Drugplain

Meclizine HCl 12.5 mg/1

MECLIZINE HYDROCHLORIDE · TABLET · BluePoint Laboratories

3 Recalls on Record
Plain English

Meclizine HCl is a tablet containing meclizine hydrochloride at 12.5 mg/1, taken oral. Manufactured by BluePoint Laboratories.

Key Facts

Brand Name
Meclizine HCl
Generic Name
MECLIZINE HYDROCHLORIDE
NDC Code (Product)
68001-528
Manufacturer
BluePoint Laboratories
Strength
12.5 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M009
Marketing Start
03/14/2022

Recall History

3 Recalls on Record
Class II02/04/2021

Wilshire Pharmaceuticals Inc

Failed Dissolution Specifications

TerminatedVoluntary: Firm initiated
Class II09/02/2021

RISING PHARMACEUTICALS

Labeling: Incorrect Instructions

OngoingVoluntary: Firm initiated
Class II02/04/2021

Wilshire Pharmaceuticals Inc

Failed Dissolution Specifications

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue499 reports
dizziness457 reports
nausea410 reports
headache353 reports
fall341 reports
drug ineffective327 reports
diarrhoea325 reports
pain319 reports
product dose omission issue251 reports
dyspnoea237 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 HCl used for?

Meclizine HCl contains MECLIZINE HYDROCHLORIDE. It is a tablet taken oral. Consult your doctor for specific uses.

Is Meclizine HCl a controlled substance?

Meclizine HCl is not classified as a controlled substance by the DEA.

What is the generic name for Meclizine HCl?

The generic name for Meclizine HCl is MECLIZINE HYDROCHLORIDE. There are 11 other brand versions of MECLIZINE HYDROCHLORIDE.

What is the NDC code for Meclizine HCl 12.5 mg/1?

The NDC (National Drug Code) for Meclizine HCl 12.5 mg/1 is 68001-528, listed by BluePoint Laboratories.

Product NDC

68001-528

Package NDC

68001-528-00

Other Meclizine HCl Dosages

Other Meclizine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)