Bontril PDM (Phendimetrazine Tartrate) - Indications and Dosage

INDICATIONS AND USAGE

Bontril^® PDM (phendimetrazine tartrate) is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.

DOSAGE AND ADMINISTRATION

Usual Adult Dosage: 1 tablet (35 mg) b.i.d. or t.i.d., one hour before meals.

Dosage should be individualized to obtain an adequate response with the lowest effective dosage. In some cases, ½ tablet (17.5 mg) per dose may be adequate. Dosage should not exceed 2 tablets t.i.d.

HOW SUPPLIED

Three-layered green, white and yellow tablet with “B 35” on the scored side and the letter “V” on the other. Bontril^® PDM tablets containing 35 mg of phendimetrazine tartrate are available in bottles of 100 (NDC 0187-0497-01) and 1000 (NDC 0187-0497-02).

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F).

Manufactured for
Valeant Pharmaceuticals International
3300 Hyland Ave.
Costa Mesa, CA 92626 U.S.A.
Manufactured by
Mallinckrodt, Inc.
Hobart, NY 13788

Part No. L2BB01