Label: CHILDRENS ALLEGRA ALLERGY- fexofenadine hydrochloride suspension

  • NDC Code(s): 41167-4244-1, 41167-4244-4, 41167-4244-7, 41167-4246-2, view more
    41167-4246-4
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 16, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    (in each 5 mL)

    Fexofenadine HCI 30 mg

  • Purpose

    Antihistamine

  • Uses

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

    • runny nose
    • sneezing
    • itchy, water 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 right away.

  • Directions

    • 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: each 5 mL contains: potassium 5 mg and sodium 19 mg
    • safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
    • store between 20° and 25°C (68° and 77°F)
    • color change from white to beige is expected over time. This does not impact product effectiveness and safety.
  • Inactive ingredients

    edetate disodium, flavor, poloxamer 407, potassium sorbate, propylene glycol, purified water, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucrose, titanium dioxide, xanthan gum, xylitol

  • Questions or comments?

    call toll-free 1-800-844-2798 

  • PRINCIPAL DISPLAY PANEL

    NDC 41167-4244-4
    Children’s
    Allegra®
    ALLERGY
    fexofenadine HCI
    oral suspension
    12 HR
    30 mg/5 ml antihistamine

    PRINCIPAL DISPLAY PANEL NDC 41167-4244-4 Children’s Allegra® ALLERGY fexofenadine HCI oral suspension 12 HR 30 mg/5 ml antihistamine

  • PRINCIPAL DISPLAY PANEL

    NDC 41167-4246-4
    Children’s
    Allegra®
    ALLERGY
    fexofenadine HCI
    oral suspension
    12 HR
    30 mg/5 ml antihistamine

    PRINCIPAL DISPLAY PANEL NDC 41167-4246-4 Children’s Allegra® ALLERGY fexofenadine HCI oral suspension 12 HR 30 mg/5 ml antihistamine

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLEGRA ALLERGY 
    fexofenadine hydrochloride suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-4244
    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)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-4244-41 in 1 CARTON03/03/2011
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:41167-4244-11 in 1 CARTON03/03/2011
    2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:41167-4244-73 in 1 CELLO PACK03/03/2011
    3120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20137303/03/2011
    CHILDRENS ALLEGRA ALLERGY 
    fexofenadine hydrochloride suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-4246
    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)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-4246-41 in 1 CARTON03/01/2023
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:41167-4246-21 in 1 CARTON03/01/2023
    2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20137303/03/2011
    Labeler - Chattem, Inc. (003336013)
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