Other
Drug Facts
distributed by
The Parthenon Company, Inc.
Devrom Tablet, Chewable
FDA Label NDC 49309-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Parthenon Co., Inc. for the product Devrom (NDC 49309-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, use, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - Keep Out Of Reach Of Children
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
Principal Display Panel - 100 Tablet Bottle Label
Devrom®
(200 mg bismuth subgallate)
Internal Deodarant
100 chewable tablets
Principal Display Panel (100 Tablet Bottle Label)
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