Label: ALLERGY RELIEF- loratadine capsule, liquid filled

  • NDC Code(s): 63868-669-10
  • Packager: CHAIN DRUG MARKETING ASSOCIATION INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 3, 2019

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

  • Active Ingredient (in each capsule)


    Loratadine  10mg



  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • runny nose

    • sneezing

    • itchy, water 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 children6 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

    • store between 20-25˚C (68-77˚F)

    • protect from freezing

    • retain carton for complete product information

  • Inactive ingredients

    FD&C blue #1, gelatin, mono and diglyceride of caprilic/capric acid, pharmaceutical ink, polysorbate 80, povidone, purified water, sorbitol, sorbitan solution.

  • Questions or Comments?

    1-844-705-4384

  • PRINCIPAL DISPLAY PANEL

    Quality Choice®

    NDC 63868-669-10

    *Compare to the Active Ingredient in CLARITIN® Liqui-Gels®

    Non-Drowsy†

    Allergy Relief

    Loratadine 10 mg | Antihistamine

    Indoor & Outdoor Allergies

    Relief of:

    Sneezing | Runny Nose

    Itchy, Watery Eyes

    Itchy Throat or Nose

    24 Hour

    †When taken as directed. See Drug Facts Panel.

    10 Softgels**

    **Liquid-Filled Capsules

    image description

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    loratadine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-669
    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)  
    CAPRIC ACID (UNII: 4G9EDB6V73)  
    POVIDONE K30 (UNII: U725QWY32X)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    Colorblue (Light Blue) Scoreno score
    ShapeOVAL (oval shaped) Size3mm
    FlavorImprint Code 21
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-669-101 in 1 CARTON09/01/2018
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20621409/01/2018
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC. (011920774)