Label: LORATADINE capsule, liquid filled

  • NDC Code(s): 69452-211-03, 69452-211-07, 69452-211-16, 69452-211-26
  • Packager: Bionpharma Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 8, 2019

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

View All Sections
  • 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 over

     1 capsule daily; not more than 1 capsule in 24 hours

    children under 6 years of age

     ask a doctor

    consumers with liver or kidney disease

     ask a doctor

  • Other information

    • Tamper-evident: do not use if foil seal under cap, printed with “Sealed for your protection” is missing, open or broken. (For Bottle Labels and Cartons)
    • Safety sealed: do not use if individual blister unit printed with Loratadine Capsule, 10 mg is open or torn. (For Blister Carton)
    • store between 20° to 25°C (68° to 77°F)
    • protect from freezing
  • Inactive ingredients

    FD&C blue no.1, gelatin, glycerin, hypromellose, hydrolyzed collagen, isopropyl alcohol, mannitol, medium chain mono- & di-glycerides, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

  • Questions or comments?

    1-888-235-2466

    **This product in not manufactured or distributed by Bayer, owner of the registered trademark Claritin® and Catalent Pharma Solutions, Inc, owner of the registered trademark LIQUI-GELS®.

    Manufactured for:

    Bionpharma Inc.

    600 Alexander Road,

    Princeton, NJ 08540

    Rev # 07/17

  • Principal Display Panel

    NDC 69452-211-03

    Compare to the active ingredient in Claritin® Liqui-Gels®**

    Original Prescription Strenght

    Non-Drowsy*

    Loratadine Capsules, 10 mg

    Antihistamine

    Indoor & Outdoor Allergies

    24 hour

    Relief of:

    • Sneezing

    • Runny Nose

    • Itchy, Watery Eyes

    • Itchy Throat or Nose

    5 LIQUID-FILLED CAPSULES

    *When taken as directed. See Drug Facts Panel

    Do not use if carton is open, or if foil inner seal on bottle is broken

    5's Carton

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-211
    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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW) (UNII: 5WE8P977RQ)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MANNITOL (UNII: 3OWL53L36A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code 446
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69452-211-031 in 1 CARTON03/01/2019
    15 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69452-211-161 in 1 CARTON03/01/2019
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:69452-211-261 in 1 CARTON03/01/2019
    3200 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:69452-211-071 in 1 CARTON03/01/2019
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20253803/01/2019
    Labeler - Bionpharma Inc. (079637826)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Softgels Inc.002193829manufacture(69452-211)
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!