Label: CHILDRENS ALLERGY- fexofenadine hcl suspension

  • NDC Code(s): 49035-208-04
  • Packager: EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 11, 2023

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  • Active ingredient (in each 5 mL)

    Fexofenadine HCL USP 30 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • runny nose
    • sneezing
    • itchy, watery eyes
    • 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.

    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.

  • Direction

    • 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
    children2 to under 12 years of agetake 5 mL every 12 hours; do not take more than 10 mL in 24 hours
    children under2 years of ageask a doctor
    adults 65 years of age and olderask a doctor
    consumers with kidney diseaseask a doctor


    Note: mL = mililiters

  • Other information

    • each 5 mL contains: sodium 18 mL
    • store between 20º and 25ºC (68º and 77ºF)
    • before using any medication, read all label directions. Keep carton, it contain important information.
  • Inactive ingredients

    artificial raspberry flavor, butylparaben, edetate disodium, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic, sodium phosphate, monobasic, sucrose, titanium dioxide, xanthan gum, xylitol

  • Questions or comments?

    1-888-287-1915

  • Principal Display Panel

    Compare to Children's Allegra® Allergy active ingredient*

    Childrens

    ALLERGY RELIEF

    Fexofenadine HCL

    Oral Suspension 30 mg/5mL

    Antihistamine

    Nin-Drowsy

    Alcohol-Free Dye-Free

    AGES 2 YEARS AND OLDER

    12 HOUR

    • sneezing
    • runny nose
    • itchy, watery eyes
    • itchy nose or throat

    Indoor / Outdoor Allergy Relief

    Berry Flavor

    FL OZ (mL)

    Dosing Cup Enclosed

    Use only with enclosed dosing cup.Wash and let air dry after each use.

    *This product is not manufactured or distributed by Chattem Inc., distributor of  Children's Allegra® Allergy.

    TAMPER EVIDENT: DO NOT USE IF CARTON, UNPRINTED FOIL INNER SEAL, OR NECKBAND PRINTED WITH "SEALED FOR YOUR PROTECTION" IS OPENED TORN OR MISSING

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    Distributed By Wal-Mart Inc

    Bentonville AR 72716


  • Product Label

    Fexofenadine HCl, USP 30 mg

    EQUATE Children's Allergy Relief Berry Flavor

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY 
    fexofenadine hcl suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-208
    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
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-208-041 in 1 CARTON07/01/2020
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20333007/01/2020
    Labeler - EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) (051957769)
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