Active Ingredient (In Each Tablet)
Dimenhydrinate 50 mg
Driminate Tablet
FDA Label NDC 0904-2051
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Driminate (NDC 0904-2051). 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 the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness
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
- alcohol, sedatives, and tranquilizers may increase drowsiness
- marked drowsiness may occur
- use caution when driving a motor vehicle or operating machinery
- avoid alcoholic beverages
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 (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 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; not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor |
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- protect from moisture
- see end flap for expiration date and lot number
Inactive Ingredients
croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silica gel, stearic acid
Questions Or Comments?
(800) 616-2471
Principal Display Panel
MAJOR®
NDC 0904-2051-12
Compare to the Active Ingredient in DRAMAMINE® Original Formula*
Driminate™
Dimenhydrinate USP, Antiemetic
For Nausea, Dizziness and Vomiting from Motion Sickness
12 Tablets
50 mg EACH
Use as Directed
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 Prestige Brands, Inc., owner of the registered trademark Dramamine® Original Formula.
50844 REV1115K19802
Distributed by MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA
Re-order No. 700466
M-17 Rev. 09/16
Major 44-198 (Driminate 1)
* Please review the disclaimer below.
