Label: CLARITIN REDITABS- loratadine tablet, orally disintegrating

  • NDC Code(s): 11523-4329-1, 11523-4329-2, 11523-7157-2, 11523-7157-3, view more
    11523-7157-4, 11523-7157-7, 11523-7157-8
  • Packager: Bayer Healthcare LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 2, 2016

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 10 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 daily; not more than 1 tablet 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

    Original Prescription Strength
    NDC 11523-7157-2

    Non-Drowsy*
    Claritin
    ®
    RediTabs®
    loratadine 10 mg/antihistamine

    Indoor & Outdoor
    Allergies

    *When taken as directed. See Drug Facts Panel.

    24
    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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  • PRINCIPAL DISPLAY PANEL - 60 Tablet Twin Pack Carton

    TWIN PACK

    Two 30ct Cartons
    60 RediTabs
    ®

    Original Prescription Strength

    NDC 11523-4329-1

    Non-Drowsy*
    Claritin
    ®
    RediTabs®
    loratadine 10 mg/antihistamine

    Indoor & Outdoor
    Allergies

    *When taken as directed. See Drug Facts Panel.

    24
    Hour

    Relief of:

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

    No Water Needed
    Melts in Your Mouth

    60
    ORALLY
    DISINTEGRATING TABLETS

    PRINCIPAL DISPLAY PANEL - 60 Tablet Twin Pack Carton
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  • INGREDIENTS AND APPEARANCE
    CLARITIN  REDITABS
    loratadine tablet, orally disintegrating
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-7157
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GELATIN (UNII: 2G86QN327L)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 12mm
    Flavor MINT Imprint Code C10
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11523-7157-2 1 in 1 CARTON 11/27/2002
    1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:11523-7157-3 3 in 1 CARTON 11/27/2002
    2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:11523-7157-4 2 in 1 CARTON 11/27/2002
    3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4 NDC:11523-7157-7 4 in 1 CARTON 11/27/2002
    4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5 NDC:11523-7157-8 5 in 1 CARTON 11/27/2002
    5 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020704 11/27/2002
    CLARITIN  REDITABS
    loratadine tablet, orally disintegrating
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-4329
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GELATIN (UNII: 2G86QN327L)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 12mm
    Flavor MINT Imprint Code C10
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11523-4329-1 2 in 1 PACKAGE, COMBINATION 11/27/2002
    1 3 in 1 CARTON
    1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:11523-4329-2 6 in 1 CARTON 11/27/2002
    2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020704 11/27/2002
    Labeler - Bayer Healthcare LLC (968091715)
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