Active Ingredient (In Each Chewable Tablet)
Meclizine HCl 25 mg
Meclizine Hydrochloride
FDA Label NDC 80136-779
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Northeast Pharma for the product Meclizine Hydrochloride (NDC 80136-779). 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 chewable tablet), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, 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
Do Not Use
for 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
- alcohol, sedatives, and tranquilizers may increase drowsiness
- drowsiness may occur
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not exceed recommended dose
- dosage should be taken one hour before travel starts
- chew or crush tablets completely before swallowing;do not swallow tablets whole
- adults and children 12 years and over: take 1 to 2 tablets once daily or as directed by a doctor
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, FD&C red #40 aluminum lake, flavor, lactose anhydrous, magnesium stearate, saccharin sodium, silicon dioxide
Questions Or Comments?
1-800-540-3765
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