Label: CLARITIN REDITABS- loratadine tablet, orally disintegrating

  • NDC Code(s): 11523-7202-1, 11523-7202-3
  • Packager: Bayer HealthCare LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 10, 2023

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Loratadine 5 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 every 12 hours; not more than 2 tablets 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

    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

    front labelback carton label

  • INGREDIENTS AND APPEARANCE
    CLARITIN  REDITABS
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7202
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GELATIN (UNII: 2G86QN327L)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (flat faced beveled edge) Size12mm
    FlavorMINTImprint Code C5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-7202-13 in 1 CARTON12/12/2006
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11523-7202-31 in 1 CARTON12/12/2006
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02199312/12/2006
    Labeler - Bayer HealthCare LLC (112117283)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!