phentermine hydrochloride tablet
1 INDICATIONS AND 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 ≥ 30 kg/m2, or ≥ 27 kg/m2 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 tablets, USP [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 ≥ 30 kg/m2, or ≥ 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 tablets, USP, should be measured against possible risk factors inherent in their use. ( 1 ) Image of the Body Mass Index Chart
solco healthcare u.s., llc
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16 HOW SUPPLIED/STORAGE AND HANDLING Available in tablets containing 37.5 mg
PHENTERMINE HYDROCHLORIDE (equivalent to 30 mg phentermine base). Each
PHENTERMINE HYDROCHLORIDE tablet for oral administration is white with blue specks, capsule shaped, bisected and debossed “5030” on one side and debossed “V” on the reverse side. Tablets are packaged in bottles of 30 (NDC 43547-404-03), 100 (NDC 43547-404-10) and 1000 (NDC 43547-404-11). You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Keep out of the reach of children.
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