FDA Label for Childrens Allergy
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 5 ML)
- PURPOSE
- USES
- DO NOT USE
- 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.
- DIRECTION
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Childrens Allergy Product Label
The following document was submitted to the FDA by the labeler of this product Equate (wal-mart Stores, Inc.) (see Also Wal-mart 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)
Fexofenadine HCL USP 30 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.
Ask A Doctor Before Use If You Have
kidney disease. Your doctor should determine if you need a different dose.
When Using This Product
- do not take more than directed
- do not take at the same time as aluminum or magnesium antacids
- do not take with fruit juices (see Directions)
Stop Use And Ask A Doctor If
an allergic reaction to this product occurs. Seek medical help right away.
If Pregnant Or Breast-Feeding,
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 (1-800-222-1222) right away.
Direction
- shake well before using
- use only with enclosed dosing cup
adults and children 12 years of age and over | take 10 mL every 12 hours: do not take more than 20 mL in 24 hours |
children2 to under 12 years of age | take 5 mL every 12 hours; do not take more than 10 mL in 24 hours |
children under2 years of age | ask a doctor |
adults 65 years of age and older | ask a doctor |
consumers with kidney disease | ask a doctor |
Note: mL = mililiters
Other Information
- each 5 mL contains: sodium 18 mL
- store between 20° and 25°C (68° and 77°F)
- before using any medication, read all label directions. Keep carton, it contain important information.
Inactive Ingredients
artificial raspberry flavor, butylparaben, edetate disodium, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic, sodium phosphate, monobasic, sucrose, titanium dioxide, xanthan gum, xylitol
Questions Or Comments?
Principal Display Panel
*Compare to the active ingredient in Children's Allegra® Allergy
Children's Allergy
Fexofenadine HCL
Oral Suspension 30 mg/5mL
Antihistamine
Indoor/Outdoor allergy relief
- sneezing
- runny nose
- itchy, watery eyes
- itchy nose or throat
12 Hour Relief
Ages 2 years and older
Non-drowsy
Dye-free
Alcohol-free
BERRY FLAVOR
FL OZ (mL)
*This product is not manufactured or distributed by Chattem Inc., distributor of Children's Allegra® Allergy 12
TAMPER EVIDENT: DO NOT USE IF CARTON, UNPRINTED FOIL INNER SEAL, OR NECKBAND PRINTED WITH "SEALED FOR YOUR PROTECTION" IS OPENED TORN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Distributed By Wal-Mart Inc
Bentonville AR 72716
Product Label
EQUATE Children's Allergy
* Please review the disclaimer below.