Label: COUNTERACT ALLERGY- loratadine tablet

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

Drug Label Information

Updated August 18, 2023

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  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)
    Loratadine 10 mg

  • PURPOSE

    Purpose
    Antihistamine

  • INDICATIONS & USAGE

    Use 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

    Warnings

  • DO NOT USE

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients

  • ASK DOCTOR

    Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

  • WHEN USING

    When using this product do not take more than directed. Taking more than directed may cause drowsiness.

  • STOP USE

    Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health processional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    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








  • STORAGE AND HANDLING

    Other information

    • store at 20°-25°C (68°-77°F)
    • protect from excessive moisture
  • INACTIVE INGREDIENT

    Inactive ingredients  lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

  • QUESTIONS

    Questions or comments? 1-800-282-3000

  • PRINCIPAL DISPLAY PANEL

    Counteract Allergy LabelCounteract Allergy Box

  • INGREDIENTS AND APPEARANCE
    COUNTERACT  ALLERGY
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-166
    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)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (White colored) Scoreno score
    ShapeOVAL (Oval shaped) Size8mm
    FlavorImprint Code L612
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-166-313 in 1 BOX08/19/2023
    110 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07520908/19/2023
    Labeler - Melaleuca, Inc. (139760102)
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