Devrom Capsule
FDA Label NDC 49309-002

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 49309-002). 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 capsule), purpose, indications & usage, otc - pregnancy or breast feeding, 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

Other

Drug Facts

Manufactured for and distributed by
The Parthenon Company, Inc.

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).

Otc - Pregnancy Or Breast Feeding

  • 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 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

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)

Principal Display Panel (200 mg Capsule Bottle Label)

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