Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Meclizine Hydrochloride Tablets USP, 12.5 mg are light blue to blue colored, spotted, oval shaped, biconvex uncoated tablet, debossed with '1161' on one side and plain on the other side and are supplied as follows: NDC 70710-1161-3 in bottles of 30 tablets with child-resistance closure NDC 70710-1161-9 in bottles of 90 tablets with child-resistance closure NDC 70710-1161-1 in bottles of 100 tablets with child-resistance closure NDC 70710-1161-0 in bottles of 1000 tablets with non-child-resistance closure NDC 70710-1161-4 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose) Meclizine Hydrochloride Tablets USP, 25 mg are light yellow to yellow colored, spotted, oval shaped, biconvex uncoated tablets debossed with '1162' on one side and plain on the other side and are supplied as follows: NDC 70710-1162-3 in bottles of 30 tablets with child-resistance closure NDC 70710-1162-9 in bottles of 90 tablets with child-resistance closure NDC 70710-1162-1 in bottles of 100 tablets with child-resistance closure NDC 70710-1162-0 in bottles of 1000 tablets with non-child-resistance closure NDC 70710-1162-4 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose) 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).; 16.1 How Supplied Meclizine Hydrochloride Tablets USP, 12.5 mg are light blue to blue colored, spotted, oval shaped, biconvex uncoated tablet, debossed with '1161' on one side and plain on the other side and are supplied as follows: NDC 70710-1161-3 in bottles of 30 tablets with child-resistance closure NDC 70710-1161-9 in bottles of 90 tablets with child-resistance closure NDC 70710-1161-1 in bottles of 100 tablets with child-resistance closure NDC 70710-1161-0 in bottles of 1000 tablets with non-child-resistance closure NDC 70710-1161-4 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose) Meclizine Hydrochloride Tablets USP, 25 mg are light yellow to yellow colored, spotted, oval shaped, biconvex uncoated tablets debossed with '1162' on one side and plain on the other side and are supplied as follows: NDC 70710-1162-3 in bottles of 30 tablets with child-resistance closure NDC 70710-1162-9 in bottles of 90 tablets with child-resistance closure NDC 70710-1162-1 in bottles of 100 tablets with child-resistance closure NDC 70710-1162-0 in bottles of 1000 tablets with non-child-resistance closure NDC 70710-1162-4 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose); PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70710-1161-1 Meclizine Hydrochloride Tablets, USP 12.5 mg 100 Tablets Rx Only Zydus NDC 70710-1162-1 Meclizine Hydrochloride Tablets, USP 25 mg 100 Tablets Rx Only Zydus label label
- 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Meclizine Hydrochloride Tablets USP, 12.5 mg are light blue to blue colored, spotted, oval shaped, biconvex uncoated tablet, debossed with '1161' on one side and plain on the other side and are supplied as follows: NDC 70710-1161-3 in bottles of 30 tablets with child-resistance closure NDC 70710-1161-9 in bottles of 90 tablets with child-resistance closure NDC 70710-1161-1 in bottles of 100 tablets with child-resistance closure NDC 70710-1161-0 in bottles of 1000 tablets with non-child-resistance closure NDC 70710-1161-4 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose) Meclizine Hydrochloride Tablets USP, 25 mg are light yellow to yellow colored, spotted, oval shaped, biconvex uncoated tablets debossed with '1162' on one side and plain on the other side and are supplied as follows: NDC 70710-1162-3 in bottles of 30 tablets with child-resistance closure NDC 70710-1162-9 in bottles of 90 tablets with child-resistance closure NDC 70710-1162-1 in bottles of 100 tablets with child-resistance closure NDC 70710-1162-0 in bottles of 1000 tablets with non-child-resistance closure NDC 70710-1162-4 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose) 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).
- 16.1 How Supplied Meclizine Hydrochloride Tablets USP, 12.5 mg are light blue to blue colored, spotted, oval shaped, biconvex uncoated tablet, debossed with '1161' on one side and plain on the other side and are supplied as follows: NDC 70710-1161-3 in bottles of 30 tablets with child-resistance closure NDC 70710-1161-9 in bottles of 90 tablets with child-resistance closure NDC 70710-1161-1 in bottles of 100 tablets with child-resistance closure NDC 70710-1161-0 in bottles of 1000 tablets with non-child-resistance closure NDC 70710-1161-4 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose) Meclizine Hydrochloride Tablets USP, 25 mg are light yellow to yellow colored, spotted, oval shaped, biconvex uncoated tablets debossed with '1162' on one side and plain on the other side and are supplied as follows: NDC 70710-1162-3 in bottles of 30 tablets with child-resistance closure NDC 70710-1162-9 in bottles of 90 tablets with child-resistance closure NDC 70710-1162-1 in bottles of 100 tablets with child-resistance closure NDC 70710-1162-0 in bottles of 1000 tablets with non-child-resistance closure NDC 70710-1162-4 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose)
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70710-1161-1 Meclizine Hydrochloride Tablets, USP 12.5 mg 100 Tablets Rx Only Zydus NDC 70710-1162-1 Meclizine Hydrochloride Tablets, USP 25 mg 100 Tablets Rx Only Zydus label label
Overview
Meclizine hydrochloride, a histamine (H1) receptor antagonist, is a white to slightly yellowish, crystalline powder. It has the following structural formula: Chemically, meclizine hydrochloride, USP is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Inactive ingredients for the tablets are: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide and sodium starch glycolate. In addition, the 12.5 mg tablet contains FD&C Blue # 1 Aluminum Lake; and the 25 mg tablet contains D&C Yellow # 10 Aluminum Lake and FD&C Yellow # 6 Aluminum Lake. Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base. Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base. Image
Indications & Usage
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 ).
Dosage & Administration
Recommended dosage: 25 mg to 100 mg daily, in divided doses ( 2.1 ). Tablets: Swallow whole ( 2.2 ). 2.1 Recommended Dosage The recommended dosage is 25 mg to 100 mg daily administered orally, in divided doses, depending upon clinical response. 2.2 Administration Instructions Meclizine hydrochloride tablets must be swallowed whole.
Warnings & Precautions
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 ). 5.1 Drowsiness 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 )]. 5.2 Concurrent Medical Conditions Because of its potential anticholinergic action, meclizine hydrochloride should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland.
Contraindications
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 ).
Adverse Reactions
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 .
Drug Interactions
Coadministration of meclizine hydrochloride with other CNS depressants, including alcohol, may result in increased CNS depression ( 7.1 ). CYP2D6 inhibitors: As meclizine is metabolized by CYP2D6, there is a potential for drug-drug interactions between meclizine hydrochloride and CYP2D6 inhibitors ( 7.2 ). 7.1 CNS Depressants There may be increased CNS depression when meclizine hydrochloride is administered concurrently with other CNS depressants, including alcohol [see Warnings and Precautions ( 5.1 )] . 7.2 CYP2D6 Inhibitors Based on in-vitro evaluation, meclizine is metabolized by CYP2D6. Therefore, there is a possibility for a drug interaction between meclizine hydrochloride and CYP2D6 inhibitors. Therefore, monitor for adverse reactions and clinical effect accordingly.
Storage & Handling
16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).
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