FDA Label for Cetirizine Hydrochloride
View Indications, Usage & Precautions
Cetirizine Hydrochloride 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 (In Each Tablet)
Cetirizine HCl 10 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
When Using This Product
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Directions
| adults and children 6 years and over | Take one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms |
| adults 65 years and over | ask a doctor |
| children under 6 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Other Information
- store between 20° and 25°C (68° - 77°F)
Inactive Ingredients
Lactose monohydrate, microcrystalline cellulose, starch (corn), magnesium stearate, hypromellose, polydextrose, polyethylene glycol and titanium dioxide.
Questions Or Comments?
1-800-645-2158
*This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of Zyrtec®. Zyrtec® is a registered trademark of UCB Pharma, S.A.
| Distributed by: |
| Rugby Laboratories |
| 31778 Enterprise Drive |
| Livonia, MI 48150 |
| Re-order No. 255553 |
| R-126 |
| Rev. 06/14 |
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 | 10 mg |
| 90 | 71610-093-60 |
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
20180717JH
Principal Display Panel - 10 Mg
NDC 71610-093 - Cetirizine HCl 10 mg - Rx Only
* Please review the disclaimer below.
