Application Nr Approved Date Route Status External Links
ANDA040737 2008-04-24 Intramuscular RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Promethazine Hydrochloride Injection Is Indicated For The Following Conditions: 1. Amelioration Of Allergic Reactions To Blood Or Plasma. 2. In Anaphylaxis As An Adjunct To Epinephrine And Other Standard Measures After The Acute Symptoms Have Been Controlled. 3. For Other Uncomplicated Allergic Conditions Of The Immediate Type When Oral Therapy Is Impossible Or Contraindicated. 4. For Sedation And Relief Of Apprehension And To Produce Light Sleep From Which The Patient Can Be Easily Aroused. 5. Active Treatment Of Motion Sickness. 6. Prevention And Control Of Nausea And Vomiting Associated With Certain Types Of Anesthesia And Surgery. 7. As An Adjunct To Analgesics For The Control Of Postoperative Pain. 8. Preoperative, Postoperative, And Obstetric (during Labor) Sedation. 9. Intravenously In Special Surgical Situations, Such As Repeated Bronchoscopy, Ophthalmic Surgery, And Poor-Risk Patients, With Reduced Amounts Of Meperidine Or Other Narcotic Analgesic As An Adjunct To Anesthesia And Analgesia.

All Formulated Excipients (1 Total)

Name Structure Kind Function Status
1. Sodium Chloride SODIUM CHLORIDE Unresolved GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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