Label: CURIST ALLERGY RELIEF- fexofenadine hydrochloride tablet, film coated

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 26, 2019

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

  • OTHER SAFETY INFORMATION

    Important: Read the directions and warnings before use.

    Tamper Evident: Do not use if imprinted inner safety seal is broken or missing.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each film-coated tablet)

    Fexofenadine HCl USP, 180 mg

  • PURPOSE

    Purpose

    Antihistamine

  • INDICATIONS & USAGE

    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

    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 and 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.

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet 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

  • STORAGE AND HANDLING

    Other information

    • store between 20° and 25°C (68° and 77°F)
    • protect from excessive moisture
    • each tablet contains: sodium 8.2 mg
    • this product meets the requirements of USP Dissolution Test 2
  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • QUESTIONS

    Questions? call 1-877-770-3183

    Weekdays 9:00 AM to 4:30 PM EST

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Little Pharma, Inc. New York, NY 10023

    Made in India

  • PRINCIPAL DISPLAY PANEL

    curist

    Allergy Relief

    Fexofenadine Hydrochloride Tablets, USP 180 mg

    Antihistamine

    24 Hour Relief of Runny Nose; Sneezing; Itchy, Watery Eyes; Itchy Nose or Throat

    30 Tablets

    72559-004 Fexofenadine

  • INGREDIENTS AND APPEARANCE
    CURIST ALLERGY RELIEF 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72559-004
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorpinkScore2 pieces
    ShapeOVAL (Capsule shaped, biconvex) Size17mm
    FlavorImprint Code SG;202
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72559-004-021 in 1 CARTON06/26/2019
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20450706/26/2019
    Labeler - Little Pharma, Inc. (074328189)