Label: CHILDREN ALLERGY- fexofenadine hcl suspension

  • NDC Code(s): 0363-2600-04, 0363-2600-08
  • Packager: Walgreens
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 23, 2024

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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 overtake 10 mL every 12 hours; do not take more than 20 mL in 24 hours
    children 2 to under 12 years of agetake 5 mL every 12 hours; do not take more than 10 mL in 24 hours
    children under 2 years of ageask a doctor
    adults 65 years of age and olderask a doctor
    consumers with kidney diseaseask a doctor

    Note: mL = milliliters

  • Other information

    • each 5 mL contains: sodium 17 mg
    • store between 20º to 25ºC (68º and 77ºF)
  • 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?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to the active ingredient in Children's Allegra® Allergy††

    NON-DROWSY

    2 YEARS & OLDER

    Children's Allergy Relief

    FEXOFENADINE HCl ORAL SUSPENSION

    30 mg/ 5 mL/ ANTIHISTAMINE

    Dye Free  Non-Drowsy

    12-Hour Relief  Alcohol Free

    • Indoor/outdoor allergy relief of sneezing, runny nose, itchy nose or throat & itchy, watery eyes

    AGES 2 YEARS & OLDER

    Berry flavor

    FL OZ (mL)

    LIQUID ORAL SUSPENSION

    USE ONLY WITH ENCLOSED DOSING CUP. WASH AND LET AIR DRY AFTER EACH USE

    *This product is not manufactured or distributed by Sanofi Consumer Healthcare NA, distributor of Children's Allegra® Allergy.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF SEAL ON BOTTLE PRINTED WITH "SEALED FOR SAFETY" ISTORN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION .

    DISTRIBUTED BY: WALGREEN CO.

    DEERFIELD, IL 60015

  • Product Label

    Fexofenadine HCl, USP 30 mg

    WALGREENS Children's Allergy Relief Berry Flavor

  • INGREDIENTS AND APPEARANCE
    CHILDREN ALLERGY 
    fexofenadine hcl suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-2600
    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:0363-2600-041 in 1 BOX10/31/2023
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0363-2600-081 in 1 BOX10/31/2023
    2237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20333010/31/2023
    Labeler - Walgreens (008965063)
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