Label: CURIST CHILDRENS ALLERGY RELIEF- loratadine 5 mg chewable tablets tablet, chewable

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

Drug Label Information

Updated September 3, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each chewable tablet)

    Loratadine USP, 5 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 liver or kidney disease. Your doctor should determine if you need a different dose.

    When using this product do not take more than directed. Taking more than directed may cause drowsiness.

    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 (1-800-222-1222).

  • DOSAGE & ADMINISTRATION

    • chew or crush tablets completely before swallowing.

    adults and children 6 years and overchew 2 tablets daily; not more than 2 chewable tablets in 24 hours
    children 2 to under 6 years of agechew 1 tablet daily; not more than 1 chewable tablets in 24 hours
    children under 2 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor

  • STORAGE AND HANDLING

    Other information

    • phenylketonurics: contains phenylalanine 1.25 mg per tablet.
    • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
    • store between 20º to 25ºC (68º to 77ºF).
  • INACTIVE INGREDIENT

    Inactive ingredients

    aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

  • QUESTIONS

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

  • SPL UNCLASSIFIED SECTION

    Keep the carton. It contains important information. See end panel for expiration date.

  • SPL UNCLASSIFIED SECTION

    REV: 031-43-01

    NDC: 72559-031-43

    Distributed by: Little Pharma, Inc.

    New York, NY 10023

    Tableted and Packaged in USA

  • PRINCIPAL DISPLAY PANEL

    curist kids

    Children's Allergy Relief

    Loratadine Chewable Tablets USP, 5 mg

    Antihistamine

    Indoor and Outdoor Allergies

    24 Hour Relief of Sneezing;

    Runny Nose; Itchy, Watery Eyes;

    Itchy Throat or Nose

    Non-Drowsy*

    60 CHEWABLE TABLETS

    The chewable tablets are to be chewed before swallowing.

    AGES 2+ YEARS

    *When taken as directed. See Drug Facts Panel.

    Grape Flavored

    Dye-Free

    curistrelief.com

    Loratadine Chewable Image

  • INGREDIENTS AND APPEARANCE
    CURIST CHILDRENS ALLERGY RELIEF 
    loratadine 5 mg chewable tablets tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72559-031
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeROUND (bevelled edge) Size10mm
    FlavorGRAPEImprint Code 106
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72559-031-436 in 1 CARTON06/12/2024
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21008806/12/2024
    Labeler - Little Pharma, Inc. (074328189)
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