Label: LORATADINE tablet, orally disintegrating

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 28, 2012

If you are a healthcare professional or from the pharmaceutical industry 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 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

    • 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, magnesium stearate, mannitol, mint flavor, sodium stearyl fumarate, strawberry cream flavor, tutti-frutti flavor

  • QUESTIONS?

    call 1-888-423-0139

  • PRINCIPAL DISPLAY PANEL

    Topcare®

    NDC 36800-527-69

    MELT-IN-YOUR-MOUTH TABLETS. NO WATER NEEDED

    Original Prescription Strength

    24 HOUR NON-DROWSY*

    Allergy Relief

    LORATADINE ORALLY DISINTEGRATING TABLETS, USP 10 mg

    ANTIHISTAMINE

    Indoor & Outdoor Allergies

    For Adults and Children six years and older!

    For 24 Hour Relief of:

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itching Throat or Nose

    COMPARE TO CLARITIN®REDITABS®active ingredient†

    10 ORALLY DISINTEGRATING TABLETS

    *When taken as directed. See Drug Facts Panel.

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    5095192/R812

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

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-527
    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:36800-527-6910 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07715308/31/2007
    Labeler - Topcare Associates LLC (006935977)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029manufacture(36800-527)
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

More Info on this Drug

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