FDA.reportPublic FDA data

Meclizine HCl 25 mg Chewable Tablets

Manufacturer
Bryant Ranch Prepack
Effective date
2022-02-09
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:48:36

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

NDC: 71335-0143-1: 30 Tablets in a BOTTLE

NDC: 71335-0143-2: 20 Tablets in a BOTTLE

NDC: 71335-0143-3: 25 Tablets in a BOTTLE

NDC: 71335-0143-4: 40 Tablets in a BOTTLE

NDC: 71335-0143-5: 60 Tablets in a BOTTLE

NDC: 71335-0143-6: 90 Tablets in a BOTTLE

NDC: 71335-0143-7: 8 Tablets in a BOTTLE

NDC: 71335-0143-8: 14 Tablets in a BOTTLE

NDC: 71335-0143-9: 10 Tablets in a BOTTLE

NDC: 71335-0143-0: 120 Tablets in a BOTTLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Meclizine 25MG Chewable

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995632meclizine HCl 25 MG Chewable TabletPSN7
995632meclizine hydrochloride 25 MG Chewable TabletSCD7

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0143-02024-01-30C16284748780-11030e365-3ccc-111a-e063-dadaa90a10e2Meclizine HCl 25 mg Chewable Tablets
71335-0143-12024-01-30C16284748780-11030e365-3ccc-111a-e063-dadaa90a10e2Meclizine HCl 25 mg Chewable Tablets
71335-0143-22024-01-30C16284748780-11030e365-3ccc-111a-e063-dadaa90a10e2Meclizine HCl 25 mg Chewable Tablets
71335-0143-32024-01-30C16284748780-11030e365-3ccc-111a-e063-dadaa90a10e2Meclizine HCl 25 mg Chewable Tablets
71335-0143-42024-01-30C16284748780-11030e365-3ccc-111a-e063-dadaa90a10e2Meclizine HCl 25 mg Chewable Tablets
71335-0143-52024-01-30C16284748780-11030e365-3ccc-111a-e063-dadaa90a10e2Meclizine HCl 25 mg Chewable Tablets
71335-0143-62024-01-30C16284748780-11030e365-3ccc-111a-e063-dadaa90a10e2Meclizine HCl 25 mg Chewable Tablets
71335-0143-72024-01-30C16284748780-11030e365-3ccc-111a-e063-dadaa90a10e2Meclizine HCl 25 mg Chewable Tablets
71335-0143-82024-01-30C16284748780-11030e365-3ccc-111a-e063-dadaa90a10e2Meclizine HCl 25 mg Chewable Tablets
71335-0143-92024-01-30C16284748780-11030e365-3ccc-111a-e063-dadaa90a10e2Meclizine HCl 25 mg Chewable Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0143-0Meclizine HCl 25 mg120 in 1 BOTTLETABLET, CHEWABLE1207
71335-0143-1Meclizine HCl 25 mg30 in 1 BOTTLETABLET, CHEWABLE307
71335-0143-2Meclizine HCl 25 mg20 in 1 BOTTLETABLET, CHEWABLE207
71335-0143-3Meclizine HCl 25 mg25 in 1 BOTTLETABLET, CHEWABLE257
71335-0143-4Meclizine HCl 25 mg40 in 1 BOTTLETABLET, CHEWABLE407
71335-0143-5Meclizine HCl 25 mg60 in 1 BOTTLETABLET, CHEWABLE607
71335-0143-6Meclizine HCl 25 mg90 in 1 BOTTLETABLET, CHEWABLE907
71335-0143-7Meclizine HCl 25 mg8 in 1 BOTTLETABLET, CHEWABLE87
71335-0143-8Meclizine HCl 25 mg14 in 1 BOTTLETABLET, CHEWABLE147
71335-0143-9Meclizine HCl 25 mg10 in 1 BOTTLETABLET, CHEWABLE107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0143MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [BRYANT RANCH PREPACK]7Legacy NDC, 10 package rows20220304_a0d519ec-8a3d-4486-8364-e8ed40bef5cb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0143-0EA - Each71335-0143fedf6fec-f861-4122-ac10-2396796a6fc712024-04-05
71335-0143-1EA - Each71335-01433619d9a6-18d2-4de3-8d25-15057047278912022-11-07
71335-0143-2EA - Each71335-01436a957adb-0e5d-4642-993f-3d7cc352a7ee12022-11-07
71335-0143-3EA - Each71335-0143b3323381-4953-4af1-9c7b-6f1a2b0e2d3012022-11-07
71335-0143-4EA - Each71335-01436d3c6555-a6fa-4b12-b7a6-c3689382ddfc12022-11-07
71335-0143-6EA - Each71335-0143dfed786b-587e-43c4-a413-50aa250bbcec12022-11-07
71335-0143-7EA - Each71335-0143573b57e2-d747-4912-ac17-c2fda1ddc4ed12022-11-07
71335-0143-8EA - Each71335-01433274ca5b-d7bb-4276-a151-bdd5cda0c50012022-11-07
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
71335-014371335-0143-1, 71335-0143-2, 71335-0143-3, 71335-0143-4, 71335-0143-5, 71335-0143-6, 71335-0143-7, 71335-0143-8, 71335-0143-9, 71335-0143-0
51645-994

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB
ASPARTAMEZ0H242BBR1IACT
SUCROSEC151H8M554IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM SULFATE0YPR65R21JIACT
TRICALCIUM PHOSPHATEK4C08XP666IACT

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
1918e9e2-8022-49ec-81fd-a9eea1d94fd4a0d519ec-8a3d-4486-8364-e8ed40bef5cb2026-08-28WarningsExact identifier
spl set id: a0d519ec-8a3d-4486-8364-e8ed40bef5cb

Reported adverse events (FAERS/openFDA)#

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