Label: CHILDRENS ALLERGY RELIEF- fexofenadine hcl tablet

  • NDC Code(s): 63548-0662-5
  • Packager: PLD Acquisitions LLC DBA Avéma Pharma Solutions
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 31, 2019

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

  • Active ingredient (in each tablet)

    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 right away (1-800-222-1222).

  • Directions

    adults and children 12 years of age and overtake two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours 
    children 6 to under 12 years of age  take one tablet with water every 12 hours; do not take more than 2 tablets in 24 hours 
    children under 6 years of age  do not use
    adults 65 years of age and older ask a doctor 
    consumers with kidney disease  ask a doctor

  • Other information

    • Tamper Evident: do not use if printed safety seal under cap is broken or missing
    • store between 20º and 25ºC (68º and 77ºF)
    • protect from excessive moisture
  • Inactive ingredients

    colloidal silicon dioxide, hypromellose, light liquid paraffin magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide

  • Questions or comments?


  • Principal Display Panel

    *Compare to the active ingredient in Children's Allegra® Allergy 12 Hour

    Children's Allergy Relief

    Fexofenadine HCL USP 30 mg

    Antihistamine

    24 Hour Relief of:

    • sneezing
    • runny nose
    • itchy, watery eyes
    • itchy nose or throat

    Indoor and outdoor allergy relief

    Non-drowsy

    Tablets

    *This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 12 hour.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.


  • Product Label

    Fexofenadine HCL USP 30 mg

    CHILDRENS ALLERGY RELIEF

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF 
    fexofenadine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0662
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize6mm
    FlavorImprint Code J;42
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63548-0662-5500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20409710/01/2019
    Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)