Meclizine Hydrochloride 25 mg/1
Meclizine Hydrochloride · TABLET · American Health Packaging
Meclizine Hydrochloride is a tablet containing meclizine hydrochloride at 25 mg/1, taken oral. Manufactured by American Health Packaging.
Key Facts
- Brand Name
- Meclizine Hydrochloride
- Generic Name
- Meclizine Hydrochloride
- NDC Code (Product)
60687-730- Manufacturer
- American Health Packaging
- Strength
- 25 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA201451
- Marketing Start
- 04/20/2023
Recall History
Sato Pharmaceutical Inc.
Subpotent Drug
Par Pharmaceutical Inc.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Jubilant Cadista Pharmaceuticals, Inc.
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
Golden State Medical Supply Inc.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Sato Pharmaceutical Inc.
Subpotent Drug
Golden State Medical Supply Inc.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Sato Pharmaceutical Inc.
Subpotent Drug
Par Pharmaceutical Inc.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Sato Pharmaceutical Inc.
Subpotent Drug
Amerisource Health Services LLC
Failed tablet specifications.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended dosage: 25 mg to 100 mg daily, in divided doses ( 2.1 ). Tablets: 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.
Contraindications
4 CONTRAINDICATIONS Meclizine hydrochloride tablets are contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see Adverse Reactions (6) and Description (11) ]. Meclizine hydrochloride tablets are contraindicated in patients with hypersensitivity to meclizine or any of the inactive ingredients ( 4 ).
Drug Interactions
7 DRUG INTERACTIONS Coadministration of meclizine hydrochloride tablets 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 tablets and CYP2D6 inhibitors ( 7.2 ). 7.1 CNS Depressants There may be increased CNS depression when meclizine hydrochloride tablets are 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 tablets and CYP2D6 inhibitors. Therefore, monitor for adverse reactions and clinical effect accordingly.
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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Meclizine Hydrochloride used for?
Meclizine Hydrochloride contains Meclizine Hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.
Is Meclizine Hydrochloride a controlled substance?
Meclizine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Meclizine Hydrochloride?
The generic name for Meclizine Hydrochloride is Meclizine Hydrochloride. There are 4 other brand versions of Meclizine Hydrochloride.
What is the NDC code for Meclizine Hydrochloride 25 mg/1?
The NDC (National Drug Code) for Meclizine Hydrochloride 25 mg/1 is 60687-730, listed by American Health Packaging.
Other Meclizine Hydrochloride Dosages
- Meclizine Hydrochloride12.5 mg/124689-138
- Meclizine Hydrochloride25 mg/142708-189
- Meclizine Hydrochloride25 mg/150090-5727
- Meclizine Hydrochloride12.5 mg/153746-441
- Meclizine Hydrochloride25 mg/160760-661
- Meclizine Hydrochloride25 mg/168071-2574
- Meclizine Hydrochloride12.5 mg/170518-3768
- Meclizine Hydrochloride25 mg/180425-0494
Other Meclizine Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)