Label: WAL-ITIN- loratadine capsule, liquid filled

  • NDC Code(s): 0363-1686-07, 0363-1686-30
  • Packager: WALGREENS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 11, 2022

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredient (in each capsule)

    Loratadine 10 mg

  • PURPOSE

    Purpose

    Antihistamine

  • INDICATIONS & USAGE

    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

    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)

  • DOSAGE & ADMINISTRATION

    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 SAFETY INFORMATION

    Other information

    • store between 20-25°C (68-77°F)
    • protect from freezing
  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Questions or comments?

    call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    686T-Walgreens-Loratadine-carton-label-30sNDC-0363-1686

  • INGREDIENTS AND APPEARANCE
    WAL-ITIN 
    loratadine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1686
    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)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize3mm
    FlavorImprint Code 21
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1686-0710 in 1 BLISTER PACK; Type 0: Not a Combination Product10/21/2016
    2NDC:0363-1686-303 in 1 CARTON10/21/2016
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20621410/21/2016
    Labeler - WALGREENS (008965063)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(0363-1686)
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