FEXOFENADINE HYDROCHLORIDE - fexofenadine hydrochloride oral suspension 
Aurohealth LLC

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Fexofenadine Hydrochloride Oral Suspension 30 mg/5 mL

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:

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

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

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

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

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 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)


FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride oral suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-426
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Fexofenadine Hydrochloride (UNII: 2S068B75ZU) (Fexofenadine - UNII:E6582LOH6V) Fexofenadine Hydrochloride30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-426-241 in 1 CARTON05/23/2023
1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2NDC:58602-426-201 in 1 CARTON05/23/2023
2240 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21346605/23/2023
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650918514ANALYSIS(58602-426) , MANUFACTURE(58602-426)

Revised: 6/2023
Document Id: a75ff860-f7e0-4e19-846b-fbe33e0e1dfd
Set id: e8e35d7a-a86b-4d37-979b-f454978f070b
Version: 2
Effective Time: 20230606
 
Aurohealth LLC