FDA Label for Phentermine Hydrochloride
View Indications, Usage & Precautions
Phentermine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product H.j. Harkins Company, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Indications & Usage
Phentermine hydrochloride tablets USP are indicated as a short-term (a few weeks) adjunct in a regimen
of weight reduction based on exercise, behavioral modification and caloric restriction in the
management of exogenous obesity for patients with an initial body mass index greater than or equal to
30 kg/m , or greater than or equal to 27 kg/m in the presence of other risk factors (e.g., controlled
hypertension, diabetes, hyperlipidemia).
Below is a chart of body mass index (BMI) based on various heights and weights.
BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds รท 2.2 = kg; inches x 0.0254 = meters.
Description
Phentermine hydrochloride USP is a sympathomimetic amine anorectic. Its chemical name is a,a- dimethylphenethylamine hydrochloride. The structural formula is as follows:
Phentermine hydrochloride USP is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether.
Phentermine hydrochloride tablets USP are available as an oral tablet containing 37.5 mg of phentermine hydrochloride USP (equivalent to 30 mg of phentermine base). Each phentermine hydrochloride tablet USP also contains the inactive ingredients microcrystalline cellulose, pregelatinized starch, anhydrous lactose, crospovidone, colloidal silicon dioxide, magnesium stearate, sucrose, corn starch and FD&C Blue #1.
Package And Display
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