FDA.reportPublic FDA data

motion sickness

Manufacturer
Strategic Sourcing Services LLC | LNK International, Inc.
Effective date
2025-04-10
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 20:39:49

Label at a glance#

Productmotion sickness
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

to prevent motion sickness, take the first dose ½ hour to 1 hour before starting activity to treat motion sickness, take at first signs of symptoms adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) protect from heat and humidity see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

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 use

OTC - DO NOT USE SECTION

for children under 12 years of age unless directed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery

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 the first dose ½ hour to 1 hour before starting activity
  • to treat motion sickness, take at first signs of symptoms
  • adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from heat and humidity
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, silicon dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sunmark®

*COMPARE TO DRAMAMINE®
ALL DAY LESS DROWSY
ACTIVE INGREDIENT

NDC 70677-0026-1

Less Drowsy Formula
motion sickness
MECLIZINE HCl 25 mg
Antiemetic

Helps prevent • nausea • vomiting • dizziness
due to motion sickness for up to 24 hours

ACTUAL
SIZE

8 TABLETS

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

*This product is not manufactured or
distributed by Medtech Products Inc.,
owner of the registered trademark
Dramamine® All Day Less Drowsy.
50844        REV0219B40319

Distributed by McKesson Corp., via
Strategic Sourcing Services LLC,
Memphis, TN 38141
© 2003 McKesson Corporation
www.sunmarkbrand.com
Money Back Guarantee

Sunmark 44-403Sunmark 44-403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-0026MOTION SICKNESS (MECLIZINE HCL) TABLET [STRATEGIC SOURCING SERVICES LLC]9Legacy NDC20250411_48c29625-7ca9-4bcd-8481-475b538b8bae.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-0026-1EA - Each70677-0026b72d50b2-4881-42c1-af66-7fea9591bbdb12017-06-15

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
70677-002670677-0026-1

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
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB
STARCH, CORNO8232NY3SJIACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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
ba5e1972-e215-4f36-8f0d-7842f8a32a6248c29625-7ca9-4bcd-8481-475b538b8bae2025-04-10WarningsExact identifier
spl id: ba5e1972-e215-4f36-8f0d-7842f8a32a62
spl set id: 48c29625-7ca9-4bcd-8481-475b538b8bae

Reported adverse events (FAERS/openFDA)#

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