SPL Set ID: defc1205-8e90-4b1e-b862-05e4c35c7364

1 drug(s) with this SPL Set ID

Open DailyMed details

QuilliChew ER METHYLPHENIDATE HYDROCHLORIDE
NEXTWAVE PHARMACEUTICALS, INC FDA Rx Only

QuilliChew ER (methylphenidate hydrochloride extended-release chewable tablets) is available in three dosage strengths - 20 mg, 30 mg and 40 mg. The dosage strengths are expressed in terms of methylphenidate hydrochloride equivalents; however only 15% of methylphenidate is present as methylphenidate hydrochloride salt. The remaining 85% is present as methylphenidate ionically-bound to the sulfonate groups of sodium polystyrene sulfonate particles. QuilliChew ER contains approximately 30% immediate-release and 70% extended-release methylphenidate. The QuilliChew ER extended-release chewable tablets are cherry flavored. Methylphenidate HCl is a central nervous system (CNS) stimulant. The chemical name is methyl α- phenyl-2-piperidineacetate hydrochloride, and its structural formula is shown in Figure 1. Figure 1: Methylphenidate HCl Structure Methylphenidate HCl is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. QuilliChew ER also contains the following inactive ingredients: aspartame [see Warnings and Precautions ( 5.8 ) ] , cherry flavor, citric acid, crospovidone, D&C red #30 (for 30 mg strength), D&C red #7 (for 40 mg strength), guar gum, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl acetate, polyvinyl alcohol, povidone, silicon dioxide, sodium polystyrene sulfonate, talc, triacetin, xanthan gum. structure

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