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
Cetirizine HCl 10 mg..............................................................................................Antihistimine
Active Ingredients (in each tablet) Purpose
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
if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
Do Not Use
Otc - Ask Doctor
liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor before use if you have
Otc - Ask Doctor/Pharmacist
taking tranquilizers or sedatives. Ask a doctor or pharmacist before use if you are
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
if an allergic reaction to this product occurs. Seek medical help right away. Stop use and ask a doctor
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
|
Inactive Ingredients
Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.
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
* Please review the disclaimer below.
