Label: CLARITIN- loratadine tablet

  • NDC Code(s): 11523-1527-1, 11523-1527-2, 11523-4359-1, 11523-4359-2, view more
    11523-4359-3, 11523-4359-4, 11523-4359-5, 11523-4359-6, 11523-4359-7, 11523-4359-8, 11523-4359-9, 11523-7160-1, 11523-7160-2, 11523-7160-3, 11523-7160-5, 11523-7160-6, 11523-7160-7, 11523-7160-8, 11523-7160-9, 11523-7237-1, 11523-7237-3, 11523-7237-5, 11523-7237-6, 11523-7237-7, 11523-7237-8, 11523-7237-9
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 10, 2020

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

  • 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

    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 (Blister foil units)

    • safety sealed: do not use if the individual blister unit imprinted with Claritin ® is open or torn
    • store between 20° to 25°C (68° to 77°F)
    • protect from excessive moisture
  • Other information (Bottles)

    • Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
    • store between 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    corn starch, lactose monohydrate, magnesium stearate

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL - 10 Tablet Carton

    Original Prescription

    Strength

    Non-Drowsy*

    Claritin®

    loratadine tablets 10 mg/antihistamine

    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.

    10 Tablets

    10 count carton

  • PRINCIPAL DISPLAY PANEL - 45 Count Window Box

    Original Prescription Strength

    Non-Drowsy *

    Claritin ®

    loratadine tablets 10 mg/antihistamine



    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.

    45 TABLETS

    Carton box 45

  • PRINCIPAL DISPLAY PANEL - 50 Tablet Carton

    Non-Drowsy*

    Claritin®

    loratadine tablets 10 mg/antihistamine

    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.

    50 1-Count Pouches

    Total 50 Tablets

    Dump bin 1Dump bin 2

  • INGREDIENTS AND APPEARANCE
    CLARITIN 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7237
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 458;Claritin10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-7237-11 in 1 CARTON04/12/1993
    145 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:11523-7237-37 in 1 CARTON08/12/1993
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:11523-7237-51 in 1 BLISTER PACK04/12/1993
    390 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:11523-7237-63 in 1 CARTON04/12/1993
    45 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:11523-7237-74 in 1 CARTON04/12/1993
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:11523-7237-81 in 1 CARTON04/12/1993
    6108 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:11523-7237-91 in 1 CARTON10/05/2017
    790 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01965804/12/1993
    CLARITIN 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 458;Claritin10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-7160-11 in 1 CARTON04/12/1993
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11523-7160-21 in 1 CARTON04/12/1993
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:11523-7160-32 in 1 CARTON04/12/1993
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:11523-7160-53 in 1 CARTON04/12/1993
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:11523-7160-61 in 1 CARTON04/12/1993
    52 in 1 POUCH; Type 0: Not a Combination Product
    6NDC:11523-7160-71 in 1 POUCH04/12/1993
    61 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:11523-7160-91 in 1 CARTON04/12/1993
    760 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:11523-7160-81 in 1 CARTON09/01/2016
    860 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01965804/12/1993
    CLARITIN 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-1527
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 458;Claritin10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-1527-150 in 1 BOX04/12/1993
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:11523-1527-250 in 1 BOX04/12/1993
    21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01965804/12/1993
    CLARITIN 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4359
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 458;Claritin10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-4359-11 in 1 CARTON04/12/1993
    140 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:11523-4359-21 in 1 CARTON04/12/1993
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:11523-4359-31 in 1 CARTON11/01/2017
    390 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:11523-4359-41 in 1 CARTON02/15/2019
    455 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:11523-4359-51 in 1 CARTON02/15/2019
    585 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:11523-4359-61 in 1 CARTON12/01/2019
    6110 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:11523-4359-82 in 1 BLISTER PACK04/12/1993
    760 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:11523-4359-91 in 1 CARTON12/01/2019
    835 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:11523-4359-71 in 1 BLISTER PACK04/12/1993
    9115 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01965804/12/1993
    Labeler - Bayer HealthCare LLC. (112117283)