Label: SUNMARK LORATADINE ODT- loratadine tablet, orally disintegrating

  • NDC Code(s): 49348-929-04, 49348-930-01, 49348-930-44
  • Packager: Sunmark
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 14, 2012

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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 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

    • 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.
    • keep in a dry place.
    • use tablet immediately after opening individual blister.
  • INACTIVE INGREDIENTS

    aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate

  • QUESTIONS?

    call 1-800-406-7984

    Keep the carton. It contains important information.

    See end panel for expiration date.

    Distributed by McKesson

    One Post Street, San Francisco, CA 94104

    www.sunmarkbrand.com

  • PRINCIPAL DISPLAY PANEL

    sunmark®

    NDC 49348-930-01

    allergy relief

    24 HOUR

    loratadine Orally Disintegrating Tablets, 10 mg

    Antihistamine

    For adults and children six years and older

    Indoor & Outdoor Allergies

    Non-drowsy*

    Relief of sneezing; runny nose; itchy, watery eyes; itchy throat or nose

    MELTS IN YOUR MOUTH

    10 ORALLY DISINTEGRATING TABLETS

    *When taken as directed.

    See Drug Facts Panel.

    COMPARE TO CLARITIN®REDITABS®ACTIVE INGREDIENT

    The product is not manufactured or distributed by Schering-Plough Healthcare Products , Inc.

    CLARITIN®and REDITABS®are registered trademarks of Schering Corporation.

    This is the 10 count blister carton label for Sunmark Loratadine ODT, 10 mg.

    sunmark®

    NDC 49348-929-04

    allergy relief

    24 HOUR

    Loratadine Orally Disintegrating Tablets, 10 mg

    Antihistamine

    For adults and children six years and older

    Indoor & Outdoor Allergies

    Non-drowsy*

    Relief of sneezing; runny nose; itchy, watery eyes; itching of nose & throat

    MELTS IN YOUR MOUTH

    24 ORALLY DISINTEGRATING TABLETS

    *When taken as directed.

    See Drug Facts Panel.

    COMPARE TO ALAVERT®ACTIVE INGREDIENT

    The product is not manufactured or distributed by Wyeth Consumer Healthcare, owner of the registered trademark Alavert®.

    This is the 24 count blister carton label for Sunmark Loratadine ODT (Alavert).

  • INGREDIENTS AND APPEARANCE
    SUNMARK LORATADINE ODT 
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-930
    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
    FlavorSTRAWBERRY, TUTTI FRUTTI, MINTImprint Code RC17
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-930-0110 in 1 BLISTER PACK
    2NDC:49348-930-4430 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07715308/31/2007
    SUNMARK LORATADINE ODT 
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-929
    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
    FlavorSTRAWBERRY, TUTTI FRUTTI, MINTImprint Code RC17
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-929-0424 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07715308/31/2007
    Labeler - Sunmark (177667227)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.051565745manufacture(49348-930, 49348-929)