Label: FEXOFENADINE HCL tablet, film coated

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

Drug Label Information

Updated May 31, 2018

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  •     HIVES Active ingredient (in each film-coated tablet)

    Fexofenadine HCl USP 60 mg

    Fexofenadine HCl USP 180 mg

  • Purpose

    Antihistamine

  • INDICATIONS & USAGE

    Uses

    reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

  • Warnings

    Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

    •
    trouble swallowing
    •
    dizziness or loss of consciousness
    •
    swelling of tongue
    •
    swelling in or around mouth
    •
    trouble speaking
    •
    drooling
    •
    wheezing or problems breathing

    These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health profession immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

    Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

    Do not use

    to prevent hives from any known cause such as:

    •
     foods
    •
    insect stings
    •
    medicines
    •
    latex or rubber gloves

    because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

    •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.
    •
    hives that are an unusual color, look bruised or blistered
    •
    hives that do not itch

    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.
    •
    symptoms do not improve after 3 days of treatment
    •
    the hives have lasted more than 6 weeks

    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 (for 60mg)

    adults and children 12 years of age and over

    take one 60mg tablet with water every 12 hours; do not take more than 2 tablets 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
  • Directions (for 180mg)

    adults and children 12 years of age and over

    take one 180mg 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° and 25°C (68° and 77°F)
    •
    protect from excessive moisture
    •
    each tablet contains: sodium 2.7mg(for 60 mg), sodium 8.2mg(for 180 mg)
    •
    this product meets the requirements of USP Dissolution Test 2
    •
    Tamper Evident: Do not use if imprinted inner safety seal is torn or missing
  • Inactive ingredients

    anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch(maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide titanium dioxide and yellow iron oxide.

  • Questions or comments?

    Call toll-free 1-855-724-3436

    Manufactured by:

    ScieGen Pharmaceuticals, Inc.

    Hauppauge, NY 11788 USA

    Marketed/Packaged by:

    GSMS, Inc. 

    Camarillo, CA 93012 USA

  •                              ALLERGY Active ingredient (in each film-coated tablet)

    Fexofenadine HCl USP 60 mg

    Fexofenadine HCl USP 180 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.

  • Directions (for 60mg)

    adults and children 12 years of age and over

    take one 60mg tablet with water every 12 hours; do not take more than 2 tablets 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
  • Directions (for 180mg)

    adults and children 12 years of age and over

    take one 180mg 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° and 25°C (68° and 77°F)
    •
    protect from excessive moisture
    •
    each tablet contains: sodium 2.7mg(for 60 mg), sodium 8.2mg(for 180 mg)
    •
    this product meets the requirements of USP Dissolution Test 2
    •
    Tamper Evident: Do not use if imprinted inner safety seal is torn or missing
  • Inactive ingredients

    anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch(maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide titanium dioxide and yellow iron oxide.

  • Questions or comments?

    Call toll-free 1-855-724-3436

  • Repackaging Information

    Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

    Count180 mg
    3071610-070-30

    Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

    Repackaged by:
    Aphena Pharma Solutions - TN
    Cookeville, TN 38506

    20180531JH

  • PRINCIPAL DISPLAY PANEL - 180 mg

    NDC 71610-070 - Fexofenadine HCl 180 mg - Rx Only
    Bottle Label 180 mg

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HCL 
    fexofenadine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-070(NDC:51407-034)
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code SG;202
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71610-070-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20450701/01/2018
    Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-070)
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