FDA Label for Meclizine Hydrochloride
View Indications, Usage & Precautions
Meclizine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Avkare. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
Chemically, meclizine hydrochloride is 1-( p-chloro-α-phenylbenzyl)-4-( m-methylbenzyl) piperazine dihydrochloride monohydrate.
Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and talc. The 12.5 mg tablets also contain FD&C Blue # 1 Aluminum Lake. The 25 mg tablet also contains D&C Yellow # 10 Aluminum Lake.
Clinical Pharmacology
Meclizine Hydrochloride is an antihistamine which shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. It has a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum.
Indications And Usage
Management of nausea and vomiting, and dizziness associated with motion sickness.
Contraindications
Meclizine HCl is contraindicated in individuals who have shown a previous hypersensitivity to it.
Warnings
Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery.
Patients should avoid alcoholic beverages while taking this drug.
Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland.
Precautions
Pediatric Use
Clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age.
Pregnancy Use
Pregnancy Category B. Reproduction studies in rats have shown cleft palates at 25 to 50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that meclizine increases the risk of abnormalities when administered during pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, meclizine, or any other medication, should be used during pregnancy only if clearly necessary.
Adverse Reactions
Drowsiness, dry mouth and, on rare occasions, blurred vision have been reported.
Dosage And Administration
Motion Sickness
The initial dose of 25 to 50 mg of Meclizine Hydrochloride Tablets should be taken one hour prior to travel for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.
How Supplied
Meclizine Hydrochloride Tablets, USP 12.5 mg are light blue colored, oval shaped tablets with “AN 441” debossed on one side and plain on the other side.
They are available as follows:
Bottles of 90: NDC 42291-608-90
Bottles of 1000: NDC 42291-608-10
Meclizine Hydrochloride Tablets, USP 25 mg are light yellow colored, oval shaped tablets with “AN 442” debossed on one side and plain on the other side.
They are available as follows:
Bottles of 90: NDC 42291-609-90
Bottles of 1000: NDC 42291-609-10
Meclizine Hydrochloride Tablets, USP 50 mg are white, oval shaped, partially bisected tablets with “AN 444” debossed on one side and plain on the other side.
They are available as follows:
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container.
Package Label.Principal Display Panel
AvKARE
NDC 42291-608-10
Meclizine Hydrochloride Tablets, USP
12.5 mg
1000 Tablets Rx Only
Each tablets contains:
Meclizine HCl..................12.5mg
Store at 20 o to 25 oC (68 o to 77 oF) [See USP Controlled Room Temperature.]
Dispense in tight, light-resistant containers as defined in the USP.
DOSAGE AND USE: See accompanying prescribing information.
MOTION SICKNESS: 25mg to 50mg daily.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 02/11 AV Rev. 04/13 (P)
N3 42291 60810 8
AvKARE
NDC 42291-609-10
Meclizine Hydrochloride Tablets, USP
25 mg
1000 Tablets Rx Only
Each tablets contains:
Meclizine HCl..................25mg
Store at 20 o to 25 oC (68 o to 77 oF) [See USP Controlled Room Temperature.]
Dispense in tight, light-resistant containers as defined in the USP.
DOSAGE AND USE: See accompanying prescribing information.
MOTION SICKNESS: 25mg to 50mg daily.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 02/11 AV Rev. 04/13 (P)
N3 42291 60910 5
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