FDA Label for Childrens Fexofenadine Hydrochloride Allergy
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT ( IN EACH 5 ML)
- PURPOSE
- USES
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- WHEN USING THIS PRODUCT
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 120 ML BOTTLE CARTON
Childrens Fexofenadine Hydrochloride Allergy Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens Company. 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.
Other
Drug Facts
DISTRIBUTED BY: WALGREEN CO.
DEERFIELD, IL 60015
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.
