Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.

Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults ( 1).

• Recommended dosage: 25 mg to 100 mg daily, in divided doses ( 2.1).
• Tablets: Swallow whole ( 2.2).

The recommended dosage is 25 mg to 100 mg daily administered orally, in divided doses, depending upon clinical response.

Meclizine hydrochloride tablets must be swallowed whole.

Meclizine hydrochloride tablets are contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see Adverse Reactions ( 6) and Description ( 11)].

Meclizine hydrochloride tablets are contraindicated in patients with hypersensitivity to meclizine or any of the inactive ingredients ( 4).

•   May cause drowsiness: Use caution when driving a car or operating dangerous machinery ( 5.1).
•   Potential anticholinergic action: this drug should be prescribed with care to patients with a history of asthma, glaucoma, or enlargement of the prostate gland ( 5.2).

Since drowsiness may occur with use of meclizine hydrochloride, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery.

Patients should avoid alcoholic beverages while taking meclizine hydrochloride   [see Drug Interactions ( 7.1)].

Because of its potential anticholinergic action, meclizine hydrochloride  should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland.

The following adverse reactions associated with the use of meclizine hydrochloride  were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. On rare occasions blurred vision has been reported.

Common adverse reactions are anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. On rare occasions blurred vision has been reported ( 6).

To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.