FDA.reportPublic FDA data

MECLIZINE

Manufacturer
Bryant Ranch Prepack
Effective date
2019-06-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:40

Label at a glance#

ProductMECLIZINE
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

prevents and treats nausea, vomiting or dizziness associated with motion sickness

Dosage and administration

doage should be taken 1 hour before travel starts   Adults and children 12 years and over take 1 or 2 tablets once daily or as directed by doctor

Storage and handling

Tamper Evident: do not use if safety seal under cap is broken or missing store at room temperature 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCl 25mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

prevents and treats nausea, vomiting or dizziness associated with motion sickness

Warnings

WARNINGS SECTION

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

Do not take unless directed by a doctor if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • doage should be taken 1 hour before travel starts  
Adults and children 12 years and over

take 1 or 2 tablets once daily or as directed by doctor

Other information

STORAGE AND HANDLING SECTION

  • Tamper Evident: do not use if safety seal under cap is broken or missing
  • store at room temperature 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Croscarmellose sodium, dextrose, FD&C Red#40, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid

Questions?

OTC - QUESTIONS SECTION

Adverse drug event call (800) 687-0176 (M - F, 8AM - 4PM EST).

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 71335-1215

NDC: 71335-1215-0 120 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-1 30 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-2 20 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-3 25 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-4 40 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-5 60 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-6 90 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-7 8 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-8 14 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-9 10 TABLET, CHEWABLE in a BOTTLE

Meclizine 25MG Chewable

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995632meclizine HCl 25 MG Chewable TabletPSN1
995632meclizine hydrochloride 25 MG Chewable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1215-0MECLIZINE120 in 1 BOTTLETABLET, CHEWABLE1201
71335-1215-1MECLIZINE30 in 1 BOTTLETABLET, CHEWABLE301
71335-1215-2MECLIZINE20 in 1 BOTTLETABLET, CHEWABLE201
71335-1215-3MECLIZINE25 in 1 BOTTLETABLET, CHEWABLE251
71335-1215-4MECLIZINE40 in 1 BOTTLETABLET, CHEWABLE401
71335-1215-5MECLIZINE60 in 1 BOTTLETABLET, CHEWABLE601
71335-1215-6MECLIZINE90 in 1 BOTTLETABLET, CHEWABLE901
71335-1215-7MECLIZINE8 in 1 BOTTLETABLET, CHEWABLE81
71335-1215-8MECLIZINE14 in 1 BOTTLETABLET, CHEWABLE141
71335-1215-9MECLIZINE10 in 1 BOTTLETABLET, CHEWABLE101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1215MECLIZINE (MECLIZINE HCL 25MG) TABLET, CHEWABLE [BRYANT RANCH PREPACK]1Current NDC, Legacy NDC, 10 package rows20190614_623db9de-4224-47ce-84b7-6eaefe97290e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1215-1EA - Each71335-1215e766e90b-04e4-4a08-9f77-c0c195f01e2512019-12-10

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71335-121571335-1215-0, 71335-1215-1, 71335-1215-2, 71335-1215-3, 71335-1215-4, 71335-1215-5, 71335-1215-6, 71335-1215-7, 71335-1215-8, 71335-1215-9
66424-387

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
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
STEARIC ACID4ELV7Z65APIACT

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
MECLIZINEMECLIZINE HCL 25MGBryant Ranch Prepack623db9de-4224-47ce-84b7-6eaefe97290e2019-06-13WarningsExact identifier
ndc (package): 71335-1215-3
ndc (package): 71335-1215-8
ndc (package): 71335-1215-2
ndc (package): 71335-1215-4
ndc (package): 71335-1215-0
ndc (package): 71335-1215-6
ndc (package): 71335-1215-5
ndc (package): 71335-1215-9
ndc (package): 71335-1215-7
ndc (package): 71335-1215-1
ndc (product): 71335-1215
ndc11 (package): 71335121509
ndc11 (package): 71335121507
ndc11 (package): 71335121505
ndc11 (package): 71335121503
ndc11 (package): 71335121500
ndc11 (package): 71335121502
ndc11 (package): 71335121506
ndc11 (package): 71335121501
ndc11 (package): 71335121504
ndc11 (package): 71335121508
spl id: dc78e0fc-fccc-45a2-a33b-2a2eeb5caab9
spl set id: 623db9de-4224-47ce-84b7-6eaefe97290e

Reported adverse events (FAERS/openFDA)#

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