NDC Code(s) : 63187-650-30
Packager : Proficient Rx LP

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BismatrolBismuth subsalicylate TABLET, CHEWABLE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-650(NDC:0904-1315)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISMUTH SUBSALICYLATE(UNII: 62TEY51RR1)
(BISMUTH CATION - UNII:ZS9CD1I8YE) 		BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
D&C RED NO. 27(UNII: 2LRS185U6K)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
STARCH, CORN(UNII: O8232NY3SJ)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
Product Characteristics
Color pink Score no score
Shape ROUND Size 17 mm
Flavor Imprint Code GDC122
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63187-650-305 in 1 CARTON 12/01/2018
16 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M008 01/03/2003

LABELER - Proficient Rx LP(079196022)

Establishment
Name Address ID/FEI Business Operations
Proficient Rx LP 079196022 RELABEL(63187-650)

PRINCIPAL DISPLAY PANEL

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Bismatrol Chewable Tablets

soothing, coating action provides fast relief for heartburn, indigestion, nausea, upset stomach and diarrhea

compare to the active ingredient in Pepto-Bismol®

30 chewable tablets

63187-650-30