Label: DEVROM- bismuth subgallate tablet, chewable

  • NDC Code(s): 49309-001-01
  • 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 tablet)

    Bismuth subgallate 200 mg

  • Purpose

    Internal Deodorant

  • 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 tablets up to four times daily. Do not exceed 8 tablets 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.

  • Inactive ingredients

    magnesium stearate, microcrystalline cellulose, natural banana flavor. starch, talc, xylitol.

  • Questions?

    1-800-453-8898

  • SPL UNCLASSIFIED SECTION

    distributed by
    The Parthenon Company, Inc.

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    Devrom®
    (200 mg bismuth subgallate)

    Internal Deodarant
    100 chewable tablets

    PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    DEVROM 
    bismuth subgallate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49309-001
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    talc (UNII: 7SEV7J4R1U)  
    xylitol (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize11mm
    FlavorBANANAImprint Code D
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49309-001-01100 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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