Meclizine HCl 25 mg

Manufacturer
RedPharm Drug, Inc.
Effective date
2020-01-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:03:18

Label at a glance#

ProductMeclizine HCl 25 mg
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure17 sections

Indications and uses

prevents and treats nausea, vomiting or dizziness due to motion sickness

Dosage and administration

Dosage should be taken one hour before travel starts. Adults and children 12 years of age and older: Chew 1-2 tablets once daily or as directed by a doctor Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor.

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH CHEWABLE TABLET)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCl, USP 25 mg

PURPOSE

OTC - PURPOSE SECTION

Antiemetic

USES

SPL UNCLASSIFIED SECTION

prevents and treats nausea, vomiting or dizziness due to motion sickness

WARNINGS

WARNINGS SECTION

WARNINGS

DO NOT USE

OTC - DO NOT USE SECTION

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

ASK DOCTOR

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

ASK DOCTOR/PHARMACIST

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

PREGNANCY OR BREAST FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of overdose, get medical help or contact the poison control center immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Dosage should be taken one hour before travel starts.
Adults and children 12 years of age and older: Chew 1-2 tablets once daily or as directed by a doctor
Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

store at room temperature

OTHER SAFETY INFORMATION

Phenylketonurics: Contains phenylalanine 0.28 mg per tablet
Do not use if imprinted safety seal under cap is broken or missing

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

aspartame, croscarmellose sodium, dextrose, FD&C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.

WHEN USING

OTC - WHEN USING SECTION

When using this product

may cause drowsiness
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
use caution when driving a motor vehicle or operating machinery

PURPOSE

INDICATIONS & USAGE SECTION

Antiemetic

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

meclizine 25mgmeclizine 25mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995632meclizine HCl 25 MG Chewable TabletPSN4
995632meclizine hydrochloride 25 MG Chewable TabletSCD4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1390-32022-01-28C16284748780-1d6a99b39-5192-a426-e053-dadaa90af4c2505f6036-d216-4455-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1390-3Meclizine HCl 25 mg30 in 1 BOTTLETABLET, CHEWABLE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1390MECLIZINE HCL 25 MG TABLET, CHEWABLE [REDPHARM DRUG, INC.]4Legacy NDC, 1 package rows20200121_505f6036-d216-4455-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51645-994-01EA - Each51645-994094ec1d6-7d2f-47b2-bfba-42e4d43dd5be12016-03-04
51645-994-10EA - Each51645-9941e7b29ee-6984-4e20-aacf-83d5b646caee12016-03-04

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67296-139067296-1390-3
51645-994

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
9c9f9369-30eb-3cec-e053-2a95a90a8cef505f6036-d216-4455-e054-00144ff88e882020-01-20WarningsExact identifier
spl id: 9c9f9369-30eb-3cec-e053-2a95a90a8cef
spl set id: 505f6036-d216-4455-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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