Label: PHENTERMINE HYDROCHLORIDE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 51655-875-24, 51655-875-25, 51655-875-90 - Packager: Northwind Pharmaceuticals
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: CIV
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 20, 2014
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- Official Label (Printer Friendly)
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PRINCIPAL DISPLAY PANEL
NDC: 51655-875-25
MFG: 53489-676-10
Phentermine HCL 37.5 MG C IV
60 tablets
Rx only
Lot#:
Exp. Date:
Each tablet contains: Phentermine hydrochloride, USP....37.5mg
Dosage: See package insert
Store at 68 to 77 degrees F.
Store in a tight, light-resistance container (See USP) Keep out of the reach of children.
Mfg by: Mutual Pharmaceuticals Co., Inc Philadelphia, PA 19124 Lot #
Distributed by: Northwind Pharmaceuticals, Indianapolis, IN 46256
NDC: 51655-875-90
Phentermine HCL 37.5 MG C IV
45 Tablets Rx Only
Lot: Exp:
Store at 20C to 25C (68-77F)
Manufactured by Mutual Pharmaceuticals Co Inc
Manufacture Address: Philadelphia, PA 19124
Manufacture NDC: 53489-676-10 Mfg Lot: 6677501
Distributed by: Northwind Pharmaceuticals Indianapolis, IN 46256
NDC: 51655-875-24
Phentermine HCL 37.5 MG C IV
30 Tablets Rx Only
Lot: Exp:
Store at 20C to 25C (68-77F)
Manufactured by Mutual Pharmaceuticals Co Inc
Manufacture Address: Philadelphia, PA 19124
Manufacture NDC: 53489-676-10 Mfg Lot: 6677501
Distributed by: Northwind Pharmaceuticals Indianapolis, IN 46256
NDC: 51655-875-25
Phentermine HCL 37.5 MG C IV
60 Tablets Rx Only
Lot: Exp:
Store at 20C to 25C (68-77F)
Manufactured by Mutual Pharmaceuticals Co Inc
Manufacture Address: Philadelphia, PA 19124
Manufacture NDC: 53489-676-10 Mfg Lot: 6677501
Distributed by: Northwind Pharmaceuticals Indianapolis, IN 46256
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Indications and Usage
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, should be measured against possible risk factors inherent in their use
- Dosage and Administration
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Contraindications
History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) During or within 14 days following the administration of monoamine oxidase inhibitors
Hyperthyroidism
Glaucoma
Agitated states
History of drug abuse
Pregnancy
Nursing
Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines
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Warning and Precautions
Coadministration with other drugs for weight loss is not recommended (safety and efficacy of combination not established). Rare cases of primary pulmonary hypertension have been reported. Phentermine should be discontinued in case of new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema. Rare cases of serious regurgitant cardiac valvular disease have been reported. Tolerance to the anorectic effect usually develops within a few weeks. If this occurs, phentermine should be discontinued. The recommended dose should not be exceeded. Phentermine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle. Risk of abuse and dependence. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Concomitant alcohol use may result in an adverse drug reaction. Use caution in patients with even mild hypertension (risk of increase in blood pressure). A reduction in dose of insulin or oral hypoglycemic medication may be required in some patients.
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INGREDIENTS AND APPEARANCE
PHENTERMINE HYDROCHLORIDE
phentermine hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-875(NDC:53489-676) Route of Administration ORAL DEA Schedule CIV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENTERMINE HYDROCHLORIDE (UNII: 0K2I505OTV) (PHENTERMINE - UNII:C045TQL4WP) PHENTERMINE 37.5 mg Product Characteristics Color white Score 2 pieces Shape OVAL Size 13mm Flavor Imprint Code MP;273 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51655-875-25 60 in 1 BOTTLE, DISPENSING 2 NDC:51655-875-90 45 in 1 BOTTLE, DISPENSING 3 NDC:51655-875-24 30 in 1 BOTTLE, DISPENSING Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040526 05/15/2014 Labeler - Northwind Pharmaceuticals (036986393) Registrant - Northwind Pharmaceuticals (036986393) Establishment Name Address ID/FEI Business Operations Northwind Pharmaceuticals 036986393 repack(51655-875)