Label: SUNMARK LORATADINE ODT- loratadine tablet, orally disintegrating

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

Drug Label Information

Updated August 14, 2012

If you are a consumer or patient please visit this version.

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!