Doxepin Hydrochloride 25 MG Oral Capsule
INDICATIONS AND USAGE Doxepin hydrochloride capsules are recommended for the treatment of: 1. Psychoneurotic patients with depression and/or anxiety. 2. depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). 3. depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). 4. Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that doxepin hydrochloride capsules are safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin hydrochloride capsules are not recommended for use in children under 12 years of age.
Aurobindo Pharma Limited
CAPSULE YELLOW DOX 25
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HOW SUPPLIED
DOXEPIN HYDROCHLORIDE capsules, USP are available containing
DOXEPIN HYDROCHLORIDE, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg or 100 mg of Doxepin.
DOXEPIN HYDROCHLORIDE capsules USP, 10 mg are buff colored size “4” hard gelatin capsule filled with white to off-white granules and imprinted with DOX on cap and 10 on body. Bottles of 100 NDC 59651-173-01
DOXEPIN HYDROCHLORIDE capsules USP, 25 mg are ivory and white colored size “3” hard gelatin capsule filled with white to off-white granules and imprinted with DOX on cap and 25 on body. Bottles of 100 NDC 59651-174-01
DOXEPIN HYDROCHLORIDE capsules USP, 50 mg are ivory colored size “3” hard gelatin capsule filled with white to off-white granules and imprinted with DOX on cap and 50 on body. Bottles of 100 NDC 59651-175-01
DOXEPIN HYDROCHLORIDE capsules USP, 75 mg are brite lite green colored size “2” hard gelatin capsule filled with white to off-white granules and imprinted with DOX on cap and 75 on body. Bottles of 100 NDC 59651-176-01
DOXEPIN HYDROCHLORIDE capsules USP, 100 mg are brite lite green and white colored size “1” hard gelatin capsule filled with white to off-white granules and imprinted with DOX on cap and 100 on body. Bottles of 100 NDC 59651-177-01 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 038, India Issued: December 2018
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