

  • Uses

    • relieves bloating, pressure or fullness commonly referred to as gas

  • Warnings

    Stop use and ask a doctor if condition persists.

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

    Keep out of reach of children.

  • Directions

    • Swallow one or two softgels as symptoms occur
    • do not exceed 2 softgels per 24 hours except under the advice and supervision of a physician

  • Other information

    • store at room temperature 20-25°C (68-77°F)
    • protect from heat, humidity and light

  • Inactive ingredients

    D&C red #33, edible ink, FD&C blue #1, gelatin, glycerin, purified water

  • Questions or comments?

    1-888-577-8033 Monday- Friday 8am - 4pm EST

  • SPL UNCLASSIFIED SECTION

    LEADER™

    Relieves:
      Bloating
      Pressure
      Fullness

    COMPARE TO PHAZYME® MAXIMUM STRENGTH active ingredient*

    100% Money Back Guarantee 

    TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS CUT TORN OR MISSING

    *This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme® Maximum Strength.

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

    ©2023 CARDINAL HEALTH, LEADER, and LOGOs are trademarks of Cardinal Health. All other marks are the property of their respective owners.

    Product of United Arab Emirates

  • Packaging

    Cardnl-antigas-0632

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH GAS RELIEF SOFTGEL 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0632
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 813
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0632-11 in 1 CARTON02/20/2023
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00202/20/2023
    Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
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