Label: CURIST ALLERGY RELIEF- loratadine 10 mg tablet

  • NDC Code(s): 72559-033-47, 72559-033-48
  • Packager: Little Pharma, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 12, 2023

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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
    • 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

    Directions

    adults and children 6 years
    and over     		1 tablet daily; not more
    than 1 tablet in 24 hours
    children under 6 years of ageask a doctor
    consumers with liver or kidney
    disease     		ask a doctor

  • STORAGE AND HANDLING

    Other information

    • store between 20° and 25°C (68° and 77° F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    Lactose monohydrate, magnesium stearate, sodium starch glycolate, starch maize pregelatinized

  • QUESTIONS

    Questions or comments?

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

  • SPL UNCLASSIFIED SECTION

    curistrelief.com

    *When taken as directed. See Drug Facts Panel.
    TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.

  • SPL UNCLASSIFIED SECTION

    (CONTINUED ON BACK OF LABEL)

    Distributed by: Little Pharma, Inc., New York, NY 10023
    Made in India | NDC: 72559-033-48
    Compare to active ingredient in Claritin®**

    PEEL HERE

  • SPL UNCLASSIFIED SECTION

    **This product is not manufacutred or distributed by the owner/distributor of Claritin®

    REV: 033-48-01

    STOP PEELING

  • PRINCIPAL DISPLAY PANEL

    curist

    Allergy Relief

    Loratadine Tablets USP, 10 mg

    Antihistamine

    Indoor and Outdoor Allergies
    24 Hour Relief of Runny Nose;
    Sneezing; Itchy, Watery Eyes;
    Itchy Nose or Throat
    Non-Drowsy*

    365 Tablets

    loratadine artwork

  • INGREDIENTS AND APPEARANCE
    CURIST ALLERGY RELIEF 
    loratadine 10 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72559-033
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code G;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72559-033-48365 in 1 BOTTLE; Type 0: Not a Combination Product12/12/2023
    2NDC:72559-033-4790 in 1 BOTTLE; Type 0: Not a Combination Product12/12/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21072212/12/2023
    Labeler - Little Pharma, Inc. (074328189)
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