Phentermine Hydrochloride 30 MG Oral Capsule
1 INDICATIONS AND USAGE Phentermine Hydrochloride, USP 15 mg and 30 mg is 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 2 , or greater than or equal to 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. The limited usefulness of agents of this class, including Phentermine hydrochloride, [ see 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 greater than or equal to 30 kg/m 2 , or greater than or equal to 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). ( 1 ) The limited usefulness of agents of this class, including Phentermine hydrochloride, should be measured against possible risk factors inherent in their use. ( 1 ) BMI
KVK-Tech, Inc.
CAPSULE YELLOW K 27
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16 HOW SUPPLIED/STORAGE AND HANDLING
PHENTERMINE HYDROCHLORIDE capsules, USP are available as follows:
PHENTERMINE HYDROCHLORIDE capsules, USP 15 mg are supplied as gray opaque cap, rich yellow opaque body with black imprint “K 26” on both the cap and body, filled with powder. Bottles of 30, NDC 10702-026-03 Bottles of 100, NDC 10702-026-01 Bottles of 1000, NDC 10702-026-10
PHENTERMINE HYDROCHLORIDE capsules, USP 30 mg are supplied as rich yellow opaque cap, rich yellow opaque body with black imprint “K 27” on both the cap and body, filled with powder. Bottles of 30, NDC 10702-027-03 Bottles of 100, NDC 10702-027-01 Bottles of 1000, NDC 10702-027-10
PHENTERMINE HYDROCHLORIDE capsules, USP 30 mg are supplied as blue cap, natural body with black imprint “K 28” on both the cap and body, filled with white and blue colored beads. Bottles of 30, NDC 10702-028-03 Bottles of 100, NDC 10702-028-01 Bottles of 1000, NDC 10702-028-10 Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. 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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