FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride oral suspension

Fexofenadine Hydrochloride by

Drug Labeling and Warnings

Fexofenadine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC, APL HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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: phosphorus 15 mg and sodium18 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)

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride oral suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-426
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Fexofenadine Hydrochloride (UNII: 2S068B75ZU) (Fexofenadine - UNII:E6582LOH6V)	Fexofenadine Hydrochloride	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
STRAWBERRY (UNII: 4J2TY8Y81V)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-426-24	1 in 1 CARTON	05/23/2023
1		120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2	NDC: 58602-426-20	1 in 1 CARTON	05/23/2023
2		240 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213466	05/23/2023

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		650918514	ANALYSIS(58602-426) , MANUFACTURE(58602-426)