Quinine Sulfate 324 MG Oral Capsule
1 INDICATIONS AND USAGE Quinine sulfate is 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) ] . Limitations of Use: Quinine sulfate 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 an antimalarial indicated for treatment of uncomplicated Plasmodium falciparum malaria. (1) Limitations of Use: Quinine sulfate capsules are not approved for: Treatment of severe or complicated P. falciparum malaria. Prevention of malaria. Treatment or prevention of nocturnal leg cramps
Amneal Pharmaceuticals LLC
CAPSULE WHITE AMNEAL 811
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied
QUININE Sulfate capsules USP, 324 mg are clear transparent size ‘0’ hard gelatin capsules filled with white to off-white powder and imprinting ‘AMNEAL’ on the cap and ‘811’ on the body. They are available as follows: Bottles of 30: NDC 65162-811-03 Bottles of 90: NDC 65162-811-09 Bottles of 500: NDC 65162-811-50 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.
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