Label: ALLERGY RELIEF- loratadine 10mg tablet

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

Drug Label Information

Updated November 12, 2020

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  • Active ingredient(s)

    Loratadine 10mg

  • Purpose

    Antihistamine

  • Use(s)

    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

    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

    if an allergic reaction to this product occurs. Seek medical help right away.

    Pregnancy/Breastfeeding

    Keep out of reach of children

    In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) 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

    • do not use if blister unit is torn or
  • Storage

    • store between 20° to 25°C (68° to 77°F)
    • protect from excessive moisture

  • Inactive ingredients

    lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate

  • Questions

    1-800-327-2704 Monday - Friday 8:00am - 5:00pm (CDT)

  • Principal Display Panel

    Allergy Relief Loratadine

    Allergy Relief Loratadine


  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    loratadine 10mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53117-414
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code G;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53117-414-852 in 1 CARTON11/11/2020
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21072211/11/2020
    Labeler - First Aid Direct (962283128)
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