Active Ingredient (In Each Tablet)
Meclizine HCI 25mg
Travel-ease Tablet
FDA Label NDC 57896-378
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceutical Corp for the product Travel-ease (NDC 57896-378). 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, warnings, otc - 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
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
1 (Gc378)
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