Label: EXTRA 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 125 mg

  • Purpose

    Purpose

    Anti-gas

  • Use

    Use for the relief of

    • pressure, bloating and fullness commonly referred to as gas

  • Warning

    Warning

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    Directions

    • adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime
    • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
  • Other information

    Other information

    • store at room temperature
    • protect from light, heat and moistur e
  • Inactive ingredients

    Inactive ingredients

    D&C Yellow 10, FD&C Red #40, FD&C Blue 1, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    722T_Kroger_Simethicone capsules 125mg

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH GAS RELIEF 
    simethicone capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-722
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code 105
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41226-722-302 in 1 CARTON05/05/2023
    115 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33205/05/2023
    Labeler - KROGER COMPANY (006999528)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(41226-722)
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