Label: GUARDIAN LORATADINE- loratadine tablet

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

Drug Label Information

Updated July 22, 2019

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  • ACTIVE INGREDIENT (in each tablet)

    Loratadine USP, 10mg

  • PURPOSE

    Antihistamine

  • USE(S)

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


    • runny nose
    • sneezing
    • itchy, watery eyes
    • 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 DOCTOR IF

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

  • IF PREGNANT OR BREASTFEEDING,

    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 6 years and over1 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

    • Store at 20o to 25oC (68o to 77oF) [See USP Controlled Room Temperature]
    • Protect from excessive moisture


    SAFETY SEALED: DO NOT USE IF THE IMPRINTED BOTTLE SEAL WITH "SEALED FOR YOUR PROTECTION" IS OPEN OR TORN 

  • INACTIVE INGREDIENTS

    colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate

  • QUESTIONS OR COMMENTS?

    call 1-609-860-2600 Hours: 8am-4pm, EST.

  • PRINCIPAL DISPLAY PANEL

    Guardian
    NDC 53041-285-21

    Non-Drowsy*

    Original Prescription Strength

    Loratadine
    Tablets, USP 10 mg

    Antihistamine

    Indoor & Outdoor Allergies

    24 Hour Relief of:
    Sneezing
    Runny Nose
    Itchy, Watery Eyes
    Itchy Throat Or Nose



    285

  • INGREDIENTS AND APPEARANCE
    GUARDIAN LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-285
    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)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code L
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53041-285-211000 in 1 BOTTLE; Type 0: Not a Combination Product07/22/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20756907/22/2019
    Labeler - Guardian Drug Company (119210276)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(53041-285)
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