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 Rebel Distributors Corp. 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
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
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 reactions 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.
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
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
- if breast-feeding: not recommended
- if pregnant: ask a health professional before 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:
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 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 to 25 C (68 to 77 F)
Inactive Ingredients
Corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate, povidone and titanium dioxide.
Questions? 1-800-525-8747
Manufactured in India by Sandoz Private Ltd.,
for Sandoz Inc., Princeton, NJ 08540
Rev.02/2008
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
Principal Display Panel
NDC 21695-709-10 Bottle of 10
NDC 21695-709-14 Bottle of 14
NDC 21695-709-20 Bottle of 20
NDC 21695-709-30 Bottle of 30
Cetirizine HCl Tablets
10 mg
antihistamine
Do not use if individual blister unit is open or torn
ALLERGY
Indoor & Outdoor Allergies
24 hour Relief of
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
* Please review the disclaimer below.