FDA.reportPublic FDA data

Travel-Ease

Manufacturer
Geri-Care Pharmaceutical Corp
Effective date
2023-10-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:57:54

Label at a glance#

ProductTravel-Ease
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizziness

Dosage and administration

take the first dose ½ hour to 1 hour before starting activity Adults and children 12 years of age and over: Take 1 to 2 tablets once daily, or as directed by a doctor. Do not exceed 2 tablets in 24 hours.

Storage and handling

• TAMPER EVIDENT: Do not use if imprinted seal under cap is broken or missing. • store at 20-25ºC (68-77ºF); excursions permitted between 15º-30ºC (59º-86ºF) • protect from heat and humidity

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCI 25mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizziness

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

• breathing problems, such as emphysema or chronic bronchitis

• glaucoma

• difficulty urinating due to an enlarged prostate gland

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

When using this product
• drowsiness may occur

• avoid alcoholic beverages

• alcohol, sedatives and tranquilizers may increase drowsiness

• use caution when driving a motor vehicle or operating machinery
I f 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 a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take the first dose ½ hour to 1 hour before starting activity
  • Adults and children 12 years of age and over: Take 1 to 2 tablets once daily, or as directed by a doctor.

Do not exceed 2 tablets in 24 hours.

Other information

STORAGE AND HANDLING SECTION

• TAMPER EVIDENT:Do not use if imprinted seal under cap is broken or missing.

• store at 20-25ºC (68-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

• protect from heat and humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, D&C yellow #10 lake, lactose monohydrate, magnesium stearate, pregelatinized starch.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995666meclizine HCl 25 MG Oral TabletPSN2
995666meclizine hydrochloride 25 MG Oral 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-378-01Travel-Ease100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-378TRAVEL-EASE (MECLIZINE HCL) TABLET [GERI-CARE PHARMACEUTICAL CORP]2Current NDC, Legacy NDC, 1 package rows20231026_e3c64eb9-4972-29d9-e053-2a95a90a2a8a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-378-01EA - Each57896-37885da75a8-b27a-4043-b3c9-032484abd32712023-02-06

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57896-37857896-378-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
MAGNESIUM STEARATE70097M6I30IACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
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
Travel-EaseMECLIZINE HCLGeri-Care Pharmaceutical Corpe3c64eb9-4972-29d9-e053-2a95a90a2a8a2023-10-25WarningsExact identifier
ndc (package): 57896-378-01
ndc (product): 57896-378
ndc11 (package): 57896037801
spl id: 088f57a1-ea8f-0807-e063-6294a90ab366
spl set id: e3c64eb9-4972-29d9-e053-2a95a90a2a8a

Reported adverse events (FAERS/openFDA)#

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