pregabalin 200 MG Oral Capsule
1 INDICATIONS AND USAGE Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury Pediatric use information is approved for Pfizer’s LYRICA ® (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Pregabalin is indicated for: neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( 1 ) Postherpetic neuralgia (PHN) ( 1 ) Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older ( 1 ) fibromyalgia ( 1 ) neuropathic pain associated with spinal cord injury ( 1 )
teva pharmaceuticals usa, inc.
CAPSULE ORANGE Teva 7627
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16 HOW SUPPLIED/STORAGE AND HANDLING Pregabalin capsules are available as follows: 75 mg – Hard gelatin capsules with a buff opaque body and pink opaque cap, filled with a white to off-white powder with small agglomerates, imprinted with “TEVA” and “7624” on the body and cap, in bottles of 90 (NDC 0093-7624-98). 100 mg – Hard gelatin capsules with a pink opaque body and cap, filled with a white to off-white powder with small agglomerates, imprinted with “TEVA” and “7625” on the body and cap, in bottles of 90 (NDC 0093-7625-98). 150 mg – Hard gelatin capsules with a white opaque body and cap, filled with a white to off-white powder with small agglomerates, imprinted with “TEVA” and “7626” on the body and cap, in bottles of 90 (NDC 0093-7626-98). 200 mg – Hard gelatin capsules with a light-orange opaque body and cap, filled with a white to off-white powder with small agglomerates, imprinted with “TEVA” and “7627” on the body and cap, in bottles of 90 (NDC 0093-7627-98). 225 mg – Hard gelatin capsules with a white opaque body and light-orange opaque cap, filled with a white to off-white powder with small agglomerates, imprinted with “TEVA” and “7628” on the body and cap, in bottles of 90 (NDC 0093-7628-98). 300 mg – Hard gelatin capsules with a buff opaque body and pink opaque cap, filled with a white to off-white powder with small agglomerates, imprinted with “TEVA” and “7621” on the body and cap, in bottles of 90 (NDC 0093-7621-98). Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
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