Active Ingredient (In Each 5 Ml)
Fexofenadine HCL USP 30 mg
Childrens Allergy Suspension
FDA Label NDC 49035-208
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc) for the product Childrens Allergy (NDC 49035-208). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 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,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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?
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*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.
