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DESCRIPTION
 
Fluoxetine hydrochloride is an antidepressant for oral administration; it is chemically unrelated to tricyclic, tetracyclic, or other available antidepressant agents. It is designated (±)-N-methyl-3-phenyl-3-[(a,a,a-trifluoro-p-tolyl)-oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NO•HCl. Its molecular weight is 345.79.
Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/ml in water.
Each Prozac Pulvule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 mcmol), 20 mg (64.7 mcmol), or 40 mg (129.3 mmol) of fluoxetine. The Pulvules also contain starch, gelatin, silicone, titanium dioxide, iron dioxide, and other inactive ingredients. The 10 mg and 20 mg Pulvules also contain FD&C blue no. 1, and the 40 mg Pulvule also contains FD&C blue no. 1 and FD&C yellow no. 6.
Each Prozac tablet contains fluoxetine HCl equivalent to 10 mg (32.3 mmol) of fluoxetine. The tablets also contain microcrystalline cellulose, magnesium stearate, crospovidone, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and yellow iron oxide. In addition to the above ingredients, the 10 mg tablet contains FD&C blue no. 1 aluminum lake, and polysorbate 80.
The oral solution contains fluoxetine hydrochloride equivalent to 20 mg/5 ml (64.7 mcmol) of fluoxetine. It also contains alcohol 0.23%, benzoic acid, flavoring agent, glycerin, purified water, and sucrose.
 
 

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