Application Nr Approved Date Route Status External Links
ANDA088763 1984-10-31 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 (9 Total)

Name Structure Kind Function Status
1. Citric Acid Monohydrate CITRIC ACID MONOHYDRATE Molecular
2. Corn Syrup CORN SYRUP Unresolved NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
3. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
4. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
5. Propylparaben PROPYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
6. Water WATER Molecular
7. Saccharin Sodium SACCHARIN SODIUM Molecular
8. Sodium Benzoate SODIUM BENZOATE Molecular
9. Sodium Citrate, Unspecified Form SODIUM CITRATE, UNSPECIFIED FORM Molecular

Active Ingredients ( 2 Total)

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