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Medicine guide

Meclizine Hydrochloride

25 mg · Tablet

  • Prescription only
  • Antiemetic
Active substance
Meclizine Hydrochloride
Made by
St. Mary's Medical Park Pharmacy

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-06-21

What it is

Antiemetic

Used for
  • Meclizine hydrochloride is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in
The label’s usual adult dose

Recommended dosage: 25 mg to 100 mg daily, in divided doses ( 2.1 ).

Full directions ↓
Do not take it if

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

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
65other products contain Meclizine Hydrochloride — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

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

From the official label · 2026-06-21 · DailyMed

How it works

From this product’s own US prescribing label.

The precise mechanism by which meclizine exerts its therapeutic effect is unknown but is presumed to involve antagonism of the histamine H1 receptor.

Peak level after3 h
Half-life5–6 h
Mostly cleared after≈ 27.5 hfive half-lives — our arithmetic
PeakHalf gone27.5 h0
The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-06-21

Do not take it if

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

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • Recommended dosage: 25 mg to 100 mg daily, in divided doses ( 2.1 ).
  • Tablets: Swallow whole ( 2.2 ).
  • Chewable Tablets:
  • Must be chewed or crushed before swallowing; do not 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 Tablets Meclizine hydrochloride tablets must be swallowed whole.
  • Chewable Tablets Meclizine hydrochloride chewable tablets must be chewed or crushed completely before swallowing.
  • Do not swallow chewable tablets whole.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • 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.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Risk Summary Data from epidemiological studies have not generally indicated a drug-associated risk of major birth defects with meclizine during pregnancy.
  • However, in a published study, an increased incidence of fetal malformations was observed following oral administration of meclizine to pregnant rats during the period of organogenesis, at doses similar to those used clinically.
  • In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
  • The background risk of major birth defects and miscarriage for the indicated population is unknown.
  • Data Human Data Epidemiological studies reporting on pregnancies exposed to meclizine have not identified an association between the use of meclizine during pregnancy and an increased risk of major birth defects.
  • Animal Data In a published study, oral administration of meclizine (25-250 mg/kg) to pregnant rats during the period of organogenesis resulted in a high incidence of fetal malformations.
  • These effects occurred at doses as low as 25 mg/kg, which is approximately 2 times the maximum recommended human dose (100 mg) on a body surface area (mg/m2) basis.
  • IN SPECIFIC POPULATIONS
  • 8.1 Pregnancy Risk Summary Data from epidemiological studies have not generally indicated a drug-associated risk of major birth defects with meclizine during pregnancy.
  • However, in a published study, an increased incidence of fetal malformations was observed following oral administration of meclizine to pregnant rats during the period of organogenesis, at doses similar to those used clinically.
  • In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
  • The background risk of major birth defects and miscarriage for the indicated population is unknown.
  • Data Human Data Epidemiological studies reporting on pregnancies exposed to meclizine have not identified an association between the use of meclizine during pregnancy and an increased risk of major birth defects.
  • Animal Data In a published study, oral administration of meclizine (25-250 mg/kg) to pregnant rats during the period of organogenesis resulted in a high incidence of fetal malformations.
  • These effects occurred at doses as low as 25 mg/kg, which is approximately 2 times the maximum recommended human dose (100 mg) on a body surface area (mg/m2) basis.
  • 8.2 Lactation Risk Summary There are no data on the presence of meclizine in human milk, the effects on the breastfed infant, or the effects on milk production.
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for meclizine hydrochloride and any potential adverse effects on the breastfed infant from meclizine hydrochloride or from the underlying maternal condition.
  • 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.
  • 8.5 Geriatric Use In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
  • 8.6 Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of meclizine has not been evaluated.
  • As meclizine hydrochloride undergoes metabolism, hepatic impairment may result in increased systemic exposure of meclizine.
  • Treatment with meclizine hydrochloride should be administered with caution in patients with hepatic impairment.
  • 8.7 Renal Impairment The effect of renal impairment on the pharmacokinetics of meclizine has not been evaluated.
  • Because of a potential for drug/metabolite accumulation, meclizine hydrochloride should be administered with caution in patients with renal impairment and in the elderly, as renal function generally declines with age.
  • 8.8 Genetic CYP2D6 Polymorphism The genetic polymorphism of CYP2D6 that results in poor-, intermediate-, extensive-, and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure.
  • Therefore, when meclizine hydrochloride is administered to patients with CYP2D6 polymorphism, monitor for adverse reactions and clinical effect accordingly.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • 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.

Quoted from the official label, section “Drug Interactions”.

Use in children

Safety and effectiveness in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Quoted from the official label, section “Geriatric Use”.

Side effects

  • 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 Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • Administration Instructions Advise patients that the tablets must be swallowed whole, but chewable tablets must be chewed or crushed completely before swallowing [see Dosage and Administration (2.1) ] .
  • Adverse Reactions Advise patients that meclizine hydrochloride may cause anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision [see Warnings and Precautions (5.1) , Adverse Reactions (6) ] .
  • Inform patients that meclizine hydrochloride may impair their ability to engage in potentially dangerous activities, such as operating machinery or vehicles.
  • Concomitant Drug Interactions Advise patients regarding medications that should not be taken in combination with meclizine hydrochloride or that may necessitate increased monitoring [see Drug Interactions (7.1, 7.2) ] .
  • Inform patients that alcohol may increase adverse reactions.
  • Concurrent Medical Conditions Advise patients to notify their healthcare provider about all of their medical conditions, including if they are pregnant or plan to become pregnant or if they are breastfeeding [see Warnings and Precautions (5.2) , Use in Specific Populations (8.1, 8.2) ] .
  • Distributed by: Rising Pharma Holdings, Inc.
  • East Brunswick, NJ 08816 PIA66201-01 Revised: 05/2025

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

  • FORMS AND STRENGTHS Tablets 12.5 mg:
  • oval-shaped, biconvex, two-layered tablet, one blue to pale blue layer debossed with “34” and one white to off white layer debossed with “L”. 25 mg:
  • oval-shaped, biconvex, two-layered tablet, one yellow to pale yellow layer debossed with “49” and one white to off white layer debossed with “L”. 50 mg:
  • oval-shaped, biconvex, two-layered tablet, one blue to pale blue layer debossed with “50” and one yellow to pale yellow layer and debossed with “L”.
  • Chewable Tablets 25 mg:
  • pink colored round tablets debossed with “M 25” on one side and break line on other side.
  • Tablets: 12.5 mg, 25 mg, and 50 mg ( 3 ).
  • Chewable Tablets: 25 mg ( 3 ).

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • 16.1 How Supplied Tablets Meclizine hydrochloride 25 mg tablets are oval shaped, biconvex, two-layered tablet, one yellow to pale yellow layer debossed with “49” and one white to off white layer debossed with “L”.
  • Bottles of 30 NDC 60760-661-30 Bottles of 90 NDC 60760-661-90
  • Storage and Handling
  • Store at 20 o C to 25 o C (68 o F to 77 o F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container (USP).

Quoted from the official label, section “How Supplied”.

What is in it

  • Meclizine hydrochloride, a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder.
  • It has the following structural formula:
  • Chemically, meclizine hydrochloride is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.
  • Tablets Inactive ingredients for the tablets are:
  • corn starch; dibasic calcium phosphate; magnesium stearate; polyethylene glycol; sucrose.
  • The 12.5 mg tablets also contain: FD&C Blue # 1.
  • The 25 mg tablets also contain: FD&C Yellow # 6 and D&C Yellow # 10.
  • The 50 mg tablets also contain: FD&C Blue # 1, FD&C Yellow # 6 and D&C Yellow # 10.
  • 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.
  • Each meclizine hydrochloride 50 mg tablet contains 50 mg of meclizine dihydrochloride equivalent to 42.14 mg of meclizine free base.
  • Chewable Tablets Inactive ingredients for the chewable tablets are:
  • corn starch, colloidal silicon dioxide, FD&C Red # 40, lactose monohydrate, magnesium stearate, raspberry flavor, saccharin sodium, and talc.
  • Each meclizine hydrochloride 25 mg chewable tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base. struct-1.jpg

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • SugarssucroseRelevant to diabetes and dental health.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (94)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

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Details

Made bySt. Mary's Medical Park Pharmacy
Active substanceMeclizine Hydrochloride
Used inDigestion, stomach, diabetes and nutrition
Strength25 mg
FormTablet
RouteOral
Packs30 TABLET in 1 BOTTLE, PLASTIC · 90 TABLET in 1 BOTTLE, PLASTIC
NDC60760-661

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

65 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

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See every product with Meclizine Hydrochloride