FDA Label for Dimenhydrinate
View Indications, Usage & Precautions
Dimenhydrinate Product Label
The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active ingredient (in each tablet)
Dimenhydrinate 50 mg
Otc - Purpose
Purpose
Antiemetic
Uses
for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness
Warnings
Do not give to children under 2 years of age unless directed by a doctor
Otc - Ask Doctor
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
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Otc - When Using
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
If pregnant or breast-feeding, ask a health professional before use.
.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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 rst 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 29 mg
■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
■ protect from moisture
■ see end -ap for expiration date and lot number
■ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
Inactive Ingredient
croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose
Questions Or Comments?
1-800-616-2471
Other
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Dramamine® Tablets.
Distributed by: MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA
Package Label.Principal Display Panel
MAJOR ®
NDC 0904-6772-12
Compare to the Active Ingredient in DRAMAMINE ® Original Formula*
Driminate TM
Dimenhydrinate USP, Antiemetic
For Nausea, Dizziness and Vomiting from Motion Sickness
12 Tablets 50mg Each
Use as Directed
* Please review the disclaimer below.