Label: DEVROM- bismuth subgallate capsule
- NDC Code(s): 49309-002-01
- 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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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each capsule)
- Purpose
- INDICATIONS & USAGE
- Warnings
- Directions
- Other Information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Label
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INGREDIENTS AND APPEARANCE
DEVROM
bismuth subgallate capsuleProduct 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)