FDA Label for Childrens Cetirizine Hydrochloride
View Indications, Usage & Precautions
Childrens Cetirizine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium, Llc (premier Value). 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 5 Ml Teaspoonful)
Cetirizine HCl 5 mg
Purpose
Antihistamine
Uses
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
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
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 older | 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 | 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 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)
Inactive Ingredients
artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucrose
Questions?
Call 1-866-923-4914
Principal Display Panel - 120 Ml Bottle Carton
NDC 68016-023-43
Ages
two years
and older
Compare to
the active ingredient
in Children's Zyrtec®*
Premier
Value®
CHILDREN'S
CETIRIZINE
HYDROCHLORIDE
ORAL SOLUTION
1 mg/1 mL
Antihistamine
Grape Flavored Syrup
24 hour Allergy Relief of:
Sneezing; Runny Nose;
Itchy,Watery Eyes;
Itchy Throat or Nose
Indoor & Outdoor Allergies
Dosing Cup
Included
PV
PREMIER VALUE GUARANTEE
4 FL OZ (120 mL)
* Please review the disclaimer below.