Application Nr Approved Date Route Status External Links
ANDA091292 2011-05-20 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Anti-Diarrheal

All Formulated Excipients (13 Total)

Name Structure Kind Function Status
1. Anhydrous Citric Acid ANHYDROUS CITRIC ACID Molecular
2. Carboxymethylcellulose Sodium, Unspecified Form CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM Unresolved
3. D&c Yellow No. 10 D&C YELLOW NO. 10 Molecular DYE-Dye
4. Fd&c Blue No. 1 FD&C BLUE NO. 1 Molecular DYE-Dye
5. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
8. Water WATER Molecular
9. Simethicone SIMETHICONE Unresolved
10. Sodium Benzoate SODIUM BENZOATE Molecular
11. Sucralose SUCRALOSE Molecular NNS-Non-nutritive sweetener REG-Food additives for which a petition has been filed and a regulation issued.
12. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
13. Xanthan Gum XANTHAN GUM Unresolved EMUL-Emulsifier FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE ZINC537928

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