GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [CARDINAL HEALTH]

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GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [CARDINAL HEALTH]
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NDC 37205-112-78
Set ID 359bf5e1-1c08-4c52-bfee-e490857e56da
Category HUMAN OTC DRUG LABEL
Packager CARDINAL HEALTH
Generic Name
Product Class
Product Number
Application Number PART332
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  • Active ingredient (in each tablet)

    Simethicone 80 mg

  • Purpose

    Antigas

  • Uses

    • relieves these symptoms associated with gas:
      • bloating
      • pressure
      • fullness
      • stuffed feeling 
  • Warnings

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

  • Directions

    • chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
    • do not exceed 6 tablets per day unless directed by a doctor
  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • avoid high humidity and excessive heat above 40ºC (104ºF) 
    • use by expiration date on package
  • Inactive ingredients

    dextrose, peppermint flavor, silica gel, sorbitol, stearic acid, talc, tri-calcium phosphate

  • Principal Display Panel

    NDC 37205-112-78

    LEADER®

    Gas Relief
    Simethicone 80 mg

    Anti Gas
    • Pressure   • Bloating   • Discomfort

    Fast Acting

    SATISFACTION GUARANTEED

    Mint Flavored

    100 CHEWABLE TABLETS

    50844  REV0712G13712

    Questions or comments? 1-800-426-9391

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

    CIN 2804144

    All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

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

    Leader 44-137

    Leader 44-137

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-112
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize13mm
    FlavorPEPPERMINTImprint Code 44;137
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-112-78100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/28/199402/04/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33207/28/199402/04/2023
    Labeler - CARDINAL HEALTH (097537435)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(37205-112)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(37205-112)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(37205-112)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(37205-112)
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