CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated
Aphena Pharma Solutions - Tennessee, LLC
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temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
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 |
Lactose monohydrate, microcrystalline cellulose, starch (corn), magnesium stearate, hypromellose, polydextrose, polyethylene glycol and titanium dioxide.
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 |
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
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, film coated |
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Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Aphena Pharma Solutions - Tennessee, LLC | 128385585 | REPACK(71610-093) |