Active Ingredient (In Each Tablet)
Dimenhydrinate 50 mg
Motion Sickness Relief Tablet
FDA Label NDC 70000-0749
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Motion Sickness Relief (NDC 70000-0749). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiemetic
Uses
for prevention and treatment of these symptoms associated with motion sickness:
- nausea
- vomiting
- dizziness
Do Not Use
for children under 2 years of age unless directed by a doctor.
Ask A Doctor Before Use If You Have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- marked 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,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- 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 | ½ 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 | ½ tablet every 6-8 hours; do not exceed 1½ tablets in 24 hours, or as directed by a doctor |
Other Information
- each tablet contains: calcium 35 mg
- see end flap for expiration date and lot number
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- protect from moisture
Inactive Ingredients
croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid
Questions Or Comments?
1-800-426-9391
Principal Display Panel
NDC 70000-0749-1
LEADER™
Original Formula
Motion Sickness Relief
Dimenhydrinate, 50 mg | Antiemetic
Prevents Nausea,
Vomiting & Dizziness
for Children & Adults
12 TABLETS
Actual Size
COMPARE TO
DRAMAMINE®
ORIGINAL FORMULA
active ingredient*
100% Money Back Guarantee
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® Original Formula.
50844 ORG051819802
100%
Money Back
Guarantee
Return to place of purchase.
CardinalHealth™
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Essential to Care™ since 1979
©2025 Cardinal Health. All Rights
Reserved. CARDINAL HEALTH, the
Cardinal Health LOGO, ESSENTIAL TO
CARE, LEADER, and the LEADER LOGO
are trademarks or registered
trademarks of Cardinal Health. All
other marks are the property of their
respective owners.
Leader 44-198 (Leader 44 198 1)
* Please review the disclaimer below.
