FDA.reportPublic FDA data

Meclizine HCL

Manufacturer
Richmond Pharmaceuticals, Inc. | Advance Pharmaceutical Inc.
Effective date
2017-10-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:52:49

Label at a glance#

ProductMeclizine HCL
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness. For other uses consult your doctor

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Meclizine Hydrochloride 25 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness. For other uses consult your doctor

Warnings

WARNINGS SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Phenylketonurics:
each tablet contains:
phenylalanine 0.28 mg
store at room temparature 15 - 30 °C

Questions or Comments

OTC - QUESTIONS SECTION

Call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red 40 (al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC :  54738-025-01- 100 CHEW TABS

NDC : 54738-025-03- 1000 CHEW TABS

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995632meclizine HCl 25 MG Chewable TabletPSN3
995632meclizine hydrochloride 25 MG Chewable TabletSCD3

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130054738025019GTIN-13: 0054738025019
EAN-13: 0054738025019
GTIN-12: 054738025019
UPC-A: 054738025019
GTIN storage (14 digits): 00054738025019		IMG_4677.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54738-025-01Meclizine HCL100 in 1 BOTTLETABLET, CHEWABLE1003
54738-025-03Meclizine HCL1000 in 1 BOTTLETABLET, CHEWABLE10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-025MECLIZINE HCL (MECLIZINE HCL 25MG CHEWABLE TABLETS) TABLET, CHEWABLE [RICHMOND PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20171030_98e3fe5a-73c6-4dcc-b397-cc6013beee43.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-025-01EA - Each54738-025e50d07ed-44a7-4675-b13c-cba61d32d66d12019-08-06
54738-025-03EA - Each54738-0252649f479-e975-427d-9743-9c119120abba12017-11-06

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54738-02554738-025-01, 54738-025-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPARTAMEZ0H242BBR1IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DEXTROSEIY9XDZ35W2IACT
FD&C RED NO. 40WZB9127XOAIACT
RASPBERRY4N14V5R27WIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SUCROSEC151H8M554IACT
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB

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
Meclizine HCLMECLIZINE HCL 25MG CHEWABLE TABLETSRichmond Pharmaceuticals, Inc.98e3fe5a-73c6-4dcc-b397-cc6013beee432017-10-30WarningsExact identifier
ndc (package): 54738-025-01
ndc (package): 54738-025-03
ndc (product): 54738-025
ndc11 (package): 54738002501
ndc11 (package): 54738002503
spl id: 5cc4c45d-5b77-0912-e053-2991aa0a10a5
spl set id: 98e3fe5a-73c6-4dcc-b397-cc6013beee43

Reported adverse events (FAERS/openFDA)#

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