phentermine hydrochloride capsule
1 INDICATIONS AND USAGE Phentermine hydrochloride capsules 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 ≥ 30 kg/m 2 , or ≥ 27 kg/m 2 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 ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m 2 The limited usefulness of agents of this class, including phentermine, [se e CLINICAL PHARMACOLOGY ( 12.1 , 12.2 )] should be measured against possible risk factors inherent in their use such as those described below. Phentermine hydrochloride is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) 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 ≥ 30 kg/m 2 , or ≥ 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use.
sunrise pharmaceutical, inc.
CAPSULE BLUE N16
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phentermine hydrochloride capsule
sunrise pharmaceutical, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
PHENTERMINE HYDROCHLORIDE capsules USP, for oral administration, are available as: 15 mg: grey/yellow powder filled capsules; imprinted “N1” in black ink and supplied as: NDC 11534-157-01 bottles of 100 NDC 11534-157-03 bottles of 1,000 30 mg : blue/Clear powder filled capsules; imprinted “N16” in black ink and supplied as: NDC 11534-176-01 bottles of 100 NDC 11534-176-03 bottles of 1,000 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep out of the reach of children.
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