FDA Label for Cetirizine Hydroloride Allergy
View Indications, Usage & Precautions
Cetirizine Hydroloride Allergy Product Label
The following document was submitted to the FDA by the labeler of this product Caraco Pharmaceutical Laboratories, Ltd. 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.
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
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.
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 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 a Poison Control Center right away toll-free number 1-800-222-1222.
Directions
- use only with enclosed dosing cup
adults and children 6 years and over | 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. |
adults 65 years and over | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 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) or store refrigerated, 2 to 8°C (36 to 46°F)
Inactive Ingredients
Artificial grape flavor, glacial acetic acid, glycerin, methylparaben, purified water, propylene glycol, propylparaben, sodium acetate, and sucrose
Questions Or Comments?
call toll-free 1-800-818-4555 weekdays
Dosing Cup Included
Dosing cup should be washed and left to air dry after each use.
Do not use if carton is opened, or if seal on bottle is broken or missing.
Dist. by: Caraco Pharmaceutical Laboratories, Ltd.
Detroit, Michigan 48202
Mfg. by: SUN Pharmaceutical Industries, Inc.
Bryan, Ohio 43506
6028L01 Iss: 09/11
Principal Display Panel
NDC 57664-263-31
2 years & older
Children’s
Cetirizine
Hydrochloride
1mg / mL Oral Solution, USP
antihistamine
ALLERGY
Indoor and Outdoor Allergies
24 Hour Relief of
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
Dosing Cup Included
Do not use if carton is opened, or if seal on bottle is broken or missing.
2 years and older
Grape Syrup
4 fl. oz. (120 mL)
* Please review the disclaimer below.