Phenytoin Sodium Phenytoin sodium 100 MG Extended Release Oral Capsule

1 INDICATIONS AND USAGE Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. ( 1 )

Mylan Pharmaceuticals Inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] adverse drug reaction` `[3] toxicity to various agents` `[4] completed suicide` `[5] drug abuse` `[6] overdose` `[7] drug dependence` `[8] off label use` `[9] application site pruritus` `[10] pain`

9 years ago

CAPSULE PURPLE Mylan 1560

9 years ago

Mylan 1560 CAPSULE PURPLE

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Extended Phenytoin Sodium capsules, USP are available containing 100 mg of phenytoin sodium, USP. The 100 mg capsules are hard-shell gelatin capsules with a light Lavender opaque cap and white opaque body filled with one white to off-white capsule-shaped tablet. The capsules are axially printed with MYLAN over 1560 in black ink on both the cap and body. They are available as follows: NDC 0378-1560-01 bottles of 100 capsules NDC 0378-1560-10 bottles of 1000 capsules 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

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Phenytoin Sodium Phenytoin sodium 100 MG Extended Release Oral Capsule

FDA Reported Adverse Reactions [1] drug ineffective [2] adverse drug reaction [3] toxicity to various agents [4] completed suicide [5] drug abuse [6] overdose [7] drug dependence [8] off label use [9] application site pruritus [10] pain

CAPSULE PURPLE Mylan 1560

Mylan 1560 CAPSULE PURPLE

More pills like CAPSULE Mylan 1560

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] adverse drug reaction` `[3] toxicity to various agents` `[4] completed suicide` `[5] drug abuse` `[6] overdose` `[7] drug dependence` `[8] off label use` `[9] application site pruritus` `[10] pain`