INDICATIONS AND USAGE 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.

ADVERSE REACTIONS Central Nervous System Drowsiness is the most prominent CNS effect of this drug.

Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria.

Hallucinations have also been reported.

Cardiovascular – Increased or decreased blood pressure, tachycardia, bradycardia, faintness.

Dermatologic – Dermatitis, photosensitivity, urticaria.

Hematologic – Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.

Gastrointestinal – Dry mouth, nausea, vomiting, jaundice.

Respiratory – Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal).

(See WARNINGS–Respiratory Depression ).

Other – Angioneurotic edema.

Neuroleptic malignant syndrome (potentially fatal) has also been reported (See WARNINGS–Neuroleptic Malignant Syndrome ).

Paradoxical Reactions Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCl.

Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur.

Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients.

To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc.

at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.