Drugplain

MECLIZINE 25 mg/1

Meclizine HCl 25mg · TABLET, CHEWABLE · PD-Rx Pharmaceuticals, Inc.

10 Recalls on Record
Plain English

Meclizine is an antihistamine used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness or vertigo. This chewable tablet is available over-the-counter in 25 mg doses.

Key Facts

Brand Name
MECLIZINE
Generic Name
Meclizine HCl 25mg
NDC Code (Product)
43063-804
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Strength
25 mg/1
Dosage Form
TABLET, CHEWABLE
Route
ORAL
Marketing Status
Application #
M009
Marketing Start
02/01/2018

Recall History

10 Recalls on Record
Class III10/01/2019

Sato Pharmaceutical Inc.

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class II02/04/2021

Wilshire Pharmaceuticals Inc

Failed Dissolution Specifications

TerminatedVoluntary: Firm initiated
Class III10/26/2015

Par Pharmaceutical Inc.

Failed Impurities/Degradation Specifications: Out of specification for impurities.

TerminatedVoluntary: Firm initiated
Class I03/08/2022

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

TerminatedVoluntary: Firm initiated
Class III11/25/2015

Golden State Medical Supply Inc.

Failed Impurities/Degradation Specifications: Out of specification for impurities.

TerminatedVoluntary: Firm initiated
Class III10/01/2019

Sato Pharmaceutical Inc.

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class III11/25/2015

Golden State Medical Supply Inc.

Failed Impurities/Degradation Specifications: Out of specification for impurities.

TerminatedVoluntary: Firm initiated
Class III10/01/2019

Sato Pharmaceutical Inc.

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class III10/26/2015

Par Pharmaceutical Inc.

Failed Impurities/Degradation Specifications: Out of specification for impurities.

TerminatedVoluntary: Firm initiated
Class III10/01/2019

Sato Pharmaceutical Inc.

Subpotent Drug

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

dizziness1,784 reports
nausea1,531 reports
fatigue1,515 reports
headache1,153 reports
diarrhoea1,143 reports
fall1,140 reports
pain1,102 reports
dyspnoea935 reports
asthenia913 reports
drug ineffective911 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 used for?

Meclizine is an antihistamine used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness or vertigo. This chewable tablet is available over-the-counter in 25 mg doses.

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 25mg. There are 3 other brand versions of Meclizine HCl 25mg.

What is the NDC code for MECLIZINE 25 mg/1?

The NDC (National Drug Code) for MECLIZINE 25 mg/1 is 43063-804, listed by PD-Rx Pharmaceuticals, Inc..

Product NDC

43063-804

Package NDC

43063-804-01

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

Data from openFDA · Public domain (CC0 1.0)