FDA Label for Fexofenadine Hydrochloride
View Indications, Usage & Precautions
- DRUG FACTS
- PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL. OZ.(240 ML BOTTLE) CONTAINER LABEL
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL. OZ. (240 ML BOTTLE) CARTON CONTAINER LABEL
Fexofenadine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Aurohealth Llc. 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.
Drug Facts
Active ingredient (in each 5 mL)
Fexofenadine Hydrochloride USP 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
Warnings
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.
Otc - Pregnancy Or Breast Feeding
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.
Directions
- 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
- safety sealed: do not use if carton is opened or seal under cap opening is broken or missing
- store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
art strawberry flavor, dibasic sodium phosphate anhydrous, edetate disodium, ethylparaben, methylparaben, modified food starch (corn), monobasic sodium phosphate, poloxamer 407, propylene glycol, purified water, sucrose, titanium dioxide, triacetin, xanthan gum, xylitol.
Questions Or Comments?
call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: AP/DRUGS/04/2016
Package Label-Principal Display Panel - 8 Fl. Oz.(240 Ml Bottle) Container Label
AUROHEALTH
NDC 58602-426-20
Ages 2 Years & Older
NON-DROWSY
Children’s
Fexofenadine Hydrochloride
Oral Suspension
30 mg/5 mL
antihistamine
INDOOR / OUTDOOR ALLERGY RELIEF
Dosing Cup Included
Wash and let air dry
after each use
12 HR
Berry
FLAVOR
Alcohol & Dye FREE
8 fl. oz. (240 mL)
Package Label-Principal Display Panel - 8 Fl. Oz. (240 Ml Bottle) Carton Container Label
AUROHEALTH
NDC 58602-426-20
#Compare to the active Ingredient
in Children’s Allegra®Allergy
Ages 2 Years & Older
Children’s
Fexofenadine Hydrochloride
Oral Suspension
30 mg/5 mL
antihistamine 12 HR
NON-DROWSY
Liquid
INDOOR / OUTDOOR ALLERGY RELIEF
√ Sneezing
√ Runny Nose
√ Itchy, Watery Eyes
√ Itchy Nose or Throat
Use Only With
Enclosed Dosing Cup
Wash and let air dry after each use
Berry
FLAVOR
Alcohol & Dye FREE
8 fl. oz. (240 mL)
* Please review the disclaimer below.