MECLIZINE 12.5 mg/1
Meclizine HCl 12.5 mg · TABLET · RUGBY LABORATORIES
Meclizine is an over-the-counter medication taken by mouth that helps prevent and treat nausea, vomiting, and dizziness caused by motion sickness or vertigo. Each tablet contains 12.5 mg of meclizine hydrochloride.
Key Facts
- Brand Name
- MECLIZINE
- Generic Name
- Meclizine HCl 12.5 mg
- NDC Code (Product)
0536-1297- Manufacturer
- RUGBY LABORATORIES
- Strength
- 12.5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- M009
- Marketing Start
- 05/21/2020
Recall History
Sato Pharmaceutical Inc.
Subpotent Drug
Wilshire Pharmaceuticals Inc
Failed Dissolution Specifications
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
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness. For other uses consult your doctor
Dosage & Administration
Directions take dose one hour before travel starts tablets can be chewed or swallowed whole with water adults & children 12 years and over: take 1-2 tablets once daily children under 12 years: ask a doctor
Warnings
Warnings Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an elarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product you may get drowsy avoid alcoholic drinks alcohol, sedatives and tranquilizers may increse drowsiness be careful when driving a moor vehicle or operating machinery
Frequently Asked Questions
What is MECLIZINE used for?
Meclizine is an over-the-counter medication taken by mouth that helps prevent and treat nausea, vomiting, and dizziness caused by motion sickness or vertigo. Each tablet contains 12.5 mg of meclizine hydrochloride.
Is MECLIZINE a controlled substance?
MECLIZINE is not classified as a controlled substance by the DEA.
What is the generic name for MECLIZINE?
The generic name for MECLIZINE is Meclizine HCl 12.5 mg. There are 3 other brand versions of Meclizine HCl 12.5 mg.
What is the NDC code for MECLIZINE 12.5 mg/1?
The NDC (National Drug Code) for MECLIZINE 12.5 mg/1 is 0536-1297, listed by RUGBY LABORATORIES.