Label: ALLERGY RELIEF- fexofenadine hydrochloride tablet 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 12/12

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

  • Active ingredient (in each tablet)

    Fexofenadine HCl 180 mg

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  • Purpose

    Antihistamine

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  • 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
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  • 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.

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  • 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
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  • Other information

    • store at 20°-25°C (68°-77°F)
    • protect from excessive moisture
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  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone k-30, talc, titanium dioxide.

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  • Questions or comments?

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

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  • Package/Label Principal Display Panel

    †Compare to the active ingredient in Allegra® Allergy 24 hour

    ORIGINAL PRESCRIPTION STRENGTH

    NON-DROWSY

    ALLERGY RELIEF

    Fexofenadine HCl 180 mg

    Antihistamine

    ALLERGY

    Indoor and outdoor Allergies

    24 Hour Relief of:

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

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DO NOT USE IF CARTON IS OPEN OR IF INDIVIDUAL BLISTER UNIT IS TORN OR OPEN.

    Distributed by: PL Developments

    200 hicks street

    westbury NY 11590

    PRODUCT OF INDIA

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  • Product Label

    PL Developments

    Fexofenadine HCl 180 mg

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  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    fexofenadine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59726-189(NDC:55648-987)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE 180 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    HYPROMELLOSES  
    FERRIC OXIDE RED  
    FERRIC OXIDE YELLOW  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POVIDONE K30  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color WHITE (light peach) Score no score
    Shape CAPSULE Size 17mm
    Flavor Imprint Code W987
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59726-189-05 1 in 1 CARTON
    1 5 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079112 03/28/2013
    Labeler - P and L Development of New York Corporation (800014821)
    Registrant - P and L Development of New York Corporation (800014821)
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