phentermine phentermine hydrochloride capsule
1 INDICATIONS & 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 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. BODY MASS INDEX (BMI), kg/m 2 Height ( fe et , inches) Weight (pounds) 5’0” 5’3” 5’6” 5’9” 6’0” 6’3” 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31 The limited usefulness of agents of this class, including phentermine, [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/m2, or greater than or equal to 27 kg/m2 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 Capsules USP, should be measured against possible risk factors inherent in their use. ( 1 )
aurolife pharma, llc
CAPSULE YELLOW U47
U47 CAPSULE YELLOW
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phentermine phentermine hydrochloride capsule
aurolife pharma, llc
phentermine phentermine hydrochloride capsule
aurolife pharma, llc
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16 HOW SUPPLIED/STORAGE AND HANDLING
PHENTERMINE HYDROCHLORIDE capsules USP, 15 mg are white to off-white powder filled in Size ‘3’ gray opaque/yellow opaque capsules, imprinted with “U47” on cap and body in black ink. Bottles of 30 NDC 13107-105-30 Bottles of 100 NDC 13107-105-01
PHENTERMINE HYDROCHLORIDE capsules USP, 30 mg are white to off-white powder filled in Size ‘3’ yellow opaque/yellow opaque capsules, imprinted with “U48” on cap and body in black ink. Bottles of 30 NDC 13107-106-30 Bottles of 100 NDC 13107-106-01 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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