PHENTERMINE HYDROCHLORIDE tablet

Phentermine hydrochloride by

Drug Labeling and Warnings

Phentermine hydrochloride by is a Prescription medication manufactured, distributed, or labeled by Northwind Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Dosage should be individualized to obtain an adequate response with the lowest effective dose.

Late evening administration should be avoided (risk of insomnia).

Phentermine hydrochloride tablets can be taken with or without food

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

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.

INGREDIENTS AND APPEARANCE

PHENTERMINE HYDROCHLORIDE 
phentermine hydrochloride tablet

Product 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)