Otc - Active Ingredient
EACH TABLET CONTAINS DIMENHYDRINATE 50 MG
Dimenhydrinate
FDA Label NDC 49483-352
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Time Cap Labs, Inc for the product Dimenhydrinate (NDC 49483-352). 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 otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, dosage & administration, warnings, indications & usage, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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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