Label: LEADER LORATADINE- loratadine tablet

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

Drug Label Information

Updated March 19, 2012

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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.

  • 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

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

    corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

  • QUESTIONS?

    call 1-800-406-7984

    Keep the carton. It contains important information.

    See end panel for expiration date.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

    NDC 37205-346-52

    LEADER®

    Compare to Claritin®active ingredient†

    Non-Drowsy*

    ORIGINAL PRESCRIPTION STRENGTH

    Loratadine

    Loratadine Tablets USP, 10 mg/Antihistamine

    Indoor & Outdoor Allergies

    24 Hour Allergy Relief

    Relief of:

    Sneezing

    Runny Nose

    Itchy, Watery Eyes

    Itchy Throat or Nose

    *When taken as directed. See Drug Facts Panel.

    10 TABLETS

    †Thisproduct is not manufactured or distributed by Schering-Plough HealthCare Products, Inc.,owner of theregisteredtrademarkClaritin®.

    This is the 10 count blister carton label for Leader Loratadine tablets USP, 10 mg.

    10's Blister Carton

    This is the 90 count bottle carton label for Leader Loratadine tablets USP, 10 mg.

    90's Bottle Carton

  • INGREDIENTS AND APPEARANCE
    LEADER LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-346
    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)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code RX526
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-346-5210 in 1 BLISTER PACK
    2NDC:37205-346-6020 in 1 BLISTER PACK
    3NDC:37205-346-6530 in 1 BLISTER PACK
    4NDC:37205-346-7260 in 1 BOTTLE
    5NDC:37205-346-7590 in 1 BOTTLE
    6NDC:37205-346-47150 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07613408/19/2003
    Labeler - Cardinal Health (097537435)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.051565745manufacture(37205-346)
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