Label: MAXIMUM STRENGTH GAS RELIEF SOFTGEL-60CT- simethicone capsule, liquid filled

  • 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 July 25, 2023

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  • Drug Facts

  • Active ingredient (in each softgel)

    Simethicone 250 mg

  • Purpose

    Anti-gas

  • Uses

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

    Stop use and ask a doctor if condition persists.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

  • Directions

    • Swallow one or two softgels as symptoms occur
    • do not exceed 2 softgels per 24 hours except under the advice and supervision of a physician
  • Other information

    • store at room temperature 20-25°C (68-77°F)
    • protect from heat, humidity and light
    • TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS CUT TORN OR MISSING
  • Inactive ingredients

    D&C Red #33, FD&C Blue #1, gelatin, glycerin, povidone, purified water, sorbitol

  • Questions or comments?

    1-888-577-8033

  • SPL UNCLASSIFIED SECTION

    Compare to Maximum Strength Phazyme® active ingredient*

    MADE WITH PRIDE AND CARE FOR H-E-B®,
    SAN ANTONIO, TEXAS 78204

    100% GUARANTEE promise

    If you aren't completely pleased with this product, we'll be happy to replace it or refund your money. You have our word on it.

    *Phazyme® is a registered trademark of C.B. Fleet Company Inc.

  • Packaging

    gasrelief813

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH GAS RELIEF SOFTGEL-60CT 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-813
    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)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 813
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-813-061 in 1 CARTON02/16/2023
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33202/16/2023
    Labeler - HEB (007924756)
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