Label: LEADER ALLERGY RELIEF D-24- loratadine and pseudoephedrine sulfate tablet, film coated, extended release

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

Drug Label Information

Updated March 21, 2012

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  • ACTIVE INGREDIENTS (IN EACH TABLET)

    Loratadine, USP 10 mg

    Pseudoephedrine sulfate, USP 240 mg

  • PURPOSE

    Antihistamine

    Nasal decongestant

  • USES

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • sneezing
      • itchy, watery eyes
      • runny nose
      • itching of the nose or throat
    • reduces swelling of nasal passages
    • temporarily relieves sinus congestion and pressure
    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • temporarily restores freer breathing through the nose
  • WARNINGS

    Do not use

    • if you have ever had an allergic reaction to this product or any of its ingredients
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • heart disease
    • thyroid disease
    • high blood pressure
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • 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.
    • symptoms do not improve within 7 days or are accompanied by a fever
    • nervousness, dizziness or sleeplessness occurs

    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

    • do not divide, crush, chew or dissolve the tablet
    adults and children 12 years and over1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours
    children under 12 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor
  • OTHER INFORMATION

    • sodium: contains 10 mg/tablet
    • calcium: contains 25 mg/tablet
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle cartons/labels only)
    • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only)
    • store between 20° C to 25° C (68° F to 77° F).
    • protect from light and store in a dry place
  • INACTIVE INGREDIENTS

    calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide

  • QUESTIONS?

    call 1-800-406-7984

    KEEP THE CARTON. IT CONTAINS IMPORTANT INFORMATION. SEE END PANEL FOR EXPIRATION DATE.

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 4301

    www.myleader.com 1-800-200-6313

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    NDC 37205-348-52

    LEADER®

    †Compare to Claritin-D® 24 Hour active ingredients

    24 Hour

    Non-Drowsy*

    ORIGINAL PRESCRIPTION STRENGTH

    Allergy Relief D-24

    Loratadine, USP 10 mg/Antihistamine

    Pseudoephedrine Sulfate, USP 240 mg/ Nasal Decongestant

    Indoor & Outdoor Allergies

    Allergy & Congestion

    Relief of:

    Nasal & Sinus CongestionDue to Colds or Allergies

    Sneezing; Runny Nose; Itchy, Watery Eyes, Itchy Throat or Nose Due to Allergies

    *When taken as directed. See Drug Facts Panel.

    10 EXTENDED-RELEASE TABLETS

    †The product is not manufactured or distributed by Schering-Plough Healthcare Products, Inc. CLARITIN-D® 24 HOUR is a registered trademark of Schering Corporation.

    lorad

    10's blister carton

  • INGREDIENTS AND APPEARANCE
    LEADER ALLERGY RELIEF D-24 
    loratadine and pseudoephedrine sulfate tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-348
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE240 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code RX724
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-348-5210 in 1 BLISTER PACK
    2NDC:37205-348-8815 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07655711/17/2004
    Labeler - Cardinal Health (097537435)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.051565745manufacture
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