SPL Set ID: 957865a2-efcf-43a6-92a8-f9f980892833

1 drug(s) with this SPL Set ID

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Doxylamine Succinate and Pyridoxine Hydrochloride DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
MYLAN PHARMACEUTICALS INC. FDA Rx Only

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are round, white to off-white, film-coated, delayed-release tablets containing 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride. Tablets are imprinted with M over DP in black ink on one side of the tablet and blank on the other side. Inactive ingredients are as follows: hypromellose, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol and talc. In addition, the black imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. Doxylamine Succinate: Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is 2-[α[2-(Dimethylamino)ethoxy]-α-methylbenzyl]pyridine succinate (1:1). The molecular formula is C 17 H 22 N 2 O • C 4 H 6 O 4 and the molecular mass is 388.46. The structural formula is: Doxylamine succinate, USP is a white or almost white powder, having a characteristic odor, that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride: Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-Pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The molecular formula is C 8 H 12 ClNO 3 and the molecular mass is 205.6. The structural formula is: Pyridoxine hydrochloride, USP is white or practically white crystals or crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether. Doxylamine Succinate Structural Formula Pyridoxine Hydrochloride Structural Formula

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