Label: PHENTERMINE HYDROCHLORIDE tablet

  • 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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  • 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

    Phentermine HCL 51655-875

    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

    51655-875-90

    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

    51655-875-24

    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

    51655-875-25

  • 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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-875(NDC:53489-676)
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENTERMINE HYDROCHLORIDE (UNII: 0K2I505OTV) (PHENTERMINE - UNII:C045TQL4WP) PHENTERMINE37.5 mg
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize13mm
    FlavorImprint Code MP;273
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51655-875-2560 in 1 BOTTLE, DISPENSING
    2NDC:51655-875-9045 in 1 BOTTLE, DISPENSING
    3NDC:51655-875-2430 in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04052605/15/2014
    Labeler - Northwind Pharmaceuticals (036986393)
    Registrant - Northwind Pharmaceuticals (036986393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwind Pharmaceuticals036986393repack(51655-875)