Label: LORATADINE tablet

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

Drug Label Information

Updated September 28, 2018

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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.

  • Directions

    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

    •
    Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only).
    •
    Safety sealed: do not use if open or torn (for blister package only).

    •
    Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).
  • Inactive Ingredients

    Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

  • Questions or comments?

    1-800-206-7821

    © 2005 NorthStar Healthcare Holdings     I10-2015M

    Manufactured for: Northstar Rx LLC

    Memphis, TN 38141.

    Manufactured by: Sandoz Inc.

    Princeton, NJ 08540.

  • HOW SUPPLIED

    Product: 50090-3464

    NDC: 50090-3464-0 30 TABLET in a BOTTLE

  • Loratadine

    Label Image
  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-3464(NDC:16714-482)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (white to off white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code GG296
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-3464-030 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07520902/01/2016
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-3464) , REPACK(50090-3464)
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