24 HR Propranolol Hydrochloride 160 MG Extended Release Oral Capsule
INDICATIONS AND USAGE Hypertension: Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules are not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis: Propranolol hydrochloride extended-release capsules are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Migraine: Propranolol hydrochloride extended-release capsules are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Hypertrophic Subaortic Stenosis: Propranolol hydrochloride extended-release capsules improve NYHA functional class in symptomatic patients with Hypertrophic Subaortic Stenosis.
Zydus Pharmaceuticals (USA) Inc.
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HOW SUPPLIED
PROPRANOLOL HYDROCHLORIDE Extended-release capsules USP, 60 mg are white to off-white, free flowing pellets filled in size '3' hard gelatin capsules with white colored cap printed with "ZA-57" in black ink and light blue body printed with "60 mg" in black ink and are supplied as follows: NDC 68382-161-16 in bottle of 90 capsules NDC 68382-161-01 in bottle of 100 capsules NDC 68382-161-05 in bottle of 500 capsules NDC 68382-161-10 in bottle of 1000 capsules NDC 68382-161-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules
PROPRANOLOL HYDROCHLORIDE Extended-release capsules USP, 80 mg are white to off-white, free flowing pellets filled in size '3' hard gelatin capsules with light blue colored cap printed with "ZA-58" in black ink and light blue body printed with "80 mg" in black ink and are supplied as follows: NDC 68382-162-16 in bottle of 90 capsules NDC 68382-162-01 in bottle of 100 capsules NDC 68382-162-05 in bottle of 500 capsules NDC 68382-162-10 in bottle of 1000 capsules NDC 68382-162-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules
PROPRANOLOL HYDROCHLORIDE Extended-release capsules USP, 120 mg are white to off- white, free flowing pellets filled in size'2' hard gelatin capsules with dark blue colored cap printed with "ZA-59" in black ink and light blue body printed with "120 mg" in black ink and are supplied as follows: NDC 68382-163-16 in bottle of 90 capsules NDC 68382-163-01 in bottle of 100 capsules NDC 68382-163-05 in bottle of 500 capsules NDC 68382-163-10 in bottle of 1000 capsules NDC 68382-163-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules
PROPRANOLOL HYDROCHLORIDE Extended-release capsules USP, 160 mg are white to off- white, free flowing pellets filled in size '1' hard gelatin capsules with dark blue colored cap printed with "ZA-60" in black ink and dark blue body printed with "160 mg" in black ink and are supplied as follows: NDC 68382-164-16 in bottle of 90 capsules NDC 68382-164-01 in bottle of 100 capsules NDC 68382-164-05 in bottle of 500 capsules NDC 68382-164-10 in bottle of 1000 capsules NDC 68382-164-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light, moisture, freezing, and excessive heat. Dispense in a tight, light-resistant container. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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