Active Ingredient (In Each Tablet)
Meclizine HCl 25mg
Meclizine
FDA Label NDC 84289-387
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmamed Usa Inc for the product Meclizine (NDC 84289-387). 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 tablet), purpose, uses, warnings, do not take this product unless directed by a doctor if you have, if pregnant or breast-feeding,, 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 associated with motion sickness
Warnings
Do not use in children under 12 years of age unless directed by a doctor.
Do Not Take This Product Unless Directed By A Doctor If You Have
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- do not exceed the recommended dosage
- may cause drowsiness
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- use caution when driving a motor vehicle or operating machinery
Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.
When using this product
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 (1 800-222-1222)
Directions
- dosage should be taken one hour before travel starts
| Adults and children 12 years and over | take 1 or 2 tablets once daily or as directed by doctor |
Other Information
- Tamper Evident: do not use if the safety seal under cap is broken or missing
- store at 20°-25°C (68°-77°F)
Inactive Ingredients
Croscarmellose sodium, dextrose, FD&C Red#40, raspberry flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid
Questions Or Comments?
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Package Label Principal Display Panel
PHARMAMED
NDC 84289-387-01
Manufactured in the USA
Chewable, Once-A-Day Protection
MECLIZINE
Antiemetic
100 CHEWABLE TABLETS
Meclizine HCL 25mg
Raspberry Flavor
*Compare to the active ingredient in Bonine
* Please review the disclaimer below.
