WAL ITIN (LORATADINE) TABLET [WALGREEN COMPANY]

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WAL ITIN (LORATADINE) TABLET [WALGREEN COMPANY]
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NDC 0363-0699-03, 0363-0699-46, 0363-0699-47, 0363-0699-58, 0363-0699-60, 0363-0699-65, 0363-0699-72, 0363-0699-75, 0363-0699-87, 0363-0699-95
Set ID 84d752d2-33e4-4b69-a015-8b744f5f8d3c
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number ANDA076301
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  • Active ingredient (in each tablet)

    Loratadine 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

    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

    •
    do not use if blister unit is broken or torn
    •
    store between 20° to 25°C (68° to 77°F)
    •
    protect from excessive moisture
  • Inactive ingredients

    lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    NON-DROWSY* • ORIGINAL PRESCRIPTION STRENGTH

    Wal-itin®

    Compare to Claritin® Tablets active ingredient

    24 HOUR ALLERGY

    LORATADINE TABLETS 10 mg / ANTIHISTAMINE

    24 HOUR TABLETS

    INDOOR & OUTDOOR ALLERGIES

    24-hour relief of sneezing; runny nose; itchy, watery eyes & itchy throat or nose

    10 days of relief

    10 TABLETS

    24 HOUR

    ACTUAL SIZE

    *WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

    612-94-wal-itin.jpg
  • INGREDIENTS AND APPEARANCE
    WAL ITIN 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0699
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize8mm
    FlavorImprint Code L612
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0699-4610 in 1 CARTON02/13/2009
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-0699-6020 in 1 CARTON02/19/2009
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0363-0699-651 in 1 CARTON02/17/2009
    330 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0363-0699-951 in 1 CARTON05/01/2013
    445 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0363-0699-721 in 1 CARTON03/10/2009
    560 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0363-0699-031 in 1 CARTON02/04/2014
    670 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0363-0699-751 in 1 CARTON03/10/2009
    790 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:0363-0699-471 in 1 CARTON03/21/2009
    8150 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:0363-0699-871 in 1 CARTON02/04/2011
    9300 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:0363-0699-581 in 1 CARTON08/22/2016
    1040 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07630102/13/2009
    Labeler - Walgreen Company (008965063)
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