FDA label

What is promethazine used for?

The FDA-approved uses of promethazine, 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 hydrochloride tablet is useful for: Perennial and seasonal allergic rhinitis.”

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Promethazine Hydrochloride, tablet

Indications and Usage, quoted from the label by KVK-Tech, Inc. (ANDA040712). Cross-references to other label sections are left out.

Promethazine hydrochloride tablet 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.

Source: DailyMed label, set id 7a137adf-39b7-4b14-80da-c3cac9ad562a, version 13, effective March 13, 2026. NDC 10702-002, one of 79 listings for this product.

Promethazine Hydrochloride, injection

Indications and Usage, quoted from the label by ProPharma Distribution (ANDA083312). Cross-references to other label sections are left out.

Promethazine hydrochloride injection is indicated for the following conditions:

  • Amelioration of allergic reactions to blood or plasma.
  • In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled.
  • For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.
  • For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused.
  • Active treatment of motion sickness.
  • Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
  • As an adjunct to analgesics for the control of postoperative pain.
  • Preoperative, postoperative, and obstetric (during labor) sedation.
  • 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.

Source: DailyMed label, set id 38673af1-112e-9ddd-e063-6294a90af465, version 3, effective December 18, 2025. NDC 84549-928, one of 23 listings for this product.

Promethazine Hydrochloride, 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 12 listings for this product.

Questions

What is promethazine used for?

The FDA label says: “Promethazine hydrochloride tablet is useful for: Perennial and seasonal allergic rhinitis.”

What drug class is promethazine?

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.

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