Otc - Active Ingredient
Active ingredient (in each tablet)
Meclizine HCL 25 mg
Meclizine Hydrochloride Tablet
FDA Label NDC 24689-146
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Apnar Pharma Lp for the product Meclizine Hydrochloride (NDC 24689-146). 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, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
