Application Nr Approved Date Route Status External Links
ANDA040643 2006-04-26 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Promethazine Is Useful For: Perennial And Seasonal Allergic Rhinitis. Vasomotor Rhinitis. Allergic Conjunctivitis Due To Inhalant Allergens And Foods. Mild, Uncomplicated Allergic Skin Manifestations Of Urticaria And Angioedema. Amelioration Of Allergic Reactions To Blood Or Plasma. Dermographism. Anaphylactic Reactions, As Adjunctive Therapy To Epinephrine And Other Standard Measures, After The Acute Manifestations Have Been Controlled. Preoperative, Postoperative, Or Obstetric Sedation. Prevention And Control Of Nausea And Vomiting Associated With Certain Types Of Anesthesia And Surgery. Therapy Adjunctive To Meperidine Or Other Analgesics For Control Of Postoperative Pain. Sedation In Both Children And Adults, As Well As Relief Of Apprehension And Production Of Light Sleep From Which The Patient Can Be Easily Aroused. Active And Prophylactic Treatment Of Motion Sickness. Antiemetic Therapy In Postoperative Patients.

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. Saccharin Sodium SACCHARIN SODIUM Molecular
8. Sodium Benzoate SODIUM BENZOATE Molecular
9. Sodium Citrate, Unspecified Form SODIUM CITRATE, UNSPECIFIED FORM Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE ZINC20250

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