Label: CLARITIN LIQUI-GELS- loratadine capsule, liquid filled

  • NDC Code(s): 11523-7200-1, 11523-7200-2, 11523-7200-3, 11523-7200-4, view more
    11523-7200-5, 11523-7200-6, 11523-7200-7, 11523-7200-8, 11523-7200-9, 11523-7333-1, 11523-7333-3, 11523-7333-4, 11523-7333-5
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 15, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each capsule)

    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 capsule daily; not more than 1 capsule 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® Liqui-Gels® is open or torn
    • store between 20° to 25°C (68° to 77°F)
    • protect from freezing
  • Inactive ingredients

    caprylic/capric glycerides, FD&C blue no.1, gelatin, glycerin, pharmaceutical ink, polysorbate 80, povidone, purified water, sorbitol

  • Questions or comments?

    1-800-CLARITIN (1-800-252-7484)

  • SPL UNCLASSIFIED SECTION

    Pat.: patents.livewell.bayer.com

    Bayer, the Bayer Cross, Claritin and the Claritin Vista are registered trademarks of Bayer.

    © 2023 Bayer. Dist by: Bayer HealthCare LLC

    Whippany, NJ 07981


    LIQUI-GELS is a registered trademark of Catalent Pharma Colutions, Inc.

  • PRINCIPAL DISPLAY PANEL - 30 Capsule Carton

    Non-Drowsy*

    Claritin     ®

    Liqui-Gels®

    24

    Hour

    Relief of:

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

    loratadine 10 mg/antihistamine

    Indoor & Outdoor Allergies

    Allergies

    *When taken as directed.

    See Drug Facts Panel.

    30 LIQUID-FILLED

    CAPSULES

    Claritin Carton

  • 30 Count DFL

    Claritin DFL

  • INGREDIENTS AND APPEARANCE
    CLARITIN  LIQUI-GELS
    loratadine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorblue (Clear Blue) Scoreno score
    ShapeCAPSULESize10mm
    FlavorImprint Code C;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-7200-11 in 1 CARTON06/16/2008
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11523-7200-23 in 1 CARTON06/16/200801/01/2016
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:11523-7200-34 in 1 CARTON06/16/200801/01/2016
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:11523-7200-51 in 1 POUCH; Type 0: Not a Combination Product06/16/200801/01/2016
    5NDC:11523-7200-47 in 1 CARTON06/16/200801/01/2016
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:11523-7200-63 in 1 CARTON06/16/2008
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:11523-7200-75 in 1 CARTON06/16/200801/01/2016
    79 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:11523-7200-84 in 1 CARTON06/16/2008
    810 in 1 BLISTER PACK; Type 0: Not a Combination Product
    9NDC:11523-7200-96 in 1 CARTON06/16/2008
    910 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02195206/16/2008
    CLARITIN  LIQUI-GELS
    loratadine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7333
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    GELATIN (UNII: 2G86QN327L)  
    Product Characteristics
    Colorblue (Clear Blue) Scoreno score
    ShapeCAPSULESize10mm
    FlavorImprint Code C;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-7333-11 in 1 CARTON06/16/2008
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11523-7333-34 in 1 CARTON06/16/2008
    29 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:11523-7333-47 in 1 CARTON06/16/2008
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:11523-7333-510 in 1 CARTON06/16/2008
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02195206/16/2008
    Labeler - Bayer HealthCare LLC. (112117283)
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