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

  • NDC Code(s): 51013-127-04, 51013-127-22
  • Packager: PURACAP PHARMACEUTICAL LLC
  • 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 December 20, 2019

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  • Active ingredient (in each softgel)

    Simethicone 250 mg

  • Purpose

    Anti-gas

  • Use

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

    Stop use and ask a doctor if

    condition persists

    Keep out of reach of children.

  • Directions

    • swallow one or two softgels after a meal
    • do not exceed two softgels per 24 hours except under the advice and supervision of a physician
  • Other information

    • store at room temperature 59°-86°F (15°-30°C)
  • Inactive ingredients

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

  • Questions or Comments?

    Call: 1-855-215-8180

  • PRINCIPAL DISPLAY PANEL - 24ct

    CVS MAXIMUM STRENGTH GAS RELIEF Anti-gas

    SIMETHICONE 250 mg

    NDC 51013-127-04

    Compare to the active ingredient in PHAZYME® Maximum Strength

    24 Liquid-Filled SoftGels

    Carton 24ct

  • PRINCIPAL DISPLAY PANEL - 60ct

    CVS MAXIMUM STRENGTH GAS RELIEF Anti-gas

    SIMETHICONE 250 mg

    NDC 51013-127-22

    Compare to the active ingredient in PHAZYME® Maximum Strength

    60 Liquid-Filled SoftGels

    Carton 60ct

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-127
    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 (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpurpleScoreno score
    Shapecapsule (oval) Size13mm
    FlavorImprint Code PC31
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51013-127-042 in 1 CARTON01/11/2016
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:51013-127-221 in 1 CARTON01/11/2016
    260 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33201/11/2016
    Labeler - PURACAP PHARMACEUTICAL LLC (962106329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(51013-127) , analysis(51013-127)
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