Label: ULTRA STRENGTH GAS RELIEF- simethicone capsule

  • 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 May 5, 2023

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each softgel)
    Simethicone 180 mg

  • PURPOSE

    Purpose
    Anti-gas

  • INDICATIONS & USAGE

    Uses
    • Relieves bloating, pressure or fullness commonly referred to as gas.

  • WARNINGS

    Warnings

    Stop use and ask a doctor if condition persists.

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

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

  • STORAGE AND HANDLING

    Other information
    • Store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients
    FD&C Yellow No. 6, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

  • QUESTIONS

    Questions or comments? Call 1-800-632-6900

  • PRINCIPAL DISPLAY PANEL

    717T-KR-Simethicone-30s-label717T-KR-Simethicone-30s-ifc

  • INGREDIENTS AND APPEARANCE
    ULTRA STRENGTH GAS RELIEF 
    simethicone capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-717
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colororange (Orange Translucent) Scoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 104
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41226-717-301 in 1 CARTON05/05/2023
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00205/05/2023
    Labeler - KROGER COMPANY (006999528)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(41226-717)
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