Active Ingredients (In Each Tablet)
Meclizine HCl 25 mg
Meclizine Hcl
FDA Label NDC 13811-648
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trigen Laboratories, Inc. for the product Meclizine Hcl (NDC 13811-648). 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 ingredients (in each tablet), purpose, uses:, warning: ask a doctor before use if you have, keep out of reach of children, when using product, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiemetic
Uses:
prevents and treats nausea, vomiting, or dizziness due to motion sickness.• For other uses, consult your doctor.
Warning: Ask A Doctor Before Use If You Have
• Glaucoma • A breathing problem such as emphysema or chronic bronchitis • Trouble urinating due to an enlarged prostate gland.
Keep Out Of Reach Of Children
When Using Product
• You may get drowsy • Avoid alcoholic drinks • Alcohol, sedatives and tranquilizers may increase drowsiness • Be careful when driving a motor vehicle or operating machinery
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
• Take dose one hour before travel starts • Tablets can be chewed or swallowed whole with water • Adults & children 12 years and over: 1-2 tablets once daily • Children under 12 years: ask a doctor
Other Information
• each tablet contains: calcium 51 mg
• Store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients
Microcrystalline cellulose, magnesium stearate, lactose, Raspberry flavor, FD&C Red #40 lake, starch, sodium saccharin, and dextrates hydrated.
Principal Display Panel - 25 Mg Chewable Tablet Label
NDC 13811-648-10
Meclizine HCl
25 mg
100 CHEWABLE TABLETS
TRIGEN
LABORATORIES
Principal Display Panel (25 mg)
* Please review the disclaimer below.
