duloxetine 30 MG Delayed Release Oral Capsule
1 INDICATIONS AND USAGE Duloxetine delayed-release capsules are indicated for the treatment of: Major Depressive disorder in adults Generalized Anxiety disorder in adults and pediatric patients 7 years of age and older Diabetic peripheral neuropathic pain in adults Fibromyalgia in adults Chronic Musculoskeletal Pain in adults Additional pediatric use information is approved for Eli Lilly and Company, Inc.'s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Duloxetine delayed-release capsule is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: Major Depressive disorder (MDD) in adults (1) Generalized Anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1) Diabetic peripheral neuropathic pain (DPNP) in adults (1) Fibromyalgia (FM) in adults (1) Chronic Musculoskeletal Pain in adults (1)
American Health Packaging
CAPSULE LU Q02
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Duloxetine is available as delayed-release capsules in the following strengths, colors, imprints, and presentations: Features Strengths 20 mg equivalent to duloxetine base 30 mg 60 mg Body color green white green Cap color green Dark blue Dark blue Cap imprint ‘LU’ ‘LU’ ‘LU’ Body imprint ‘Q01’ ‘Q02’ ‘Q03’ capsule number 4 3 1 20 mg supplied in unit dose packages of 30 (3 x 10) NDC 68084-675-21 30 mg supplied in unit dose packages of 100 (10 x 10) NDC 68084-683-01 60 mg supplied in unit dose packages of 100 (10 x 10) NDC 68084-692-01 16.2 Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
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