DEVROM- bismuth subgallate tablet, chewable 
The Parthenon Co., Inc.

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.

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Devrom®

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

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
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)

Revised: 12/2018
Document Id: 7c481f92-32e0-44ff-8679-25cbe5928ecd
Set id: 6a9408b1-9085-42e6-9104-c6986d5446a9
Version: 1
Effective Time: 20181217
 
The Parthenon Co., Inc.