FDA Label for Childrens Allergy Relief
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH 5 ML)
- PURPOSE
- USES
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 120 ML BOTTLE CARTON
Childrens Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product Preferred Plus (kinray). 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.
Other
Drug Facts
Distributed by:
Kinray LLC.
152-35 10th Ave.
Whitestone, NY 11357
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
Otc - Do Not Use
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.
Otc - Ask Doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Otc - Ask Doctor/Pharmacist
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
Otc - Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding:
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
- do not use if carton is opened or if imprinted safety seal is broken or missing
- see bottom panel for lot number and expiration date
- 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), sucralose
Questions?
Call 1-866-923-4914
Principal Display Panel - 120 Ml Bottle Carton
Compare to the
active ingredient
in Children's Zyrtec®*
NDC 61715-157-04
Preferred
plus Pharmacy®
Children's
Allergy Relief
(Cetirizine Hydrochloride
Oral Solution)
1 mg/mL Antihistamine
Indoor & Outdoor Allergies
SUGAR FREE
24
Hour
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
2 Yrs. & older
Grape Flavor
4 FL OZ
(120 mL)
Dosing Cup Included
* Please review the disclaimer below.