FDA.reportPublic FDA data

ZenTrip Motion Sickness (12 Tablets - 25mg each)

Manufacturer
Sato Pharmaceutical Co., LTD
Effective date
2023-11-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:58:48

Label at a glance#

ProductZenTrip Motion Sickness
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

for the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness

Dosage and administration

to prevent motion sickness, take it at least one hour before traveling adults and children 12 years of age and over: take 1 to 2 tablets (25 to 50mg) once daily, or as directed by a physician.

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine hydrochloride 25mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

  • for the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness

Warnings

WARNINGS SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

Ask a physician or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • you may get drowsy
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • to prevent motion sickness, take it at least one hour before traveling
  • adults and children 12 years of age and over: take 1 to 2 tablets (25 to 50mg) once daily, or as directed by a physician.

Other information

OTHER SAFETY INFORMATION

  • store at 20-30°C (68-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, erythritol, hydroxypropyl cellulose, mannitol, menthol, silicon dioxide colloidal, sodium stearyl fumarate, and yellow ferric oxide.

ZenTrip Motion Sickness - 12Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZenTrip Motion Sickness - 12TabletsZenTrip Motion Sickness - 12Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1663815meclizine HCl 25 MG Disintegrating Oral TabletPSN3
2540687ZenTrip 25 MG Disintegrating Oral TabletPSN3
2540687meclizine hydrochloride 25 MG Disintegrating Oral Tablet [Zentrip]SBD3
1663815meclizine hydrochloride 25 MG Disintegrating Oral TabletSCD3
1663815meclizine HCl 25 MG Disintegrating Oral TabletSY3
2540687Zentrip 25 MG Disintegrating Oral TabletSY3

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49873-805-012023-04-14C16284748780-1f386c64a-3393-0266-e053-dadaa90a7c1aZenTrip Motion Sickness (12 Tablets - 25mg each)
49873-805-012023-01-30C16284748780-1f386c64a-3393-0266-e053-dadaa90a7c1aZenTrip Motion Sickness (12 Tablets - 25mg each)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-805-01ZenTrip Motion Sickness2 in 1 BOXTABLET23
49873-805-01ZenTrip Motion Sickness6 in 1 BLISTER PACKTABLET63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-805ZENTRIP MOTION SICKNESS (MECLIZINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD]3Current NDC, Legacy NDC, 2 package rows20231104_bd86c4c7-b6f0-e3e8-e053-2995a90a4454.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49873-80549873-805-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACESULFAME POTASSIUM23OV73Q5G9IACT
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB
MANNITOL3OWL53L36AIACT
MENTHOLL7T10EIP3AIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ERYTHRITOLRA96B954X6IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PIACT

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
ZenTrip Motion SicknessMECLIZINE HYDROCHLORIDESato Pharmaceutical Co., LTDbd86c4c7-b6f0-e3e8-e053-2995a90a44542023-11-03WarningsExact identifier
ndc (package): 49873-805-01
ndc (product): 49873-805
ndc11 (package): 49873080501
spl id: 0949e5cb-b9e4-cee1-e063-6394a90a5377
spl set id: bd86c4c7-b6f0-e3e8-e053-2995a90a4454

Reported adverse events (FAERS/openFDA)#

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