Indications and uses
for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness
Dimenhydrinate
- Manufacturer
- LEADER/ Cardinal Health 110, Inc.
- Effective date
- 2026-02-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 01:46:48
Label at a glance#
ProductDimenhydrinate
Active ingredientDIMENHYDRINATE
Label structure10 sections
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 of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor ■ children 6 to under 12 years of age: 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor ■ children 2 to under 6 years ...
Contacts and useful links#
Websitewww.myleader.com
www.myleader.com
www.myleader.comLabel contents#
Full prescribing information#
Drug Facts
Active ingredient (in each tablet)
Dimenhydrinate 50 mg
OTC - PURPOSE SECTION
Purpose
Antiemetic
Uses
for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness
WARNINGS SECTION
Do not give to children under 2 years of age unless directed by a doctor
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
■ glaucoma
■ a breathing problem such as emphysema or chronic bronchitis
■ trouble urinating due to an enlarged prostate gland
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
■ marked drowsiness may occur
■ avoid alcoholic drinks
■ 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.
OVERDOSAGE SECTION
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor
■ children 6 to under 12 years of age: 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor
■ children 2 to under 6 years of age: 1/2 tablet every 6-8 hours; not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor
Other information
■ each tablet contains: calcium 30 mg
■ store in a dry place at 15° – 30°C (59° – 86°F)
■ protect from moisture
■ 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
INACTIVE INGREDIENT SECTION
croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose
Questions or comments?
1-800-231-4670
SPL UNCLASSIFIED SECTION
*This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine®
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
©2021 Cardinal Health. All Rights Reserved.
CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Essential to Care™ since 1979
All LEADER™ Brand
Products Have A
100%
Money Back
Guarantee
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LEADER
NDC 7000-0404-1
Original Formula
Motion Sickness Relief
Dimenhydrinate, 50 mg/ Antiemetic
COMPARE TO DRAMAMINE® ORIGINAL FORMULA active ingredient*
Fast Acting Motion Sickness Relief for Children & Adults
12 Tablets
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70000-0404-1 | Dimenhydrinate | 12 in 1 BLISTER PACK | TABLET | 12 | 7 | |
| 70000-0404-1 | Dimenhydrinate | 1 in 1 CARTON | TABLET | 1 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0404-1 | EA - Each | 70000-0404 | 6f2800c2-343e-46a1-8e47-6d7ca70df82d | 1 | 2019-08-06 |
Products#
Every source-derived product name is available through these pages.
- Dimenhydrinate
- CROSCARMELLOSE SODIUM
- CROSCARMELLOSE
- MAGNESIUM STEARATE
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
- CHLORTHEOPHYLLINE
- MICROCRYSTALLINE CELLULOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70000-0404 | 70000-0404-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | IACT |
| DIMENHYDRINATE | JB937PER5C | ACTIB |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dimenhydrinate | DIMENHYDRINATE | LEADER/ Cardinal Health 110, Inc. | 7c4adbdb-9bce-0c9c-e053-2a91aa0a8107 | 2026-02-20 | Warnings | 70000-0404-1 70000-0404 70000040401 4b4343e5-4d4d-6a4a-e063-6394a90ad2bc 7c4adbdb-9bce-0c9c-e053-2a91aa0a8107 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.