Meprobamate (Meprobamate) - Indications and Dosage

INDICATIONS AND USAGE

Meprobamate tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually do not require treatment with an anxiolytic.

The effectiveness of meprobamate tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.

DOSAGE AND ADMINISTRATION

Meprobamate Tablets USP: The usual adult daily dosage is 1200 mg to 1600 mg, in three or four divided doses; a daily dosage above 2400 mg is not recommended. The usual daily dosage for children ages six to twelve years is 200 mg to 600 mg, in two or three divided doses. Not recommended for children under age 6 (see Usage in Children ).

HOW SUPPLIED

Meprobamate Tablets USP 200 mg are white to off white, round, biconvex, uncoated tablets debossed with "L125" on one side and break line on other side.

NDC 23155- 128 -03               Bottle of 30

NDC 23155- 128 -01               Bottle of 100

NDC 23155- 128 -10               Bottle of 1000

Meprobamate Tablets USP 400 mg are white to off white, round, biconvex, uncoated tablets debossed with "L105" on one side and break line on other side.

NDC 23155- 129 -03               Bottle of 30

NDC 23155- 129 -01               Bottle of 100

NDC 23155- 129 -10               Bottle of 1000

Dispense in well-closed container with child-resistant closure.

Store at controlled room temperature, excursions permitted to 15°C-30°C (59°F-86°F).

Preserve in well closed container.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

Manufactured for:
Heritage Pharmaceuticals Inc.
Edison, NJ 08837
1.866.901.DRUG (3784)

Manufactured by:
Alembic Limited (Formulation Division),
Village Panelav, P. O. Tajpura, Near Baska,
Taluka-Halol, Panchmahal, Gujarat, India

Revision Date: April 2009