Application Nr Approved Date Route Status External Links
ANDA040151 1997-08-26 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Promethazine Hydrochloride And Codeine Phosphate Syrup Is Indicated For The Temporary Relief Of Coughs And Upper Respiratory Symptoms Associated With Allergy Or The Common Cold.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Citric Acid Monohydrate CITRIC ACID MONOHYDRATE Molecular
2. Fd&c Yellow No. 6 FD&C YELLOW NO. 6 Molecular DYE-Dye
3. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
4. Saccharin Sodium SACCHARIN SODIUM Molecular
5. Sodium Benzoate SODIUM BENZOATE Molecular
6. Sodium Citrate, Unspecified Form SODIUM CITRATE, UNSPECIFIED FORM Molecular
7. Sodium Propionate SODIUM PROPIONATE Molecular MISC-Miscellaneous , PRES-Chemical preservative GRAS-Generally recognized as safe.

Active Ingredients ( 2 Total)

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