Label: FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride oral suspension

  • NDC Code(s): 58602-426-20, 58602-426-24
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 6, 2023

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  • 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 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)


  • INGREDIENTS AND APPEARANCE
    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)
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