Meclizine 25

Manufacturer
The Generic Pharmaceutical Company
Effective date
2017-01-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:25

Label at a glance#

ProductMeclizine 25
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

For prevention and treatment of these symptoms associated with motion sickness: nausea vomiting dizziness

Dosage and administration

Do not exceed recommended dosage. To prevent motion sickness; take the first dose one hour before starting activity. Adults and children 12 years of age and over: 1 to 2 tablets once daily, or as directed by a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients (in each immediate-release tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine 25 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Indications and Usage

INDICATIONS & USAGE SECTION

  • For prevention and treatment of these symptoms associated with motion sickness:
    • nausea
    • vomiting
    • dizziness

Warnings

WARNINGS SECTION

  • Do not use for children under 12 years of age unless directed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,

  • ask health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of accidental overdose, seek medical help or contact a Poison Control Center immediately. 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended dosage.

To prevent motion sickness; take the first dose one hour before starting activity.

Adults and children 12 years of age and over:1 to 2 tablets once daily, or as directed by a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Questions and comments?

OTC - QUESTIONS SECTION

Call 1-205-313-8298

SPL UNCLASSIFIED SECTION

Manufactured for
The Generic Pharmaceutical Company, Inc.
Leeds, AL 35094

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57963-101-01
100 Tablets

Meclizine 25
Antiemetic

Each immediate-release tablet contains:
Meclizine HCl
25 mg

Store at 59°-86°F (15°-30°C)
[see USP Controlled Room Temperature].
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Manufactured for
The Generic Pharmaceutical Company, Inc.
Leeds, AL 35094

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label
PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995666meclizine HCl 25 MG Oral TabletPSN1
995666meclizine hydrochloride 25 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MECLIZINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57963-101-012022-01-28C16284748780-1d6a99b39-4e21-a426-e053-dadaa90af4c2Meclizine 25

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57963-101-01Meclizine 25100 in 1 BOTTLE, PLASTICTABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57963-101MECLIZINE 25 (MECLIZINE HYDROCHLORIDE) TABLET [THE GENERIC PHARMACEUTICAL COMPANY]1Legacy NDC, 1 package rows20170111_b13cb390-20ed-43ce-aa74-5a754539f6e2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57963-101-01EA - Each57963-101b2addbf7-78a0-406a-82de-d32ccf89f5fc12017-03-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57963-10157963-101-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6eafa4df-b743-4c70-9fe1-97c30b07d82db13cb390-20ed-43ce-aa74-5a754539f6e22017-01-09WarningsExact identifier
spl id: 6eafa4df-b743-4c70-9fe1-97c30b07d82d
spl set id: b13cb390-20ed-43ce-aa74-5a754539f6e2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.