"In a drug safety communication issued today, the US Food and Drug Administration (FDA) says it is aware of recent reports "questioning" the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy, but that it l"...
DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets are round, white, film-coated, delayed-release tablets containing 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman.
Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue#2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.
Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N -dimethyl-2-[1phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O • C4H6O4 and the molecular mass is 388.46. The structural formula is:
Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6methyl-, hydrochloride. The empirical formula is C8H11NO3 •HCl and the molecular mass is 205.64. The structural formula is:
Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.
Last reviewed on RxList: 10/11/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Diclegis Information
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