Application Nr Approved Date Route Status External Links
ANDA087953 1982-11-15 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 Post-Operative 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 (3 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. Anhydrous Citric Acid ANHYDROUS CITRIC ACID Molecular
3. Alcohol ALCOHOL Molecular

Active Ingredients ( 1 Total)

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

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