MECLIZINE HYDROCHLORIDE 12.5 mg Tablet, 90-count
Other active recalls for Meclizine Hydrochloride (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Antiemetic class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Meclizine is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. It is most effective if taken before symptoms appear.
Read the full MedlinePlus article ↗- Meclizine is mainly used to prevent and treat the nausea, vomiting, and dizziness that comes with motion sickness — whether you're on a boat, in a car, or on a plane. It's also use...
- For the best chance of preventing motion sickness, take meclizine about one hour before you start traveling. After that first dose, you can take it once every 24 hours as needed fo...
- Yes, drowsiness is the most common side effect — it's actually worth planning around. Avoid driving or operating heavy machinery until you know how it affects you. And definitely s...
- This one requires a conversation with your doctor. Human studies haven't clearly linked meclizine to birth defects, but animal studies did show fetal harm at doses similar to what...
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII LMI26O6933
Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
-
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
-
UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
-
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.1825 | $16.43 / 90 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Meclizine 12.5 mg 00536-1297-01 | RUGBY | 100 tablets | $0.030 | — | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 24689-0138-01 | APNAR | 100 tablets | $0.030 | — | Availability likely | — |
| Meclizine HCl 12.5 mg 57237-0333-01 | Rising | 100 tablets | $0.030 | — | Availability likely | — |
| Meclizine HCl 12.5 mg 68001-0528-00 | BluePoint | 100 tablets | $0.030 | — | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 00904-7375-61 | Major | 100 tablets | $0.046 | AA | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 16571-0660-01 | Rising | 100 tablets | $0.046 | — | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 42806-0012-01 | Epic | 100 tablets | $0.046 | AA | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 50268-0522-15 | AvPAK | 50 tablets | $0.046 | AA | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 53746-0441-01 | Amneal | 100 tablets | $0.046 | AA | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 59651-0807-01 | Aurobindo | 100 tablets | $0.046 | AA | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 59746-0122-06 | Jubilant | 100 tablets | $0.046 | AA | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 60687-0775-01 | American | 100 tablets | $0.046 | AA | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 62135-0952-90 | Chartwell | 90 tablets | $0.046 | AA | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 70710-1161-00 | Zydus | 1000 tablets | $0.046 | AA | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 00615-8514-39 | NCS | 30 tablets | — | AA | FDA listed | — |
| Meclizine 12.5 mg 16103-0386-08 | Pharbest | 100 tablets | — | — | FDA listed | — |
| Meclizine HCL 12.5 mg 17714-0117-01 | Advance | 100 tablets | — | — | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 63629-2432-01 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 65162-0441-03 | Amneal | 30 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 67296-2250-03 | Redpharm | 30 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 68788-8633-01 | Preferred | 10 tablets | — | — | FDA listed | — |
| Meclizine HCL 12.5 mg 69618-0027-01 | Reliable | 100 tablets | — | — | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 70518-3768-00 | REMEDYREPACK | 30 tablets | — | — | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 70771-1539-00 | Zydus | 1000 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 71205-0416-10 | Proficient | 10 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 71205-0647-10 | Proficient | 10 tablets | — | — | FDA listed | — |
| Meclizine HCL 12.5 mg 71205-0762-30 | Proficient | 30 tablets | — | — | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 71335-0153-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mgthis 71335-1563-03 | Bryant | 90 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 71335-1872-01 | Bryant | 30 tablets | — | — | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 71335-3139-01 | Bryant | 1000 tablets | — | — | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 71335-3141-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 72162-1690-00 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 72189-0302-30 | DirectRx | 30 tablets | — | — | FDA listed | — |
| Meclizine 12.5 mg 73057-0386-08 | Ulai | 100 tablets | — | — | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 76420-0797-01 | Asclemed | 100 tablets | — | — | FDA listed | — |
| Meclizine 12.5 mg 80513-0427-02 | Advanced | 200 tablets | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71335-1563-01 | 30 TABLET in 1 BOTTLE (71335-1563-1) | 2010-06-04 | Active |
| 71335-1563-02 | 60 TABLET in 1 BOTTLE (71335-1563-2) | 2010-06-04 | Active |
| 71335-1563-03 You're viewing this | 90 TABLET in 1 BOTTLE (71335-1563-3) | 2010-06-04 | Active |
| 71335-1563-04 | 28 TABLET in 1 BOTTLE (71335-1563-4) | 2010-06-04 | Active |
| 71335-1563-05 | 20 TABLET in 1 BOTTLE (71335-1563-5) | 2010-06-04 | Active |
| 71335-1563-06 | 120 TABLET in 1 BOTTLE (71335-1563-6) | 2010-06-04 | Active |
| 71335-1563-07 | 100 TABLET in 1 BOTTLE (71335-1563-7) | 2010-06-04 | Active |
You're viewing one of 7 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 71335-1563-03?
What is the difference between NDC 71335-1563-03 and NDC 71335-1563-05?
What NDC number is used to bill for this package of MECLIZINE HYDROCHLORIDE 12.5 mg Tablet?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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 ( 1 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Recommended dosage: 25 mg to 100 mg daily, in divided doses ( 2.1 ). Tablets: Swallow whole ( 2.2 ).
2.1Recommended Dosage The recommended dosage is 25 mg to 100 mg daily administered orally, in divided doses, depending upon clinical response.
2.2Administration Instructions Tablets Meclizine hydrochloride tablets must be swallowed whole.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Meclizine hydrochloride tablets USP, 12.5 mg (Blue, oval shaped tablets, debossed with “TL 122” with score on one side and plain on the other side.) Meclizine hydrochloride tablets USP, 25 mg (Yellow, oval shaped tablets, debossed with “TL 121” with score on one side and plain on the other side.) Tablets: 12.5 mg, and 25 mg ( 3 ).
⛔ Contraindications ▾
4 CONTRAINDICATIONS 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 ( 4 ).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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 ).
5.1Drowsiness 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) ].
5.2Concurrent 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.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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 Jubilant Cadista Pharmaceuticals Inc. at 1-800313-4623 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS 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 ).
7.1CNS 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) ].
7.2CYP2D6 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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 to 4% and 15 to 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/m 2 ) basis.
8.2Lactation 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.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5Geriatric 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.
8.6Hepatic 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.
8.7Renal 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.
8.8Genetic 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.
🤰 Pregnancy ▾
8.1Pregnancy 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 to 4% and 15 to 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/m 2 ) basis.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The precise mechanism by which meclizine exerts its therapeutic effect is unknown but is presumed to involve antagonism of the histamine H1 receptor.
12.2Pharmacodynamics There are no relevant pharmacodynamic data regarding meclizine.
12.3Pharmacokinetics The available pharmacokinetic information for meclizine following oral administration has been summarized from published literature. Absorption Meclizine is absorbed after oral administration with maximum plasma concentrations reaching at a median T max value of 3 hours post-dose (range: 1.5 to 6 hours) for the tablet dosage form. Distribution Drug distribution characteristics for meclizine in humans are unknown.
Elimination Meclizine has a plasma elimination half-life of about 5-6 hours in humans. Metabolism In an in vitro metabolic study using human hepatic microsome and recombinant CYP enzyme, CYP2D6 was found to be the dominant enzyme for metabolism of meclizine.
🧬 Mechanism of Action ▾
12.1Mechanism of Action The precise mechanism by which meclizine exerts its therapeutic effect is unknown but is presumed to involve antagonism of the histamine H1 receptor.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Product: 71335-1563 NDC: 71335-1563-1 30 TABLET in a BOTTLE NDC: 71335-1563-2 60 TABLET in a BOTTLE NDC: 71335-1563-3 90 TABLET in a BOTTLE NDC: 71335-1563-4 28 TABLET in a BOTTLE NDC: 71335-1563-5 20 TABLET in a BOTTLE NDC: 71335-1563-6 120 TABLET in a BOTTLE NDC: 71335-1563-7 100 TABLET in a BOTTLE
📋 Description ▾
11 DESCRIPTION Meclizine hydrochloride, USP 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 Meclizine hydrochloride tablets, USP are available in two different strengths: 12.5 mg and 25 mg.
In addition, each tablet contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Also, meclizine hydrochloride tablets USP, 12.5 mg contains FD&C blue #1 aluminum lake (11-13%) and meclizine hydrochloride tablets USP, 25 mg contains D&C yellow #10 aluminum lake (15 to 20%). 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.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Administration Instructions Advise patients that the tablets must be swallowed whole [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) ].
Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA Rev. # 07/2019