FDA Label for Childrens Xyzal Allergy
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 5 ML)
- PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- 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
Childrens Xyzal Allergy Product Label
The following document was submitted to the FDA by the labeler of this product Chattem, 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)
Levocetirizine dihydrochloride 2.5 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
Warnings
Do not use
- if you have kidney disease
- if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine
Ask A Doctor Before Use If You Have
- ever had trouble urinating or emptying your bladder
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
- you have trouble urinating or emptying your bladder
- 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
adults 65 years of age and older | ■ ask a doctor |
adults and children 12-64 years of age | ■ take 5 mL or 10 mL once daily in the evening depending upon severity of symptoms ■ do not take more than 10 mL in 24 hours |
children 6-11 years of age | ■ take 5 mL once daily in the evening ■ do not take more than 5 mL in 24 hours |
children 2-5 years of age | ■ take 2.5 mL once daily in the evening ■ do not take more than 2.5 mL in 24 hours |
children under 2 years of age | ■ do not use |
consumers with kidney disease | ■ do not use |
Note: mL = milliliters |
Other Information
- each 5 mL contains: sodium 3 mg
- store between 20° and 25°C (68° and 77°F)
- safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
Inactive Ingredients
flavor, glacial acetic acid, glycerin, maltitol solution, methylparaben, propylparaben, purified water, saccharin sodium, sodium acetate trihydrate
Questions Or Comments?
call 1-800-633-1610
Principal Display Panel
NDC 41167-3530-1
Children’s
XYZAL
Allergy 24HR
5 fl. oz.
(148 mL)
Tutti Frutti Flavor
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