Application Nr Approved Date Route Status External Links
ANDA040649 2006-02-14 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral Solution Is Indicated For The Temporary Relief Of Coughs And Upper Respiratory Symptoms Associated With Allergy Or The Common Cold.

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Ascorbic Acid ASCORBIC ACID Molecular DS-Dietary supplement , MISC-Miscellaneous , NUTR-Nutrient , PRES-Chemical preservative FS-Substances permitted as optional ingredient in a standardized food.
2. Citric Acid Monohydrate CITRIC ACID MONOHYDRATE Molecular
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

Active Ingredients ( 2 Total)

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