FDA Label for Childrens Allergy
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 5 ML TEASPOONFUL)
- 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?
- PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL
Childrens Allergy Product Label
The following document was submitted to the FDA by the labeler of this product Quality Choice (chain Drug Marketing Association). 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:
- sneezing
- runny nose
- 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
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- 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. (1800-222-1222)
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 | 1/2 teaspoonful (2.5 mL) once dailly. 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°-25°C (68°-77°F)
Inactive Ingredients
glacial acetic acid, grape flavr, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose
Questions Or Comments?
Call 1-248-449-9300 Monday-Friday 9AM-5PM EST
Principal Display Panel
*Compare to the active ingredient in Children's Zyrtec®
Children's Allergy
Indoor & Outdoor Allergies
Cetirizine Oral Solution
1mg/mL | Antihistamine
24-Hour relief of:
Sneezing
Runny nose
Itchy, watery eyes
Itchy throat or nose
For Ages 2 Years & Older
Dye-free
Grape Flavor
Dosing Cup Included
FL OZ (mL)
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Zyrtec®
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Dosing cup should be washed and left to air dry after each use
Distributed by C.D.M.A Inc.
43157 W. Nine Mile
Novi, MI 48376-0995
Package Label
QUALTY CHOICE Children's Allergy Grape Liquid
* Please review the disclaimer below.