sevelamer hydrochloride 400 MG Oral Tablet
1. INDICATIONS AND USAGE Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride tablets in CKD patients who are not on dialysis have not been studied. • Sevelamer hydrochloride tablets are a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. ( 1 )
glenmark pharmaceuticals inc., usa
OVAL WHITE G446
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16. HOW SUPPLIED/STORAGE AND HANDLING
SEVELAMER HYDROCHLORIDE Tablets, 400 mg are supplied as off-white to pale yellow, oval shaped, biconvex film-coated tablets, imprinted with ‘G446’ on one side and plain on the other side and are supplied as follows: Bottles of 30 tablets with child-resistant closures: NDC 68462-446-30 Bottles of 360 tablets with child-resistant closures: NDC 68462-446-26
SEVELAMER HYDROCHLORIDE Tablets, 800 mg are supplied as off-white to pale yellow, modified capsule shaped, biconvex film-coated tablets, imprinted with ‘G447’ on one side and plain on the other side and are supplied as follows: Bottles of 30 tablets with child-resistant closures: NDC 68462-447-30 Bottles of 180 tablets with child-resistant closures: NDC 68462-447-18 Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not use
SEVELAMER HYDROCHLORIDE tablets after the expiration date on the bottle. Dispense in a tight container. Protect from moisture and store in a dry place. Keep tablets in original/pharmacy container.
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