Active Ingredient (In Each Tablet)
Dimenhydrinate 50 mg
Dimenhydrinate
FDA Label NDC 68151-1712
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Carilion Materials Management for the product Dimenhydrinate (NDC 68151-1712). 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, ask a doctor before use if you have, when using this product, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiemetic
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
When Using This Product
- marked drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).
Directions
- to prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity
- to prevent or treat motion sickness, use the following dosing
adults and children 12 years and over
| 1-2 tablets every 4-6 hours; not more than 8 tablets in 24 hours, or as directed by a doctor
|
children 6 years to under 12 years
| 1/2-1 tablet every 6-8 hours; not more than 3 tablets in 24 hours, or as directed by a doctor
|
children 2 years to under 6 years
| 1/4-1/2 tablet every 6-8 hours; not more than 1 1/2 tablets in 24 hours, or as directed by a doctor
|
Other Information
store at 15° to 30°C (59° to 86°F)
You may report serious side effects to: . 130 Vintage Drive, Huntsville, AL 35811
Inactive Ingredients
colloidal silicone dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid
* Please review the disclaimer below.
