FDA Label for Childrens Cetirizine Hydrochloride
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 5 ML)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING:
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Childrens Cetirizine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Preferred Pharmaceuticals Inc.. 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)
Cetirizine HCl 5 mg
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
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.
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
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 a Poison Control Center right away. (1-800-222-1222)
Directions
• use only with enclosed dosing cup• find right dose on chart below• mL = milliliter
adults and children 6 years and over | 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. |
adults 65 years and over | 5 mL once daily; do not take more than 5 mL in 24 hours. |
children 2 to under 6 years of age | 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 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)• do not use if carton is opened, or if printed neckband is broken or missing• see bottom panel for lot number and expiration date
Inactive Ingredients
anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose
Questions Or Comments?
1-800-616-2471
Package/Label Principal Display Panel
COMPARE TO the active ingredient of CHILDREN’S ZYRTEC®
Children’s Cetirizine Hydrochloride Oral Solution 1 mg/mL
Antihistamine
ALLERGY
INDOOR & OUTDOOR ALLERGIES
24 HOUR RELIEF OF:
Sneezing / Runny Nose
Itchy, Watery Eyes / Itchy Throat or Nose
4 FL OZ
24 Hour
(118 mL)
2yrs & older
Dosing Cup Included
Dye-Free
Sugar-Free
Grape Flavored Syrup
Relabeled By: Preferred Pharmaceuticals Inc.
* Please review the disclaimer below.