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

  • NDC Code(s): 51013-436-22
  • 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 March 27, 2018

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Simethicone 180 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

    Keep out of reach of children. 

  • Directions

    • swallow 1 or 2 softgels as needed after a meal
    • do not exceed two softgels per day except under the advice and supervision of a physician
  • Other information

    • store at room temperature 59º - 86ºF (15º - 30ºC)
  • Inactive ingredients

    FD&C yellow#6, gelatin, glycerin, purified water and white edible ink

  • Questions or comments?

    Call toll free: 1-855-215-8180

  • PRINCIPAL DISPLAY PANEL

    Ultra Strength Gas Relief

    Simethicone 180 mg Anti-gas  60 Softgels

    NDC 51013-436-22

    *Compare to the active ingredient in PHAZYME® Ultra Strength

    1

    2

  • INGREDIENTS AND APPEARANCE
    ULTRA STRENGTH GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-436
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colororange (clear) Scoreno score
    Shapecapsule (oval) Size10mm
    FlavorImprint Code PC3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51013-436-221 in 1 CARTON03/27/2018
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33203/27/2018
    Labeler - PURACAP PHARMACEUTICAL LLC (962106329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(51013-436) , analysis(51013-436)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!