FDA.reportPublic FDA data

Meclizine

Manufacturer
PHARMAMED USA INC | PHARBEST PHARMACEUTICALS, INC.
Effective date
2024-06-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:22:17

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 doctor

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 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

OTC - DO NOT USE SECTION

  • 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

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

Other information

OTHER SAFETY INFORMATION

  • Tamper Evident: do not use if the safety seal under cap is broken or missing
  • store at 20°-25°C (68°-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, 8AM - 4PM EST)

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARMAMED

NDC 84289-387-01

Manufactured in the USA

Chewable, Once-A-Day Protection

MECLIZINE

Antiemetic

100 CHEWABLE TABLETS

Meclizine HCL 25mg

Raspberry Flavor

*Compare to the active ingredient in Bonine

Label ImageLabel Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995632meclizine HCl 25 MG Chewable TabletPSN2
995632meclizine hydrochloride 25 MG Chewable TabletSCD2

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
84289-387-01Meclizine100 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84289-387MECLIZINE (MECLIZINE HCL 25MG) TABLET, CHEWABLE [PHARMAMED USA INC]21 package rows20241001_1b2f80d7-cee3-1283-e063-6394a90abc4b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-387-08EA - Each16103-3873442d87d-ab37-4744-91ee-2186d8cf33ef12019-04-11
16103-387-11EA - Each16103-3875ff12391-bd24-4d54-bf8e-094ee2d6b49712021-03-02

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84289-38784289-387-01
16103-387

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
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DEXTROSEIY9XDZ35W2IACT
STEARIC ACID4ELV7Z65APIACT
MAGNESIUM STEARATE70097M6I30IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
FD&C RED NO. 40WZB9127XOAIACT
RASPBERRY4N14V5R27WIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MECLIZINEMECLIZINE HCL 25MGPharbest Pharmaceuticals, Inc.4bac2765-045c-405e-8006-8c5cfdfa89bc2025-12-24WarningsExact identifier
ndc (product): 16103-387
1bcfde17-1d77-6eeb-e063-6394a90abf011b2f80d7-cee3-1283-e063-6394a90abc4b2024-06-26WarningsExact identifier
spl id: 1bcfde17-1d77-6eeb-e063-6394a90abf01
spl set id: 1b2f80d7-cee3-1283-e063-6394a90abc4b

Reported adverse events (FAERS/openFDA)#

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