FDA.reportPublic FDA data

Motion-Time

Manufacturer
RedPharm Drug, Inc.
Effective date
2021-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:36:53

Label at a glance#

ProductMotion-Time Chewable
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure13 sections

Storage and handling

Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) in a dry place use by expiration date on package

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Meclizine HCl 25 mg

OTC - PURPOSE SECTION

Purpose

Antiemetic

INDICATIONS & USAGE SECTION

Uses

prevents and treats nausea, vomiting, or dizziness associated with motion sickness

WARNINGS SECTION

Warnings

Do not give to children under 12 years of age unless directed by a doctor

OTC - ASK DOCTOR SECTION

Do not take unless directed by a doctor if you have

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis

OTC - DO NOT USE SECTION

Do not take if you are

taking sedatives or tranquilizers, without first consulting your doctor

OTC - WHEN USING SECTION

When using this product

  • do not exceed recommended dosage
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful 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 a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • dosage should be taken one hour before travel starts
  • adults and children 12 years of age and over: take 1 to 2 tablets once daily or as directed by a doctor

STORAGE AND HANDLING SECTION

Other information

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) in a dry place
  • use by expiration date on package

INACTIVE INGREDIENT SECTION

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, crospovidone, dextrose, FD-C red 40 aluminum lake, magnesium stearate, microcrystalline cellulose, modified corn starch, propylene glycol, raspberry flavor, silicon dioxide, sodium saccharin, stearic acid, talc, vanilla flavor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

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
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1626-32023-01-30C16284748780-1f386c649-9bdd-0266-e053-dadaa90a7c1aMECLIZINE 25MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1626-3Motion-TimeChewable30 in 1 BOTTLETABLET, CHEWABLE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1626MOTION-TIME CHEWABLE (MECLIZINE HCL) TABLET, CHEWABLE [REDPHARM DRUG, INC.]2Legacy NDC, 1 package rows20210114_888c83ef-5392-662b-e053-2a95a90a9682.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-333-01EA - Each49483-3335957c9df-76dd-47c7-ace2-e934cba6452012015-10-02
49483-333-10EA - Each49483-3339dd91377-941f-482b-8de6-82ccff7eae6812014-11-05
49483-333-16EA - Each49483-333718164ca-5635-48af-8f0d-a755a997b94912015-10-02

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67296-162667296-1626-3
49483-333

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS LACTOSE3SY5LH9PMKIACT
CROSPOVIDONE68401960MKIACT
DEXTROSEIY9XDZ35W2IACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
RASPBERRY4N14V5R27WIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
VANILLAQ74T35078HIACT
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB

Source Document#

Source XML · Source PDF

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b8d0902d-38fc-44a0-e053-2995a90a5c32888c83ef-5392-662b-e053-2a95a90a96822021-01-13WarningsExact identifier
spl id: b8d0902d-38fc-44a0-e053-2995a90a5c32
spl set id: 888c83ef-5392-662b-e053-2a95a90a9682
Motion-Time ChewableMECLIZINE HCLTime-Cap Labs, Inc7f3ce1e6-c0d6-4b56-8f7a-6368eb46901f2018-12-17WarningsExact identifier
ndc (product): 49483-333

Reported adverse events (FAERS/openFDA)#

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