Label: CURIST ALLERGY RELIEF- fexofenadine hydrochloride 180 mg tablet

  • NDC Code(s): 72559-027-22, 72559-027-23, 72559-027-46
  • Packager: Little Pharma, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 22, 2024

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  • 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 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.

  • DOSAGE & ADMINISTRATION

    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

  • STORAGE AND HANDLING

    Other information

    • each tablet contains: sodium 8.2 mg
    • store between 20º and 25ºC (68º and 77ºF)
    • protect from excessive moisture
    • 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 INGREDIENT

    Inactive ingredients

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

  • QUESTIONS

    Questions or comments?

    Call 1-844-243-1241 or email hi@curistrelief.com

  • SPL UNCLASSIFIED SECTION

    Rev: 027-22-01

    Distributed by:

    Little Pharma, Inc.

    New York, NY 10023

    Made in USA with

    Globally Sourced Ingredients

    curistrelief.com

  • PRINCIPAL DISPLAY PANEL

    curist

    Allergy Relief

    Fexofenadine Hydrochloride

    Tablets, USP 180 mg

    Antihistamine

    24 Hour Reilef of Runny Nose; Sneezing;

    Itchy, Watery Eyes; Itchy Nose or Throat

    Indoor and Outdoor Allergies

    Non-Drowsy

    200 Tablets

    Allergy Relief label

  • INGREDIENTS AND APPEARANCE
    CURIST ALLERGY RELIEF 
    fexofenadine hydrochloride 180 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72559-027
    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
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code SG;202
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72559-027-22200 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2023
    2NDC:72559-027-23300 in 1 BOTTLE; Type 0: Not a Combination Product01/31/2024
    3NDC:72559-027-4630 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20450703/30/2023
    Labeler - Little Pharma, Inc. (074328189)
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