Label: LORATADINE tablet

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

Drug Label Information

Updated June 20, 2012

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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
  • How supplied

    They are supplied by State of Florida DOH Central Pharmacy as follows:

    NDCStrengthQuantity/FormColorSource Prod. Code
    54868-5268-010 mg30 Tablets in a Blister PackWHITE45802-0650
  • 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 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

    • Safety sealed: do not use if the imprinted bottle seal is open or torn.

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

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

  • Questions or comments?

    1 800 719-9260

    This product is manufactured by:

    Perrigo Company
    515 Eastern Avenue Allegan
    Michigan 49010


    This Product was Relabeled with "Additional" barcode label By:

    Physicians Total Care, Inc.
    Tulsa, OK        74146

  • 10 mg Label

    NDC 54868-5268-0 Non-Drowsy*

    image of 10 mg OTC package label

    LORAtadineTablets, USP

    10 mg

    Antihistamine

    Indoor & Outdoor Allergies

    24 Hour

    Relief of:

    • Sneezing

    • Runny Nose

    • Itchy, Watery

    Eyes

    • Itchy Throat

    or Nose

    * When taken as directed.

    See Drug Facts Panel.

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5268(NDC:45802-650)
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize6mm
    FlavorImprint Code L612
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-5268-01 in 1 CARTON
    130 in 1 BLISTER PACK
    2NDC:54868-5268-160 in 1 BOTTLE
    3NDC:54868-5268-290 in 1 BOTTLE
    4NDC:54868-5268-3100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07630104/18/2005
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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