Otc - Active Ingredient
Active ingredient (in each tablet)
Meclizine hydrochloride 25mg
Cvs Motion Sickness Fast Melting Tablet, Orally Disintegrating
FDA Label NDC 59779-534
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Cvs Motion Sickness Fast Melting (NDC 59779-534). 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, otc - purpose, indications & usage, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Meclizine hydrochloride Antiemetic
Indications & Usage
Uses
■ For the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness.
Otc - Do Not Use
Do not use in children under 12 years of age unless directed by a physician
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 enlargement of the prostate gland
Otc - Ask Doctor/Pharmacist
Ask a physician or pharmacist before use if you are
■ taking sedatives or tranquilizers
Otc - When Using
When using this product
■ you may get drowsy ■ avoid alcoholic beverages
■ be careful when driving a motor vehicle or operating machinery
■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect
Otc - Pregnancy Or Breast Feeding
If 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.
Dosage & Administration
Directions
To prevent motion sickness take it at least one hour before traveling
Adults and children 12 years of age and over: take 1 to 2 (25 to 50 mg) tablets once daily, or as directed by a physician.
Other Safety Information
Other information
■ Store at 20-30°C (68-86°F)
Inactive Ingredient
Inactive ingredients
acesulfame potassium, erythritol, hydroxypropyl cellulose, colloidal silicon dioxide, mannitol, menthol, sodium stearyl fumarate, yellow ferric oxide.
Package Label.Principal Display Panel
Carton (Cvsmotcart)
* Please review the disclaimer below.
