Label: CHILDRENS FEXOFENADINE HYDROCHLORIDE ALLERGY- fexofenadine hydrochloride suspension

  • NDC Code(s): 51672-2141-1, 51672-2141-8
  • Packager: Taro Pharmaceuticals U.S.A., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 25, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    Fexofenadine HCl 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.

    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 right away.

  • Directions

    • shake well before using
    • use only with enclosed dosing cup
    Note: mL = milliliters
    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
  • Other information

    • each 5 mL contains: sodium 14 mg
    • safety sealed: do not use if carton is opened, or if imprinted safety seal is broken or missing.
    • store between 20º and 25ºC (68º and 77ºF)
  • Inactive ingredients

    artificial raspberry flavor, edetate disodium, maltitol solution, poloxamer 407, potassium sorbate, propylene glycol, purified water, sodium benzoate, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucralose powder, titanium dioxide and xanthan gum

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Taro Pharmaceuticals U.S.A., Inc.
    Hawthorne, NY 10532

  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

    NDC 51672-2141-8

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

    Children's
    Allergy
    Fexofenadine HCl
    Oral Suspension,
    30 mg/ 5 mL
    Antihistamine

    NON-DROWSY

    12
    Hour

    Berry Flavor

    2
    Years
    & Older

    INDOOR/OUTDOOR
    ALLERGY RELIEF

    ✓
    Sneezing
    ✓
    Runny Nose
    ✓
    Itchy, Watery Eyes
    ✓
    Itchy Nose or Throat

    Dye free / Alcohol free / Sugar free

    LIQUID
    Oral Suspension

    4 fl. oz.
    (120 mL)

    PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CHILDRENS FEXOFENADINE HYDROCHLORIDE  ALLERGY
    fexofenadine hydrochloride suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2141
    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
    edetate disodium (UNII: 7FLD91C86K)  
    maltitol (UNII: D65DG142WK)  
    poloxamer 407 (UNII: TUF2IVW3M2)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    sucralose (UNII: 96K6UQ3ZD4)  
    potassium sorbate (UNII: 1VPU26JZZ4)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    xanthan gum (UNII: TTV12P4NEE)  
    sodium benzoate (UNII: OJ245FE5EU)  
    Product Characteristics
    ColorWHITE (white to off-white) Score    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51672-2141-81 in 1 CARTON01/24/2024
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:51672-2141-11 in 1 CARTON01/24/2024
    2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20812301/24/2024
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
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