FDA.reportPublic FDA data

Motion Sickness Relief

Manufacturer
Shield Pharmaceuticals Corp
Effective date
2025-12-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:21:22

Label at a glance#

ProductMotion Sickness Relief
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

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

Dosage and administration

do not take more than directed take first dose ½ to 1 hour before starting activity adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each liquid-filled capsule)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not usefor children under 12 years of age unless directed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - DO NOT USE SECTION

taking sedatives or tranquilizers.

When using this product

OTC - STOP USE SECTION

  • drowsiness may occur n avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • 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 a Poison Control Center right away.1(800)222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • take first dose ½ to 1 hour before starting activity
  • adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor

Other information

OTHER SAFETY INFORMATION

  • TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • store at 25ºC (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 aluminum lake, lactose monohydrate, magnesium stearate, pregelatinized starch.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-373-6981 (toll-free)

SPL UNCLASSIFIED SECTION

Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Dramamine® Less Drowsy active ingredient†

LESS DROWSY FORMULA

Motion Sickness Relief

Meclizine HCl, 25 mg

Antiemetic
Helps prevent nausea and dizziness due to motion sickness

For Ages 12 and Over

Motion Sickness LabelMotion Sickness Label

Motion Sickness CartonMotion Sickness Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995666meclizine HCl 25 MG Oral TabletPSN6
995666meclizine hydrochloride 25 MG Oral TabletSCD6

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
83059-0007-1Motion Sickness Relief15 in 1 BOTTLETABLET, FILM COATED156
83059-0007-1Motion Sickness Relief1 in 1 PACKAGETABLET, FILM COATED16

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
83059-000783059-0007-1

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
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
STARCH, CORNO8232NY3SJIACT
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-10-31monthly-update2026-06-03 17:38:06
42024-12-26full-release2026-06-01 00:49:12

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
Motion Sickness ReliefMECLIZINE HCLShield Pharmaceuticals Corp9b5ad2ca-a47b-434a-97b5-8f729740d4ee2025-12-09WarningsExact identifier
ndc (package): 83059-0007-1
ndc (product): 83059-0007
ndc11 (package): 83059000701
spl id: 458baf7d-dea4-aa22-e063-6394a90a8ae5
spl set id: 9b5ad2ca-a47b-434a-97b5-8f729740d4ee

Reported adverse events (FAERS/openFDA)#

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