Label: ALLERGY RELIEF- loratadine capsule, liquid filled

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

Drug Label Information

Updated October 8, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 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

    • Store between 20-25˚C (68-77˚F)

    • protect from freezing

    • retain carton for complete information and warnings

  • Inactive ingredients

    FD&C Blue no. 1, gelatine, mono anddiglyceride of caprilic/capric acid, pharmaceutical ink, polysorbate 80,povidone, purified water, sorbitol, sorbitan solution.

  • PRINCIPAL DISPLAY PANEL

    Signature Care

    Quality Guaranteed

    Compare to Claritin(R) Liqui-Gels(R) active ingredient

    NDC 21130-195-02

    24 Hour

    Allergy Relief

    Liquid-Gels

    LORATADINE 10mg / Antihistamine

    Indoor and Outdoor Allergies

    Non-Drowsy*

    Actual Size

    Relief of

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

    *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:21130-195
    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:21130-195-021 in 1 CARTON10/01/2019
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20621410/01/2019
    Labeler - Safeway (009137209)
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