DEVROM- bismuth subgallate capsule

Devrom by

Drug Labeling and Warnings

Devrom by is a Otc medication manufactured, distributed, or labeled by The Parthenon Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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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

INGREDIENTS AND APPEARANCE

DEVROM 
bismuth subgallate capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49309-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBGALLATE (UNII: YIW503MI7V) (BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBGALLATE	200 mg

Inactive Ingredients
Ingredient Name	Strength
magnesium stearate (UNII: 70097M6I30)
microcrystalline cellulose (UNII: OP1R32D61U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
croscarmellose sodium (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	YELLOW (CLEAR)	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	Devrom
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49309-002-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part357I	12/01/2018

Labeler - The Parthenon Co., Inc. (073014607)