Active Ingredient (In Each 5 Ml)
Fexofenadine HCL USP 30 mg
Childrens Allergy Suspension
FDA Label NDC 37808-623
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H E B for the product Childrens Allergy (NDC 37808-623). 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 |
| children 2 to under 12 years of age | take 5 mL every 12 hours; do not take more than 10 mL in 24 hours |
| children under 2 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° to 25°C (68° to 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?
Call toll free: 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to Children's Allegra® Allergy active ingredient**
Childrens
ALLERGY
Fexofenadine HCl
Oral Suspension 30 mg/5mL
Antihistamine
Allergy Relief
Alcohol Free
Dye Free
Non-Drowsy
For Ages 2 years and Over
12 HOUR
Indoor/Outdoor Relief of:
- Sneezing
- Runny nose
- Itchy, watery eyesIitchy nose or throat
Berry Flavor
FL OZ (mL)
Use only with enclosed dosing cup. Wash and let air dry after each use.
*This product is not manufactured or distributed by Chattem Inc., distributor of Children's Allegra® Allergy.
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
MADE WITH PRIDE AND CARE FOR H-E-B®
SAN ANTONIO, TX 78204
Product Label
H-E-B Children's Allergy
* Please review the disclaimer below.
