Label: LORATADINE tablet

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

Drug Label Information

Updated June 14, 2018

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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

    adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours
    children under 6 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor
  • OTHER INFORMATION

    • store between 20° to 25° C (68° to 77° F)
    • protect from excessive moisture
    • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • INACTIVE INGREDIENTS

    Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

  • QUESTIONS?

    Call 1-800-406-7984

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

  • PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton

    NON-DROWSY*
    Wal-itin®
    24 Hour Allergy
    Loratadine Tablets, USP 10 mg
    Antihistamine

    • Relief of runny nose,
      sneezing, itchy throat or nose &
      itchy, watery eyes

    5 TABLETS

    Actual Size

    Well at
    Walgreens
    WALGREENS PHARMACIST RECOMMENDED‡

    NDC 0363-0522-56

    INDOOR &
    OUTDOOR
    ALLERGIES

    24
    HOUR

    Compare to Claritin®
    active ingredient‡‡

    *WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

    PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0522
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorwhite (White to Off-White) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code RX526
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0522-711 in 1 CARTON12/05/2013
    170 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0363-0522-551 in 1 CARTON12/05/2013
    2150 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0363-0522-781 in 1 CARTON12/05/2013
    3300 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0363-0522-212 in 1 CARTON12/05/2013
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:0363-0522-691 in 1 CARTON12/05/2013
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:0363-0522-301 in 1 CARTON12/05/2013
    630 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0363-0522-431 in 1 CARTON12/05/2013
    745 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:0363-0522-561 in 1 CARTON12/05/2013
    85 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07613412/05/2013
    Labeler - Walgreen Company (008965063)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.051565745manufacture(0363-0522)
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