meclinzine hydorchloride

Manufacturer
Bellegrove Medical Supply, Inc. | Future Pak, Ltd.
Effective date
2020-11-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:32:45

Label at a glance#

Productmeclinzine hydorchloride
Active ingredientMeclizine hydrochloride
Label structure8 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

Do not use
• for children under 12 years of age unless unless directed by a physician
• for frequent or prolonged use except under the advice of a physician

Ask a doctor before use if you have

breathing problems such as emphysema, asthma or pulmonary disease
glaucoma

if you are 

  • taking sedatives or tranquilizers

When using this product

drowsiness may occur
alcohol, sedatives and tranquilizers may increase the drowsiness effect
consult with your physician
avoid alcoholic beverages while taking this product
use caution when driving a motor vehicle or operating machinery

Do not exceed recommended dosage

If preganant or breast-feeding, ask a health professional before use

Keep out of reach of children.  In case of overdose, get medical help or contact Poison Control Center right away

Other information

  • store at room temperature 59-86 degrees F (15-30 degreesC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

DOSAGE AND ADMINISTAATION

DOSAGE & ADMINISTRATION SECTION

Directions

do not use more than directed
to provent motion sickness, take the first dose one hour before starting activity
Adults and children (12 years and older)

1 to 2 tablets once daily or as directed by a Physician

Do not exceed 2 tablets in 24 hours

Children under 12 years of age: Do not give to children under 12 years of age

INDICATION AND USAGE

INDICATIONS & USAGE SECTION

For the prevention and treatment of the nausea,vomating,or dizziness associated with motion sickness.

OTC-KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Do not use
• for children under 12 years of age unless unless directed by a physician
Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away

PURPOSE

OTC - PURPOSE SECTION

When using this product

drowsiness may occur
alcohol, sedatives and tranquilizers may increase the drowsiness effect
consult with your physician
avoid alcoholic beverages while taking this product
use caution when driving a motor vehicle or operating machinery

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

anhydrous lactose

Inactive ingredients

INACTIVE INGREDIENT SECTION

Anhydrous Lactose, Colloidal Silicon Dioxide, Crospovidone, Dextrose, FD&C red #40 aluminum lake, magnesium stearate, Microcrystalline Cellulose, Modified Corn Starch, Propylene Glycol, Raspberry Flavor, Silicon Dioxide, Sodium Saccharin, Stearic Acid, Talc and Vanilla Flavor.

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package labelPackage label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995632meclizine HCl 25 MG Chewable TabletPSN5
995632meclizine hydrochloride 25 MG Chewable TabletSCD5

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
59961-125-012022-01-28C16284748780-1d6a99b39-b279-a426-e053-dadaa90af4c2Meclizine Hydrochloride - Chewable

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59961-125-01meclinzine hydorchloride2 in 1 PACKAGETABLET, CHEWABLE25
59961-125-02meclinzine hydorchloride500 in 1 BOXTABLET, CHEWABLE5005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59961-125MECLINZINE HYDORCHLORIDE (MECLINZINE HYDROCHLORIDE - CHEWABLE) TABLET, CHEWABLE [BELLEGROVE MEDICAL SUPPLY, INC.]5Legacy NDC, 2 package rows20201103_9b50cae4-e10d-40d1-bad2-d8b53aee74fd.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59961-12559961-125-02, 59961-125-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
Meclizine hydrochlorideHDP7W44CIOACTIB
anhydrous lactose3SY5LH9PMKIACT

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
1109f809-f48b-4e0d-80a3-d786a6fd57239b50cae4-e10d-40d1-bad2-d8b53aee74fd2020-11-02WarningsExact identifier
spl id: 1109f809-f48b-4e0d-80a3-d786a6fd5723
spl set id: 9b50cae4-e10d-40d1-bad2-d8b53aee74fd

Reported adverse events (FAERS/openFDA)#

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