Label: CLARITIN  REDITABS- loratadine tablet, orally disintegrating 

  • NDC Code(s): 11523-7202-1, 11523-7202-3
  • Packager: MSD Consumer Care, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/14

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Loratadine 5 mg

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  • Purpose

    Antihistamine

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  • 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
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  • 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.

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  • Directions

    • place 1 tablet on tongue; tablet disintegrates, with or without water
    adults and children 6 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours
    children under 6 years of age ask a doctor
    consumers with liver or kidney disease ask a doctor
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  • Other information

    • safety sealed: do not use if the individual blister unit imprinted with Claritin® RediTabs® is open or torn
    • store between 20° to 25°C (68° to 77°F)
    • use tablet immediately after opening individual blister
    • complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration
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  • Inactive ingredients

    anhydrous citric acid, gelatin, mannitol, mint flavor

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  • Questions or comments?

    1-800-CLARITIN (1-800-252-7484) or www.claritin.com

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  • SPL UNCLASSIFIED SECTION

    Distributed by MSD Consumer Care, Inc.,
    PO Box 377, Memphis, TN 38151 USA,
    a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ USA.

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  • PRINCIPAL DISPLAY PANEL - 10 Tablet Carton

    NDC 11523-7202-3

    Non-Drowsy*
    Claritin®
    RediTabs®

    loratadine 5 mg/antihistamine

    Indoor & Outdoor
    Allergies

    *When taken as directed. See Drug Facts Panel.

    12
    Hour

    Relief of:

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Throat
      or Nose

    No Water Needed
    Melts in Your Mouth

    10
    ORALLY
    DISINTEGRATING TABLETS

    PRINCIPAL DISPLAY PANEL - 10 Tablet Carton
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  • INGREDIENTS AND APPEARANCE
    CLARITIN   REDITABS
    loratadine tablet, orally disintegrating
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11523-7202
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Loratadine (Loratadine) Loratadine 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid  
    gelatin  
    mannitol  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND (flat faced beveled edge) Size 12mm
    Flavor MINT Imprint Code C5
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11523-7202-1 3 in 1 CARTON
    1 10 in 1 BLISTER PACK
    2 NDC:11523-7202-3 1 in 1 CARTON
    2 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021993 12/12/2006
    Labeler - MSD Consumer Care, Inc. (968091715)
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