Application Nr Approved Date Route Status External Links
ANDA088761 1984-11-08 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Promethazine Hydrochloride And Phenylephrine Hydrochloride Syrup Is Indicated For The Temporary Relief Of Upper Respiratory Symptoms, Including Nasal Congestion, 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. 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. Sodium Benzoate SODIUM BENZOATE Molecular
8. Sodium Citrate, Unspecified Form SODIUM CITRATE, UNSPECIFIED FORM Molecular
9. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.

Active Ingredients ( 2 Total)

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