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Drug Facts
DISTRIBUTED BY: WALGREEN CO.
DEERFIELD, IL 60015
Childrens Fexofenadine Hydrochloride Suspension
FDA Label NDC 0363-2141
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens Company for the product Childrens Fexofenadine Hydrochloride (NDC 0363-2141). 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 other, active ingredient ( in each 5 ml), purpose, uses, otc - do not use, otc - ask doctor, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient ( In Each 5 Ml)
Fexofenadine HCl 30 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
Otc - Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Otc - Ask Doctor
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)
Otc - Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- shake well before using
- use only with enclosed dosing cup
| Note: mL = milliliters | |
| 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 |
Other Information
- each 5 mL contains: sodium 14 mg
- safety sealed: do not use if carton is opened or if foil inner seal on bottle is torn or missing
- store between 20° and 25°C (68° and 77°F)
Inactive Ingredients
artificial raspberry flavor, edetate disodium, maltitol solution, poloxamer 407, potassium sorbate, propylene glycol, purified water, sodium benzoate, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucralose powder, titanium dioxide and xanthan gum
Questions?
Call 1-866-923-4914
Principal Display Panel - 120 Ml Bottle Carton
NDC 0363-2141-08
Children's
Allergy Relief
Fexofenadine HCl
Oral Suspension,
30 mg/ 5 mL
4 FL OZ
(120 mL)
* Please review the disclaimer below.
