FDA Label for Meclizine Hydrochloride
View Indications, Usage & Precautions
Meclizine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Northeast Pharma. 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.
Active Ingredient (In Each Tablet)
Meclizine HCI 25mg
Purpose
Antiemetic
Uses
For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizziness
Warnings
Do not use in children under 12 years of age unless directed by a doctor.
Ask a doctor before use if you have
• breathing problems, such as emphysema or chronic bronchitis
• glaucoma
• difficulty urinating due to an enlarged prostate gland
A sk a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
When using this product
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery
I
f pregnant or breast-feeding,ask a health professional before use.
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.
Directions
• to prevent motion sickness, take the first dose ½ hour to 1 hour before starting activity
• to treat motion sickness, take at first sign of symptoms
•
Adults and children 12 years of age and over: Take 1-2 tablets once daily, or as directed by a doctor.
Do not exceed 2 tablets in 24 hours.
Other Information
• TAMPER EVIDENT:Do not use if imprinted seal under cap is broken or missing.
• store at 20-25°C (68-77°F); excursions permitted between 15°-30°C (59°-86°F)
• protect from humidity
Inactive Ingredients
corn starch, D&C yellow #10 lake, lactose anhydrous, magnesium stearate, silicon dioxide.
Questions Or Comments?
1-800-540-3765
Package Label
* Please review the disclaimer below.