SPL Set ID: 3a171942-37af-430d-8b9d-bb678ca2be4b

1 drug(s) with this SPL Set ID

Open DailyMed details

guanfacine GUANFACINE
1 mg Extended-release
ACTAVIS PHARMA, INC. FDA Rx Only

Guanfacine Extended-Release is a once-daily, extended-release formulation of guanfacine hydrochloride (HCl) in a matrix tablet formulation for oral administration only. The chemical designation is N-amidino-2-(2, 6-dichlorophenyl) acetamide monohydrochloride. The chemical structure is: C 9 H 9 Cl 2 N 3 O•HCl M.W. 282.55 Guanfacine hydrochloride, USP is a white to off-white crystalline powder, sparingly soluble in water (approximately 1 mg/mL) and alcohol and slightly soluble in acetone. The only organic solvent in which it has relatively high solubility is methanol (>30 mg/mL). Each tablet contains guanfacine hydrochloride, USP equivalent to 1 mg, 2 mg, 3 mg, or 4 mg of guanfacine base. The tablets also contain colloidal silicon dioxide, crospovidone, fumaric acid, glyceryl behenate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, and povidone. In addition, the 1 mg and 2 mg tablets contain FD&C Yellow #6 Aluminum Lake and the 3 mg and 4 mg tablets contain D&C Yellow #10 Aluminum Lake. The following chemical structure of Guanfacine hydrochloride, USP is a white to off-white crystalline powder, sparingly soluble in water (approximately 1 mg/mL) and alcohol and slightly soluble in acetone. The only organic solvent in which it has relatively high solubility is methanol (greater than 30 mg/mL). Each tablet contains guanfacine hydrochloride, USP equivalent to 1 mg, 2 mg, 3 mg, or 4 mg of guanfacine base.

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