FDA.reportPublic FDA data

MECLIZINE

Manufacturer
Ulai Health LLC | Pharbest Pharmaceuticals, Inc.
Effective date
2019-07-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:54

Label at a glance#

ProductMECLIZINE
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

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

Dosage and administration

dosage should be taken one hour before travel starts adults and children 12 years and over take 1 or 2 tablets once daily or as directed by a doctor 

Storage and handling

store at 20 o -25°C (68 o -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

Do not use

OTC - DO NOT USE SECTION

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

Do not take this product, 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 are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use causion 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

  • dosage should be taken one hour before travel starts
adults and children 12 years and overtake 1 or 2 tablets once daily or as directed by a doctor 

Other information

STORAGE AND HANDLING SECTION

  • store at 20o-25°C (68o-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARBEST

NDC 73057-387-11

Manufactured in the USA

Chewable, Once-A-Day Protection

*Compare to the active ingredient in Bonine®

MECLIZINE

CHEWABLE

Raspberry Flavor

Meclizine HCl 25mg

Antiemetic

• Motion Sickness • Nausea • Vomiting

1000 TABLETS

Ulai Meclizine 25 mg tablet 1000 ct. LabelUlai Meclizine 25 mg tablet 1000 ct. Label

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73057-387-082022-01-28C16284748780-1d6a99b39-507a-a426-e053-dadaa90af4c2Drug Facts
73057-387-112022-01-28C16284748780-1d6a99b39-507a-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73057-387-08MECLIZINE100 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1001
73057-387-11MECLIZINE1000 in 1 BOTTLE, PLASTICTABLET, CHEWABLE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73057-387MECLIZINE (MECLIZINE HCL 25MG) TABLET, CHEWABLE [ULAI HEALTH LLC]1Legacy NDC, 2 package rows20190723_ea2e6834-c11a-40f8-887c-e02419023e7b.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
73057-38773057-387-11, 73057-387-08

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
DEXTROSEIY9XDZ35W2IACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
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
3c884e11-5f9b-4a8a-9a2b-179a19b20244ea2e6834-c11a-40f8-887c-e02419023e7b2019-07-22WarningsExact identifier
spl id: 3c884e11-5f9b-4a8a-9a2b-179a19b20244
spl set id: ea2e6834-c11a-40f8-887c-e02419023e7b

Reported adverse events (FAERS/openFDA)#

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