Label: DEVROM- bismuth subgallate capsule

  • NDC Code(s): 49309-002-01
  • Packager: The Parthenon Co., Inc.
  • 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 17, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each capsule)

    Bismuth subgallate 200 mg

  • Purpose

    Internal Deodorant

  • INDICATIONS & USAGE

    Use for eliminating or reducing odor from flatulence (gas) and stool (feces).

  • Warnings

    • If pregnant or breast-feeding, ask a health professional before use.
    • When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.
    • In case of overdose, get medical help or contact a Poison Control Center right away.

    • Keep out of reach of children.
  • Directions

    • Adults and children 12 years and over: 1 to 2 capsules up to four times daily or as directed by physician.
    • Do not exceed 8 capsules in 24 hours.
    • Children under 12 years: ask a doctor.
  • Other Information

    • This product cannot be expected to be effective in the reduction of odor due to faulty personal hygiene.
    • Does not contain gluten, lactose, or salicylates.
    • Store in a cool, dry place. Do not use if outer safety seal or printed inner safety seal is broken.
  • Inactive ingredients

    microcrystalline cellulose, maltodextrine, croscarmellose, silica, magnesium stearate.

  • Questions?

    1-800-453-8898

  • SPL UNCLASSIFIED SECTION

    Manufactured for and distributed by
    The Parthenon Company, Inc.

  • PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Label

    Devrom®
    (200 mg bismuth subgallate)

    Internal Deodorant
    100 capsules

    PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Label
  • INGREDIENTS AND APPEARANCE
    DEVROM 
    bismuth subgallate capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49309-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBGALLATE (UNII: YIW503MI7V) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBGALLATE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    magnesium stearate (UNII: 70097M6I30)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    croscarmellose sodium (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorYELLOW (CLEAR) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code Devrom
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49309-002-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart357I12/01/2018
    Labeler - The Parthenon Co., Inc. (073014607)
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