Label: CHILDREN ALLERGY- fexofenadine hcl suspension

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 25, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • 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 toll free: 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to Children's Allegra® Allergy active ingredient**

    Children's Allergy

    Fexofenadine HCl Oral Suspension 30 mg/ 5 mL

    Antihistamine

    Allergy Relief

    Alcohol Free

    Dye Free

    Non-Drowsy

    For Ages 2 years and Older

    Indoor/Outdoor Relief of:

    • 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

    FL OZ (mL)

    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 "SEAL FOR YOUR SAFETY" IS TORN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION .

    MADE WITH PRIDE AND CARE FOR H-E-B®, SAN ANTONIO, TX 78204

  • Product Label

    Fexofenadine HCl, USP 30 mg

    H-E-B Children's Allergy Berry Flavor

  • INGREDIENTS AND APPEARANCE
    CHILDREN ALLERGY 
    fexofenadine hcl suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-654
    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:37808-654-041 in 1 BOX10/31/2023
    1118 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 - H E B (007924756)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!