FDA Label for Meclizine Hcl
View Indications, Usage & Precautions
Meclizine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Aphena Pharma Solutions - Tennessee, Llc. 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.
Active Ingredient
Meclizine Hydrochloride 25 mg
Purpose
Antiemetic
Uses
For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness. For other uses consult your doctor
Warnings
Ask a doctor before use if you have
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an elarged prostate gland
- you may get drowsy
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increse drowsiness
- be careful when driving a moor vehicle or operating machinery
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
Directions
take dose one hour before travel starts
tablets can be chewed or swallowed whole with water
adults & children 12 years and over:
- take 1-2 tablets once daily
- ask a doctor
children under 12 years:
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Other Information
Phenylketonurics:
each tablet contains:
phenylalanine 0.28 mg
store at room temparature 15 - 30 °C
Questions Or Comments
Call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients
Aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red 40 (al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor
Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
| Count | 25 mg |
| 30 | 71610-0528-30 |
| 90 | 71610-0528-60 |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20210415JH
Principal Display Panel - 25 Mg
NDC 71610-528 - Meclizine HCl 25 mg Chewable Tablets
* Please review the disclaimer below.