FDA label
What is Promethegan used for?
Promethegan contains promethazine. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Promethazine HCl Suppositories, USP are 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 sta...”
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Promethegan, suppository
Indications and Usage, quoted from the label by Cosette Pharmaceuticals, Inc. (ANDA087165). Cross-references to other label sections are left out.
Promethazine HCl Suppositories, USP are 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.
Source: DailyMed label, set id 636bb9bc-0cc5-4d6a-85be-6471acf01ffc, version 7, effective November 30, 2023. NDC 0713-0132, one of 4 listings for this product.
Questions
What is Promethegan used for?
The FDA label says: “Promethazine HCl Suppositories, USP are 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 sta...”
What drug class is Promethegan?
FDA lists promethazine in the Phenothiazine established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Promethegan
- Is Promethegan a controlled substance?Federal schedule
- What is Promethazine used for?FDA label uses
- Is Promethazine a controlled substance?Federal schedule
- Generic for PhenerganFDA Orange Book
- Phenothiazines listFDA drug class
- NDC 0713-0132Promethegan NDC record
- NDC 0713-0526Promethegan NDC record
- NDC 0713-0536Promethegan NDC record