Label: ALLERGY RELIEF- fexofenadine hcl tablet, coated

  • NDC Code(s): 63548-0663-5
  • Packager: PLD Acquisitions LLC DBA Avéma Pharma Solutions
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 16, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient (in each tablet)

    Fexofenadine HCl USP 60 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 one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
    children under 12 years of agedo not use
    adults 65 years of age and olderask a doctor
    consumers with kidney diseaseask 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, and yellow iron oxide

  • Questions or comments?

  • Principal Display Panel

    *Compare to the active ingredient in Allegra® Allergy 12 hour

    Allergy Relief

    Fexofenadine HCL USP 180 mg

     Antihistamine

    12 HOUR RELIEF OF:

    • Sneezing
    • Runny Nose
    • Itchy, Water Eyes
    • Itchy Throat or Nose

    Caplets**

    (**Capsule-shaped 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 MISSING.

  • Product Label

    Fexofenadine HCL USP 60 mg

    Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    fexofenadine hcl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0663
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    TALC (UNII: 7SEV7J4R1U)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize12mm
    FlavorImprint Code J;43
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63548-0663-5500 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)