Label: ALLERGY RELIEF- fexofenadine hcl tablet, coated

  • NDC Code(s): 81522-613-30
  • Packager: FSA Store Inc. (Caring Mills)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 24, 2024

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  • Active ingredient (in each tablet)

    Fexofenadine HCl USP, 180 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 (1-800-222-1222) right away.

  • Directions

    adults and children 12 years of age and over

    take one 180 mg tablet with water once a day;

    do not take more than 1 tablet in 24 hours
    children under 12 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

    • store between 20-25ºC (68-77ºF)
    • protect from excessive moisture
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), polyethylene glycol, titanium dioxide

  • Questions or comments?

    call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    *Compare to the active ingredient in Allegra® Allergy 24 Hour

    Allergy Relief

    Fexofenadine HCl Tablets, 180 mg

    Antihistamine

    24-Hour relief of

    • Runny nose
    • Sneezing
    • Itchy, watery eyes
    • Itchy nose or throat

    For Indoor & outdoor allergies

    Non-drowsy

    Caplets**

    (**Capsule-shaped tablets)

    *This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 Hour.

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Manufactured for FSA Stores Inc.

    5473 BLAIR ROAD

    SUITE 100

    PMB 24308

    DALLAS, TX 75231

  • Product Label

    Antihistamine

    Caring Mill - Allergy Relief Fexofenadine HCl Tablets, 180 mg

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    fexofenadine hcl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81522-613
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorwhite (peach) Scoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code G6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81522-613-301 in 1 BOX10/08/2021
    130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21107510/08/2021
    Labeler - FSA Store Inc. (Caring Mills) (049283340)
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