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Setid F638bdb0 D8e9 460d 9dd9 Cf0b35ccdbb2 Applno 18983 Form For Solution Oral Dosage 227 1gm Packet 2 82gm Packet 6 36gm Packet 5 53gm Packet 21 5gm Packet - Drug Product Composition: PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE; BISACODYL-4

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USFDA APPLICATION NUMBER - 18983 / DOSAGE - FOR SOLUTION;ORAL - 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
(POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)
POLYETHYLENE GLYCOL 3350240g in 4
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
(POTASSIUM CATION - UNII:295O53K152)
POTASSIUM CHLORIDE2.98g in 4
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
(SODIUM CATION - UNII:LYR4M0NH37)
SODIUM BICARBONATE6.72g in 4
SODIUM CHLORIDE(UNII: 451W47IQ8X)
(SODIUM CATION - UNII:LYR4M0NH37)
SODIUM CHLORIDE5.84g in 4
SODIUM SULFATE(UNII: 0YPR65R21J)
(SODIUM CATION - UNII:LYR4M0NH37)
SODIUM SULFATE22.72g in 4