Label: ALLERGY RELIEF- loratadine tablet

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

Drug Label Information

Updated October 20, 2022

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  • Active ingredient (in each tablet)

    Loratadine, USP 10 mg

  • 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 20° to 25°C (68° to 77°F)
    • protect from light
  • Inactive ingredients

    lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

    Questions?

    call 1-800-540-3765

  • HOW SUPPLIED

    Product: 50090-6164

    NDC: 50090-6164-4 30 TABLET in a BOTTLE

    NDC: 50090-6164-5 90 TABLET in a BOTTLE

    NDC: 50090-6164-0 10 TABLET in a BOTTLE

  • loratadine

    Label Image
  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-6164(NDC:57896-658)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 439
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-6164-010 in 1 BOTTLE; Type 0: Not a Combination Product10/12/2022
    2NDC:50090-6164-430 in 1 BOTTLE; Type 0: Not a Combination Product10/12/2022
    3NDC:50090-6164-590 in 1 BOTTLE; Type 0: Not a Combination Product10/12/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07520902/01/2020
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-6164) , REPACK(50090-6164)
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