Application Nr Approved Date Route Status External Links
ANDA040675 2014-12-23 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 (8 Total)

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

Active Ingredients ( 2 Total)

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