Label: GAS RELIEF- simethicone tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 March 25, 2020

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

  • 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)