The following Structured Product Label (SPL) was submitted to the FDA by Avpak for the product Meclizine Hydrochloride (NDC 50268-522). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, clinical pharmacology, indications and usage, contraindications, warnings, precautions, adverse reactions, dosage and administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
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.
Management of nausea and vomiting, and dizziness associated with motion sickness.
Meclizine HCl is contraindicated in individuals who have shown a previous hypersensitivity to it.
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.
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.
Drowsiness, dry mouth and, on rare occasions, blurred vision have been reported.
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.
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:
10 Tablets per card, 5 cards per carton NDC 50268-522-15
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:
10 Tablets per card, 5 cards per carton NDC 50268-523-15
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.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a blister punch material for Institutional Use Only.
Keep out of reach of children
NDC 50268-522-15
Meclizine Hydrochloride Tablets, USP
12.5 mg
Rx Only
50 Tablets (5 X 10) Unit Dose
5026852215
NDC 50268-522-15
Meclizine Hydrochloride Tablets, USP
12.5 mg
Rx Only
50 Tablets (5 X 10) Unit Dose
5026852215
Each tablet contains:
Meclizine HCl..................12.5 mg
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: 25 mg to 50 mg daily.
PLEASE KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
AvPAK
A PRODUCT OF AvKARE
Mfg. Rev. 02-2011 AV 07/13 (P)
NDC 50268-523-15
Meclizine Hydrochloride Tablets, USP
25 mg
Rx Only
50 Tablets (5 X 10) Unit Dose
5026852315
NDC 50268-523-15
Meclizine Hydrochloride Tablets, USP
25 mg
Rx Only
50 Tablets (5 X 10) Unit Dose
5026852315
Each tablet contains:
Meclizine HCl..................25 mg
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: 25 mg to 50 mg daily.
PLEASE KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
AvPAK
A PRODUCT OF AvKARE
Mfg. Rev. 02-2011 AV 07/13 (P)
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