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 Lake Erie Medical Dba Quality Care Products 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 Ingredients
Active Ingredients (in each tablet) Purpose
Cetirizine HCl 10 mg..............................................................................................Antihistimine
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
Warnings
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.
Otc - Ask Doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
When Using This Product
- drowsines may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinary.
Otc - Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If Pregnant Or Breast-Feeding:
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact Poison Control Center right away.
Directions
| Adults and children 6 years and over | 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 sever 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° to 25°C (68° to 77°F)
Inactive Ingredients
Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.
Questions?
Call 1-866-562-4597
Other
Manufactured for PACK Pharmaceuticals, LLC
Buffalo Grove, IL 60089, USA
Manufactured by Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),
Mumbai 400 030, India
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