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prochlorperazine 5 mg

INDICATIONS AND USAGE For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine maleate tablets are effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine maleate tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine maleate tablets should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine maleate tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS ). The effectiveness of prochlorperazine maleate tablets as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine maleate tablets will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Prochlorperazine maleate tablets have not been shown effective in the management of behavioral complications in patients with mental retardation.

amneal pharmaceuticals ny llc


11 months ago ROUND YELLOW J 5 prochlorperazine 5 mg

ROUND YELLOW J 5

HOW SUPPLIED

PROCHLORPERAZINE MALEATE Tablets USP, 5 mg are supplied as yellow, round, film-coated tablet debossed with “J” on the top and “5” on the bottom of the score line on one side and plain on the other side. They are available as follows: Bottles of 100 with child-resistant closure: NDC 60219-2038-1 Bottles of 1,000: NDC 60219-2038-7

PROCHLORPERAZINE MALEATE Tablets USP, 10 mg are supplied as yellow, round, film-coated tablet debossed with “J” on the top and “7” on the bottom of the score line on one side and plain on the other side. They are available as follows: Bottles of 100 with child-resistant closure: NDC 60219-2039-1 Bottles of 1,000: NDC 60219-2039-7 Store at 20° to 25°C (68° to 77°F) ; excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Keep container tightly closed. Important: Use safety closure when dispensing this product unless otherwise directed by physician or requested by purchaser. Dispense in tight, light-resistant container. Keep this and all medications out of the reach of children. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . All trademarks are the property of their respective owners. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 01-2023-02


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