tiopronin 300 mg
1 INDICATIONS AND USAGE Tiopronin delayed-release tablets are indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone. Additional pediatric use information is approved for Mission Pharmacal Company’s THIOLA EC (tiopronin) delayed-release tablets. However, due to Mission Pharmacal Company’s marketing exclusivity rights, this drug product is not labeled with that information. Tiopronin delayed-release tablets are a reducing and complexing thiol indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone. (1)
amneal pharmaceuticals ny llc
ROUND WHITE L6
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16 HOW SUPPLIED/STORAGE AND HANDLING
TIOPRONIN Delayed-Release Tablets, 300 mg are supplied as round, white to off-white tablet imprinted with “L6” on one side with red ink and blank on the other side. They are available as follows: Bottles of 90 with child-resistant closure: NDC 60219-2009-9 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep this and all medications out of the reach of children.
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