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, 11523-7157-9
  • Packager: Bayer Healthcare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 6, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Loratadine 10 mg

  • Purpose

    Antihistamine

  • 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

    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.

  • Directions

    • place 1 tablet on tongue; tablet disintegrates, with or without water
    adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours
    children under 6 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor
  • 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
  • Inactive ingredients

    anhydrous citric acid, gelatin, mannitol, mint flavor

  • Questions or comments?

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

  • 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.

  • 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
  • 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
  • INGREDIENTS AND APPEARANCE
    CLARITIN  REDITABS
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7157
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    MANNITOL (UNII: 3OWL53L36A)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GELATIN (UNII: 2G86QN327L)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorMINTImprint Code C10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-7157-21 in 1 CARTON11/27/2002
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11523-7157-33 in 1 CARTON11/27/2002
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:11523-7157-42 in 1 CARTON11/27/2002
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:11523-7157-74 in 1 CARTON11/27/2002
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:11523-7157-85 in 1 CARTON11/27/2002
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:11523-7157-97 in 1 CARTON11/27/2002
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02070411/27/2002
    CLARITIN  REDITABS
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4329
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GELATIN (UNII: 2G86QN327L)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorMINTImprint Code C10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-4329-12 in 1 PACKAGE, COMBINATION11/27/2002
    13 in 1 CARTON
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11523-4329-26 in 1 CARTON11/27/2002
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02070411/27/2002
    Labeler - Bayer Healthcare LLC. (112117283)
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