Meclizine HCl 25 mg Chewable Tablets

Manufacturer
Unit Dose Services
Effective date
2021-09-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:42:29

Label at a glance#

ProductMeclizine HCl 25 mg
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure18 sections

Storage and handling

Other information phenylketonurics: contains phenylalanine 0.28 mg per tablet store at room temperature in a dry place

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each chewable tablet)

Meclizine HCl, USP 25 mg

OTC - PURPOSE SECTION

Purpose

Antiemetic

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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 SECTION

Other information

  • phenylketonurics: contains phenylalanine 0.28 mg per tablet
  • store at room temperature in a dry place

INACTIVE INGREDIENT SECTION

Inactive ingredients 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.

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by: Plus Pharma, Commack, NY 11725

*Plus Pharma is not affiliated with the owner of the registered trademark Bonine®.

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50436-0994

NDC: 50436-0994-1 30 TABLET, CHEWABLE in a BOTTLE

MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, 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 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0994-1Meclizine HCl 25 mg30 in 1 BOTTLETABLET, CHEWABLE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0994MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [UNIT DOSE SERVICES]4Legacy NDC, 1 package rows20210923_ff14ae8b-bc67-4f79-958a-c2d968bfcc30.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0994-1EA - Each50436-0994b74923d8-ecca-4f74-ae23-330057ba131012021-10-08
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
50436-099450436-0994-1
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
402427ef-1da7-48c7-84d0-982e25cf0c8bff14ae8b-bc67-4f79-958a-c2d968bfcc302021-09-22WarningsExact identifier
spl id: 402427ef-1da7-48c7-84d0-982e25cf0c8b
spl set id: ff14ae8b-bc67-4f79-958a-c2d968bfcc30

Reported adverse events (FAERS/openFDA)#

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