Label: CLARITIN- loratadine tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 7, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Loratadine, USP 10 mg

  • Purpose

    Antihistamine

  • 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

    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).

  • 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 diseaseask a doctor
  • Other information

    • store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature)
  • Inactive ingredients

    lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

  • Questions or comments?

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

  • SPL UNCLASSIFIED SECTION

    Dist by: Bayer HealthCare LLC
    Whippany, NJ 07981

  • PRINCIPAL DISPLAY PANEL - 10 mg Pouch Blister Pack

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

    Original Prescription Strength

    24
    Hour

    Relief of:

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

    Indoor & Outdoor
    Allergies

    *When taken as directed.
    See Drug Facts Panel.

    1 Tablet

    PRINCIPAL DISPLAY PANEL - 10 mg Pouch Blister Pack
  • INGREDIENTS AND APPEARANCE
    CLARITIN 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-630(NDC:11523-7160)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    loratadine (UNII: 7AJO3BO7QN) (loratadine - UNII:7AJO3BO7QN) loratadine10 mg
    Inactive Ingredients
    Ingredient NameStrength
    lactose monohydrate (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    magnesium stearate (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 458;Claritin10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-630-031 in 1 BLISTER PACK12/15/2011
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:52904-630-2020 in 1 CARTON12/15/2011
    21 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:52904-630-2525 in 1 CARTON12/15/2011
    31 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01965812/15/2011
    Labeler - Select Corporation (053805599)
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