Label: ALLERGY RELIEF- loratadine capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 11, 2024

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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.

  • Questions or comments?

    1-844-705-4384

  • PRINCIPAL DISPLAY PANEL

    Premier Value®

    COMPARE TO THE ACTIVE INGREDIENT IN CLARITIN® LIQUI-GELS®†

    *When taken as directed. 

    See Drug Facts Panel.

    NON-DROWSY*

    Allergy Relief

    LORATADINE 10 MG • 24 HOUR RELIEF

    ANTIHISTAMINE

    Relieves:

    • Sneezing

    • Runny Nose

    • Itchy, Watery Eyes

    • Itchy Throar or Nose

    Indoor  Outdoor Allergies

    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:68016-055
    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:68016-055-101 in 1 CARTON12/01/201807/31/2025
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20621412/01/201807/31/2025
    Labeler - CHAIN DRUG CONSORTIUM (101668460)
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