Fexofenadine Hydrochloride FEXOFENADINE HYDROCHLORIDE ORAL AUROHEALTH LLC FDA Approved 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
FunFoxMeds bottle
Route
ORAL
Applications
ANDA213466

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredient (in each 5 mL) Fexofenadine Hydrochloride USP 30 mg
Inactive Ingredients
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.
Strengths
5 ml 30 mg
Quantities
240 ml 5 ml
Treats Conditions
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
Pill Appearance
Color: white

Identifiers & Packaging

Container Type BOTTLE
UPC
0358602426200
UNII
2S068B75ZU
Packaging

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 Container Label (240 mL Bottle); 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) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ Carton Container Label (240 mL Bottle)

Package Descriptions
  • 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 Container Label (240 mL Bottle)
  • 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) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ Carton Container Label (240 mL Bottle)

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Purpose

Purpose Antihistamine

When Using

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 & Ask a Doctor

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

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 (1-800-222-1222) right away.

Questions

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


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