Label: CAREALL LORATADINE- loratadine tablet

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

Drug Label Information

Updated February 13, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Loratadine 10mg

  • PURPOSE

    Antihistamine

  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

  • INDICATIONS & USAGE

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

    runny nose, itchy, watery eys, 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.

  • DOSAGE & ADMINISTRATION

    Adult and children over 6 years old: 1 tablets daily: no 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

  • INACTIVE INGREDIENT

    lactose monohydrate, magnesium stearate, sodium starch glycolate.  May contain: microcrystalline cellulose, pregelatinized starch

  • OTHER SAFETY INFORMATION

    Store between 20-25 degrees celcius (68-77 degrees farhenheit).

    Protect from excessive moisture

    Do not use if imprinted seal under bottle cap is broken or missing

    You may report side effects 1-888-952-0050

  • PRINCIPAL DISPLAY PANEL

    Loratadine Label

  • INGREDIENTS AND APPEARANCE
    CAREALL LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-075
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (White to off white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code GG296;G;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-075-0130 in 1 BOTTLE; Type 0: Not a Combination Product03/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21072203/02/2020
    Labeler - New World Imports (075372276)
    Registrant - New World Imports (075372276)