Label: ALLERGY RELIEF- loratadine tablet

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

Drug Label Information

Updated February 16, 2021

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  • Active ingredient (in each tablet)

    Loratadine 10mg

  • Purpose

    Antihistamine

  • Uses

    • temporarily relieves these symptoms due to hay fever and other upper respiratory allergies:

                    -runny nose

                    -sneezing               

                    -itching of the nose and throat

                    -itchy, watery eyes

  • 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
    12 years and over
    		1 tablet daily; not more
    than 1 tablet in 24 hours
    children under 12
    years of age
    		ask a doctor
    consumers with liver
    or kidney disease
    		ask a doctor
  • Other information

    • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken
    • store between 2˚C and 30˚C (36˚F-86˚F)
    • product of Canada
    • protect from excessive moisture
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate,

    magnesium stearate, microcrystalline cellulose

    Questions?

    call 1-800-540-3765

  • package label

    pdp

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-4318(NDC:57896-788)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize8mm
    FlavorImprint Code LOR;10;APO
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-4318-330 in 1 BOTTLE; Type 0: Not a Combination Product03/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07647101/01/2008
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharamceuticals,Inc.010632300relabel(68071-4318)
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