Label: LORATADINE tablet, orally disintegrating

  • NDC Code(s): 41163-528-31, 41163-528-69
  • Packager: Supervalu Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 4, 2013

If you are a consumer or patient 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 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 1-877-932-7948

  • PRINCIPAL DISPLAY PANEL

    equaline®

    compare to Claritin®RediTabs®active ingredient**

    NDC 41163-528-69

    original prescription strength

    melts in your mouth

    allergy relief

    loratadine orally disintegrating tablets, USP 10 mg

    antihistamine

    no water needed

    indoor and outdoor allergies

    non-drowsy* 24 hour relief of:

    • runny nose
    • itchy, watery eyes
    • sneezing
    • itchy throat or nose

    10 orally disintegrating tablets

    *When taken as directed. See Drug Facts Panel.

    DISTRIBUTED BY SUPERVALU INC.

    5105058/ R0913

    equalinelabel
  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-528
    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 face, beveled edged) Size10mm
    FlavorSTRAWBERRY, TUTTI FRUTTI, MINTImprint Code RC17
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-528-691 in 1 CARTON
    110 in 1 BLISTER PACK
    2NDC:41163-528-313 in 1 CARTON
    210 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07715312/03/2013
    Labeler - Supervalu Inc. (006961411)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.051565745manufacture(41163-528)