Quinine Sulfate 324 MG Oral Capsule
1 INDICATIONS AND USAGE Quinine sulfate capsules are an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14) ] . Quinine sulfate oral capsules are not approved for: • Treatment of severe or complicated P. falciparum malaria. • Prevention of malaria. • Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1) ] . Quinine sulfate is a cinchona alkaloid indicated for treatment of uncomplicated Plasmodium falciparum malaria. ( 1 )
Mylan Pharmaceuticals Inc.
CAPSULE WHITE Mylan QS 324
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Quinine Sulfate capsules, USP are available containing 324 mg of quinine sulfate, USP. The 324 mg capsule is a buff opaque cap and buff opaque body, hard-shell gelatin capsule filled with white to off-white powder. The capsule is axially printed with MYLAN over QS 324 in black ink on cap and body. They are available as follows: NDC 0378-7180-93 bottles of 30 capsules 16.2 Storage 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 using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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