Label: CURIST ALLERGY RELIEF- loratadine tablet

  • NDC Code(s): 72559-005-02, 72559-005-04
  • Packager: Little Pharma, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 13, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Loratadine 10 mg

  • PURPOSE

    Purpose

    Antihistamine

  • INDICATIONS & USAGE

    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
  • 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 you 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

    Directions

    adults and children 6 years and over

    1 tablet daily; not more than 1 tablet in 24 hours

    children under 6 years of age

    ask a doctor

    consumers with liver and kidney disease

    ask a doctor
  • STORAGE AND HANDLING

    Other information

    • TAMPER EVIDENT: do not use if imprinted seal under cap is missing or broken
    • store between 20° and 25°C (68° and 77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

  • QUESTIONS

    Questions or comments? Call 1-800-540-3765

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Little Pharma, Inc., New York, NY 10023

  • PRINCIPAL DISPLAY PANEL

    curist

    Allergy Relief
    Loratadine Tablets, 10 mg

    Antihistamine

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

    30 Tablets

    032719 Curist Loratadine Box

  • INGREDIENTS AND APPEARANCE
    CURIST ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72559-005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize8mm
    FlavorImprint Code L612
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72559-005-021 in 1 CARTON06/11/2019
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:72559-005-0425 in 1 CARTON03/27/201906/11/2019
    21 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07630103/27/2019
    Labeler - Little Pharma, Inc. (074328189)
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