FDA.reportPublic FDA data

MECLIZINE HYDROCHLORIDE CHEWABLE TABLETS, 25 MG

Manufacturer
BluePoint Laboratories | Unique Pharmaceutical Laboratories
Effective date
2024-02-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:08:51

Label at a glance#

ProductMeclizine HCl
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure13 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 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

Phenylketonurics: Contains Phenylalanine 0.0025 mg per tablet Store at room temperature in a dry place Keep lid tightly closed

Label contents#

Full prescribing information#

Drug Facts Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCl, USP 25 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

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.

When using this product

OTC - WHEN USING SECTION

  • 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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 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

  • Phenylketonurics: Contains Phenylalanine 0.0025 mg per tablet
  • Store at room temperature in a dry place
  • Keep lid tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

aspartame, colloidal silicon dioxide, croscarmellose sodium, dextrose, lake of FD & C Red 40, magnesium stearate, maltodextrin, microcrystalline cellulose, raspberry flavor, sodium sulfate anhydrous, sucrose, tribasic calcium phosphate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-844-474-7464 Monday to Friday 8 AM - 5 PM ET

PRINCIPAL DISPLAY PANEL - 25 mg Chewable Tablet Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Meclizine Hydrochloride Chewable Tablets

25 mg

100 Tablets / 1000 tablets

label count 100label count 100label 1000label 1000

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
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-529-00Meclizine HCl100 in 1 BOTTLETABLET, CHEWABLE1002
68001-529-08Meclizine HCl1000 in 1 BOTTLETABLET, CHEWABLE10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-529MECLIZINE HCL (MECLIZINE HYDROCHLORIDE CHEWABLE) TABLET, CHEWABLE [BLUEPOINT LABORATORIES]2Current NDC, Legacy NDC, 2 package rows20240222_d9cc2705-9dcc-0a73-e053-2995a90aafe6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-529-00EA - Each68001-5290e17c453-0e76-44a8-be97-86850ebbce9212022-04-06
68001-529-08EA - Each68001-529392cc8fc-6d12-4f6d-9668-d9477ef4a44912022-04-06

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68001-52968001-529-00, 68001-529-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPARTAMEZ0H242BBR1IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SODIUM SULFATE ANHYDROUS36KCS0R750IACT
SUCROSEC151H8M554IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DEXTROSEIY9XDZ35W2IACT
MALTODEXTRIN7CVR7L4A2DIACT
RASPBERRY4N14V5R27WIACT
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB

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
Meclizine HClMECLIZINE HYDROCHLORIDE CHEWABLEBluePoint Laboratoriesd9cc2705-9dcc-0a73-e053-2995a90aafe62024-02-21WarningsExact identifier
ndc (package): 68001-529-08
ndc (package): 68001-529-00
ndc (product): 68001-529
ndc11 (package): 68001052900
ndc11 (package): 68001052908
spl id: 11d28658-55a1-ff25-e063-6394a90a7e65
spl set id: d9cc2705-9dcc-0a73-e053-2995a90aafe6

Reported adverse events (FAERS/openFDA)#

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