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 Time Cap Labs, Inc. 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.
Otc - Active Ingredient
EACH TABLET CONTAINS DIMENHYDRINATE 50 MG
Inactive Ingredient
COLLOIDAL SILICON DIOXIDE, CROSCARMELLOSE SODIUM,HYPROMELLOSE, AHNYDROUS LACTOSE, MAGNESIUM STEARATE, CELLULOSE, MICROCRYSTALLINE, MINEROL
Otc - Purpose
Antiemetic
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away
Dosage & Administration
irections:
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 to 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 to 8 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor
Children 2 to under 6 years of age - 1/4 to 1/2 tablet every 6 to 8 hours,not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor
Warnings
Warnings
Do not use for children under 2 years of age unless directed by a doctor
Indications & Usage
Use
for prevention and treatment of these symptoms associated with motion sickness:
nauseavomitingdizziness
Otc - Ask Doctor
Ask a doctor before use if you have glaucoma; a breathing problem such as emphysema or chronic bronchitis; difficulty in urination due to an enlargement of the 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: do not exceed recommended dosage; marked drowsiness may occur; avoid alcoholic drinks; alcohol, sedatives, and tranquilizers may increase drowsiness. Be careful when driving a motor vehicle or operating machinery.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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