Label: CHILDRENS FEXOFENADINE HYDROCHLORIDE HIVES- fexofenadine hydrochloride suspension

  • NDC Code(s): 51672-2121-1, 51672-2121-4, 51672-2121-8
  • 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 November 29, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    Fexofenadine HCI 30 mg

  • Purpose

    Antihistamine

  • Uses

    reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

  • Warnings

    Severe Allergy Warning

    Get emergency help immediately if you have hives along with any of the following symptoms:

    • swelling of tongue
    • trouble swallowing
    • swelling in or around mouth
    • trouble speaking
    • wheezing or problems breathing
    • drooling
    • dizziness or loss of consciousness

    These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

    Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

    Do not use

    • to prevent hives from any known cause such as:
      • foods
      • insect stings
      • medicines
      • latex or rubber gloves
      because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
    • 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.
    • hives that are an unusual color, look bruised or blistered
    • hives that do not itch

    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.
    • symptoms do not improve after 3 days of treatment
    • the hives have lasted more than 6 weeks

    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 6 to under 12 years of agetake 5 mL every 12 hours; do not take more than 10 mL in 24 hours
    children under 6 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 9 mg
    • safety sealed: do not use if carton is opened or if foil inner seal on bottle is torn or missing
    • store between 20° and 25°C (68° and 77°F)
  • Inactive ingredients

    artificial raspberry flavor, butylparaben, edetate disodium, maltitol solution, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucralose, 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

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

    NDC 51672-2121-8

    Children's
    Fexofenadine HCI
    Oral Suspension,
    30 mg/ 5 mL

    Antihistamine
    HIVES

    NON-DROWSY

    Berry Flavor

    Ages 6 Years
    & Older

    12
    Hour
    RELIEF OF
    ITCHING DUE
    TO HIVES

    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   HIVES
    fexofenadine hydrochloride suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2121
    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)  
    maltitol (UNII: D65DG142WK)  
    poloxamer 407 (UNII: TUF2IVW3M2)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    sodium phosphate, dibasic, heptahydrate (UNII: 70WT22SF4B)  
    sodium phosphate, monobasic, monohydrate (UNII: 593YOG76RN)  
    sucralose (UNII: 96K6UQ3ZD4)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51672-2121-41 in 1 CARTON11/09/2017
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:51672-2121-81 in 1 CARTON11/09/2017
    2120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:51672-2121-11 in 1 CARTON11/09/2017
    3240 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20812311/09/2017
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
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