Label: LORATADINE tablet, orally disintegrating

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

Drug Label Information

Updated March 31, 2015

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  • ACTIVE INGREDIENT (IN EACH TABLET)

    Loratadine USP, 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 (1-800-222-1222).

  • DIRECTIONS

    •
    place 1 tablet on tongue; tablet disintegrates, with or without water

    adults and children 6 years and over

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

    children under 6 years of age

    ask a doctor

    consumers with liver or kidney disease

    ask a doctor
  • OTHER INFORMATION

    •
    Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
    •
    TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
    •
    store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
    •
    use tablet immediately after opening individual blister.
  • INACTIVE INGREDIENTS

    Aspartame, croscarmellose sodium, magnesium stearate, mannitol, mint flavor, sodium stearyl fumarate, strawberry cream flavor, tutti-frutti flavor

  • QUESTIONS?

    Call 1-800-406-7984

  • PRINCIPAL DISPLAY PANEL

    NON-DROWSY*

    Well at Walgreens

    NDC 0363-0527-71

    Wal-itin®

    WALGREENS PHARMACIST RECOMMENDED‡

    24 Hour Allergy Relief

    Fast Dissolving Tablets

    Loratadine Orally Disintegrating Tablets USP, 10 mg

    Antihistamine

    •
    Relief of runny nose, sneezing, Itchy throat or nose & Itchy, watery eyes
    •
    Ages 6 years & older

    70 TABLETS

    INDOOR/OUTDOOR ALLERGIES

    24 HOUR

    Compare to Claritin®RediTabs® active ingredient‡‡

    ORALLY DISINTEGRATING TABLETS

    *When taken as directed.

    See Drug Facts Panel.

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    5115100/ORG0315-F

    This is the 10 count blister carton label for Walgreens Loratadine ODT.
  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0527
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    Product Characteristics
    Colorwhite (White to Off-White) Scoreno score
    ShapeROUND (Flat Faced Beveled Edge) Size10mm
    FlavorFRUITImprint Code RC17
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0527-3130 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-0527-6910 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0363-0527-7170 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07715308/31/2007
    Labeler - Walgreen Company (008965063)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.051565745MANUFACTURE(0363-0527)
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