Active Ingredient (In Each 5 Ml)
Fexofenadine HCl, USP 30 mg
Childrens Allergy Suspension
FDA Label NDC 55319-923
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar (family Wellness) for the product Childrens Allergy (NDC 55319-923). 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 = milliliters
Other Information
- each 5 mL contains: sodium 18 mg
- store between 20° to 25°C (68° and 77°F)
- before using any medication, read all label directions. Keep carton, it contains 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 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
*Compare to the active ingredient in Children's Allegra® Allergy††
Children's Allergy
Fexofenadine HCl
Oral Suspension 30 mg/5 mL
Antihistamine
Indoor/Outdoor allergy
- 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)
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.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
TAMPER EVIDENT: DO NOT USE IF CARTON, UNPRINTED FOIL INNER SEAL OR NECKBAND PRINTED WITH "SEAL FOR YOUR PROTECTION" IS OPENED, TORN OR MISSING
DISTRIBUTED BY
MIDWOOD BRANDS, LLC
500 VOLVO PARKWAY,
CHESAPEAKE, VA 23320
Product Label
FAMILY WELLNESS Children's Allergy Berry Flavor
* Please review the disclaimer below.
