Label: ALLERGY RELIEF- loratadine tablet

  • NDC Code(s): 68998-414-82, 68998-414-85
  • Packager: Marc Glassman, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 28, 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 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 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 open
  • 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

  • Principal Display Panel

    Allergy Relief 30

    Allergy Relief 30

    Allergy Relief

    Allergy Relief


  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-414
    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)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containMICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    May containSTARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code G;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68998-414-8530 in 1 CARTON; Type 0: Not a Combination Product05/01/2020
    2NDC:68998-414-8290 in 1 BOTTLE; Type 0: Not a Combination Product08/16/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21072205/01/2020
    Labeler - Marc Glassman, Inc. (094487477)
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