Label: LORATADINE ODT- loratadine tablet, orally disintegrating

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

Drug Label Information

Updated October 8, 2015

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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 (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, 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

    CHAIN DRUG CONSORTIUM

    3301 NW BOCA RATON BLVD

    SUITE 101, BOCA RATON, FL 33431

  • PRINCIPAL DISPLAY PANEL

    Premier Value®

    NDC 68016-527-31

    Original Prescription Strength

    NON-DROWSY*

    24 Hour Allergy Relief

    Loratadine Orally Disintegrating Tablets, 10 mg

    Allergy Relief

    Antihistamine

    Indoor & Outdoor Allergies

    No water needed. Melts in your mouth.

    Relief of:

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

    For Adults and Children six years and older!

    30 ORALLY DISINTEGRATING TABLETS

    COMPARE TO THE ACTIVE INGREDIENT OF CLARITIN®REDITABS®†

    *When taken as directed. See Drug Facts Panel.

    †This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc. CLARITIN® and REDITABS® are registered trademarks of Schering Corporation.

    This is the 30 count blister carton label for Premier Value Loratadine ODT, USP 10 mg.
  • INGREDIENTS AND APPEARANCE
    LORATADINE ODT 
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-527
    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:68016-527-3130 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07715308/31/2007
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.051565745MANUFACTURE(68016-527)
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