Application Nr Approved Date Route Status External Links
ANDA090575 2011-02-08 Oral DISCN Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & 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 (9 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. Edetate Disodium EDETATE DISODIUM Molecular
4. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
5. Methylparaben METHYLPARABEN 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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