Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Meclizine Hydrochloride Tablets USP are available as: 25 mg, white, modified oval-shaped tablets, de-bossed “ Є14 ” on one side and plain on the other side. They are supplied as follows: NDC 63187-258-10 in bottles of 10 NDC 63187-258-20 in bottles of 20 NDC 63187-258-30 in bottles of 30 NDC 63187-258-60 in bottles of 60 NDC 63187-258-90 in bottles of 90 Store at 20º to 25ºC (68 to 77ºF) [See USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Made in USA Revised April 2014 MF012REV04/14 OE1035 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320; PRINCIPAL DISPLAY PANEL 63187-258-10
- HOW SUPPLIED Meclizine Hydrochloride Tablets USP are available as: 25 mg, white, modified oval-shaped tablets, de-bossed “ Є14 ” on one side and plain on the other side. They are supplied as follows: NDC 63187-258-10 in bottles of 10 NDC 63187-258-20 in bottles of 20 NDC 63187-258-30 in bottles of 30 NDC 63187-258-60 in bottles of 60 NDC 63187-258-90 in bottles of 90 Store at 20º to 25ºC (68 to 77ºF) [See USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Made in USA Revised April 2014 MF012REV04/14 OE1035 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320
- PRINCIPAL DISPLAY PANEL 63187-258-10
Overview
Chemically, meclizine hydrochloride is 1-( p -chloro-α-phenylbenzyl)-4-( m -methylbenzyl) piperazine dihydrochloride monohydrate. C 25 H 27 CIN 2 ·2HCl·H 2 0 M.W. 481.89 Meclizine hydrochloride tablets, USP are available in two different strengths, 12.5 mg and 25 mg. Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium and magnesium stearate. The 12.5 mg tablet also contains FD&C Blue #1 Aluminum Lake. Chemical Structure
Dosage & Administration
Motion Sickness The initial dose of 25 to 50 mg of meclizine hydrochloride should be taken one hour prior to embarkation for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey. Motion Sickness The initial dose of 25 to 50 mg of meclizine hydrochloride should be taken one hour prior to embarkation for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.
Warnings & Precautions
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. Usage in Children Clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age. Usage in Pregnancy Pregnancy Category B Reproduction studies in rats have shown cleft palates at 25-50 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. Usage in Children Clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age. Usage in Pregnancy Pregnancy Category B Reproduction studies in rats have shown cleft palates at 25-50 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. Pregnancy Category B Reproduction studies in rats have shown cleft palates at 25-50 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.
Boxed Warning
Based on a review of this drug by the National Academy of Sciences - National Research Council and/or other information, FDA has classified the indications as follows: Effective: Management of nausea and vomiting, and dizziness associated with motion sickness. Final classification of the less than effective indications requires further investigation.
Contraindications
Meclizine hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.
Adverse Reactions
Anaphylactoid reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision have been reported.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.