FDA.reportPublic FDA data

Motion Sickness Relief

Manufacturer
Cardinal Health | LNK International, Inc.
Effective date
2021-03-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 22:49:21

Label at a glance#

ProductMotion Sickness Relief
Active ingredientDIMENHYDRINATE
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, the first dose should be taken one-half to one hour before starting activity adults and children 12 years and over    1 to 2 tablets every 4-6 hours; do not exceed   8 tablets in 24 hours, or as directed by a  doctor children 6 to under 12 years  1/2 to 1 tablet every 6-8 hours; do not exceed  3 tablets in 24 hours, or as directed by a  doctor  children 2 to under 6 years  1/2 tablet ev...

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 moisture see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Dimenhydrinate 50 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 2 years of age unless directed by a doctor.

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 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

  • avoid alcoholic beverages
  • marked drowsiness may occur
  • 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 (1-800-222-1222) right away. 

Directions

DOSAGE & ADMINISTRATION SECTION

  • to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity
adults and
children 12
years and over  		 1 to 2 tablets every 4-6 hours; do not exceed 
 8 tablets in 24 hours, or as directed by a
 doctor
children 6 to
under 12 years		 1/2 to 1 tablet every 6-8 hours; do not exceed
 3 tablets in 24 hours, or as directed by a
 doctor 
children 2 to
under 6 years		 1/2 tablet every 6-8 hours; do not exceed 1 1/2
 tablets in 24 hours, 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 moisture
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silica gel, stearic acid 

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70000-0250-1

Motion Sickness Relief
Dimenhydrinate, 50 mg | Antiemetic

Fast acting
Relief of Motion Sickness
for Children & Adults

12 TABLETS

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

All LEADER™ Brand Products Have A
100% Money Back Guarantee
Return to place of purchase if not satisfied.

*This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine®.

50844 ORG111519802

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

www.myleader.com     1-800-200-6313
Essential to Care™ since 1979

©2017 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.

Leader 44-198
Leader 44-198

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0250-1EA - Each70000-02509fc77690-1568-4d39-a02e-3025a62cb66312017-11-06

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-025070000-0250-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMENHYDRINATEJB937PER5CACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d298707c-50e6-4ef5-a6c7-671791c301ff77b55f4c-2da1-4043-97b2-497bccec59742022-04-08WarningsExact identifier
spl set id: 77b55f4c-2da1-4043-97b2-497bccec5974

Reported adverse events (FAERS/openFDA)#

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