FDA.reportPublic FDA data

Meclizine

Manufacturer
Advanced Rx LLC | Pharbest Pharmaceuticals, Inc.
Effective date
2024-11-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:39:55

Label at a glance#

ProductMeclizine
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure9 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCl 25 mg

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 in children under 12 years of age unless directed by a doctor.

Do not take unless directed by a doctor if you have

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

Do not take this product if you aretaking sedatives or tranquilizers, without first consulting your doctor.

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • drowsiness may occures
  • 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 (1-800-222-1222)

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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°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 or comments?

OTC - QUESTIONS SECTION

call 1-800-630-8895, 8:30 am - 4.30 pm ET, Monday-Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 80513-421-02

*Compare to the active ingredient in Bonine ®

Meclizine HCl 25 mg

Raspberry Flavor

Antiemetic

• Motion Sickness 

• Vomiting

• Nausea

200 CHEWABLE TABLETS

*This product is not manufactured or distributed by WellSpring Pharmaceuticals Corporation., owner of the registered trademark Bonine ®

Distributed by:

ADVANCED RX LLC,

1942 NE 163rd St

North Miami Beach, FL 33162 U.S.A.

Manufactured in the USA

LabelLabel

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80513-421-02Meclizine200 in 1 BOTTLETABLET, CHEWABLE2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80513-421MECLIZINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [ADVANCED RX LLC]1Current NDC, 1 package rows20241202_b0a2a1f7-354e-48bd-9e98-9207bf9f53fd.zip

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
80513-42180513-421-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DEXTROSEIY9XDZ35W2IACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
STEARIC ACID4ELV7Z65APIACT
RASPBERRY4N14V5R27WIACT
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
MeclizineMECLIZINE HYDROCHLORIDEAdvanced Rx LLCb0a2a1f7-354e-48bd-9e98-9207bf9f53fd2024-11-27WarningsExact identifier
ndc (package): 80513-421-02
ndc (product): 80513-421
ndc11 (package): 80513042102
spl id: 27e17bc9-1e66-cc1f-e063-6394a90a4dcb
spl set id: b0a2a1f7-354e-48bd-9e98-9207bf9f53fd

Reported adverse events (FAERS/openFDA)#

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