Quick answers
- What is Meclizine hydrochloride used for?
- The FDA-approved label (Meclizine Hydrochloride, Rising Pharma Holdings, Inc., June 2, 2025) says: “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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Meclizine hydrochloride?
- The “Adverse Reactions” section of the FDA label (Meclizine Hydrochloride, Rising Pharma Holdings, Inc., June 2, 2025) begins: “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.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Meclizine hydrochloride?
- The “Drug Interactions” section of the FDA label (Meclizine Hydrochloride, Rising Pharma Holdings, Inc., June 2, 2025) begins: “Coadministration of meclizine hydrochloride with other CNS depressants, including alcohol, may result in increased CNS depression (7.1).” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Meclizine hydrochloride have a boxed warning?
- The label we quote has no boxed warning, but 1 of 59 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Meclizine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Meclizine hydrochloride been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started March 16, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Meclizine hydrochloride?
- 29 companies list prescription products of Meclizine hydrochloride in the FDA NDC Directory, including Bryant Ranch Prepack, Proficient Rx LP and NuCare Pharmaceuticals, Inc.
What Meclizine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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.
— FDA label: Meclizine Hydrochloride, Rising Pharma Holdings, Inc., effective June 2, 2025. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, oral), Meclizine Hydrochloride, Rising Pharma Holdings, Inc.; it covers 4 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 59 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
1 of 59 FDA labels for this medicine have a boxed warning.
Meclizine hydrochloride side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
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.
Read more of this section
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.
— FDA label: Meclizine Hydrochloride, Rising Pharma Holdings, Inc., effective June 2, 2025. Read the full label on DailyMed →
Meclizine hydrochloride drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
Coadministration of meclizine hydrochloride with other CNS depressants, including alcohol, may result in increased CNS depression (7.1).
Read more of this section
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.
— FDA label: Meclizine Hydrochloride, Rising Pharma Holdings, Inc., effective June 2, 2025. Read the full label on DailyMed →
Meclizine hydrochloride dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
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.
Read more of this section
Chewable Tablets Meclizine hydrochloride chewable tablets must be chewed or crushed completely before swallowing. Do not swallow chewable tablets whole.
— FDA label: Meclizine Hydrochloride, Rising Pharma Holdings, Inc., effective June 2, 2025. Read the full label on DailyMed →
Meclizine hydrochloride in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a 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.
Read more of this section
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.
— FDA label: Meclizine Hydrochloride, Rising Pharma Holdings, Inc., effective June 2, 2025. Read the full label on DailyMed →
When Meclizine hydrochloride should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
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.
— FDA label: Meclizine Hydrochloride, Rising Pharma Holdings, Inc., effective June 2, 2025. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet · Tablet, film coated · Tablet, chewable |
|---|---|
| Route | Oral |
| Prescription products | 80 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| meclizine hydrochloride 12.5 mg tablet | Generic | $0.0429 per tablet |
| meclizine hydrochloride 12.5 mg tablet, film coated | Generic | $0.0429 per tablet |
| meclizine hydrochloride 25 mg tablet | Generic | $0.0763 per tablet |
| meclizine hydrochloride 25 mg tablet, film coated | Generic | $0.0763 per tablet |
| meclizine hydrochloride 50 mg tablet | Generic | $2.47 per tablet |
| meclizine hydrochloride 50 mg tablet, film coated | Generic | $2.47 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack10 products
- Proficient Rx LP5 products
- NuCare Pharmaceuticals, Inc.5 products
- A-S Medication Solutions4 products
- Redpharm Drug4 products
- Rising Pharma Holdings, Inc.4 products
- Asclemed USA, Inc.4 products
- QPharma, Inc.3 products
- Chartwell RX, LLC3 products
- Amneal Pharmaceuticals LLC3 products
- Remedyrepack Inc.3 products
- Northwind Health Company, LLC3 products
- Aurobindo Pharma Limited3 products
- American Health Packaging2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Jubilant Cadista Pharmacuticals Inc.2 products
- St. Mary's Medical Park Pharmacy2 products
- Preferred Pharmaceuticals Inc.2 products
- Amneal Pharmaceuticals of New York LLC2 products
- NCS HealthCare of KY, LLC dba Vangard Labs2 products
- Major Pharmaceuticals2 products
- AvPAK2 products
- Epic Pharma, LLC2 products
- Zydus Lifesciences Limited2 products
- Coupler LLC1 product
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 product
- Direct_Rx1 product
- DirectRx1 product
- Advanced Rx of Tennessee, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA010721 ANTIVERT | Casper Pharma LLC | February 14, 1957 | 9, latest June 28, 2019 2019: Efficacy · 2018: Labeling · 2018: Efficacy |
Generic approvals (7)
- ANDA040659Jubilant Cadista · June 4, 2010
- ANDA201451Amneal Pharms · February 23, 2011
- ANDA200294Epic Pharma LLC · April 13, 2012
- ANDA202640Aurobindo Pharma USA · September 17, 2012
- ANDA205136Heritage · February 22, 2019
- ANDA213957Zydus Lifesciences · June 23, 2020
- ANDA203003Chartwell Rx · August 11, 2022
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 16, 2026 · Class II · Ongoing · D-0418-2026
Failed tablet specifications.
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217. — Amerisource Health Services LLC
-
April 13, 2022 · Class II · Terminated · D-1037-2022
cGMP deviations: Temperature abuse
Meclizine Hydrochloride Tablets, USP, 25 mg, 50-count cartons (5 x10 unit dose), 10 Tablets per card, 5 cards per carton, Rx only, MFG: Avkare Inc., NDC 50268-523-15 — Mckesson Medical-Surgical Inc. Corporate Office
-
March 8, 2022 · Class I · Terminated · D-0767-2022
Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801, NDC 59746-122-06 — Jubilant Cadista Pharmaceuticals, Inc.
-
October 30, 2017 · Class III · Terminated · D-0082-2018
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06 — Jubilant Cadista Pharmaceuticals, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 995624, 995632, 995666, 995686 |
|---|---|
| SPL set ID of the quoted label | c9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd |
| FDA labels (SPL) | 59 |
| FDA applications | NDA010721, 7 ANDA |
| Active ingredients (FDA) | MECLIZINE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- Meclizine sold over the counterDrug Facts label and store brands
- Bryant Ranch PrepackMaker or distributor
- Proficient Rx LPMaker or distributor
- NuCare Pharmaceuticals, Inc.Maker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Meclizine Hydrochloride, Rising Pharma Holdings, Inc., effective June 2, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →