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 Apnar Pharma Lp. 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
Active ingredient (in each tablet)
Meclizine HCL 25 mg
Otc - Purpose
Purpose
Antiemetic
Indications & Usage
Uses
For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizziness
Warnings
Warnings
Do not use in children under 12 years of age unless directed by a doctor.
Ask a doctor before use if you have
• glaucoma
• breathing problems, such as emphysema or chronic bronchitis
• difficulty urinating due to an enlarged prostate gland
Ask 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
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 the first dose one hour before starting activity
- not for frequent or prolonged use except on the advice of a doctor
- do not exceed recommended dose
Adults and children 12 years of age and older: Take 1-2 tablets once daily, or as directed by a doctor. Do not exceed 2 tablets in 24 hours.
Storage And Handling
Other information
- store at room temperature 15˚-30˚C (59˚-86˚F)
- protect from humidity
Inactive Ingredient
Inactive ingredients: D&C yellow # 10 lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide.
Otc - Questions
Questions or Comments?
Call 1-855-642-2594
Boxed Warning
Tamper evident:Do not use if safety seal is broken or missing
Other
Comapre to active ingredient in DRAMAMINE ® ALL DAY LESS DROWSY*
*This product is not manufactured or distributed by the owner of registered trademark of DRAMAMINE ®
MADE IN USA
Manufactured by:
APNAR PHARMA LLP
East Windsor, NJ 08520
Rev.:10/2022
Package Label.Principal Display Panel
NDC 24689-146-01
Meclizine HCL 25 mg
Antiemetic
100 Tablets
* Please review the disclaimer below.