Label: HELP I HAVE ALLERGIES- loratadine tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 6, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient                                 Purpose
    (in each tablet)

    Loratadine 10mg..........................................Antihistamine

  • PURPOSE

    Use

    Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies
    • runny nose
    • itchy, watery eyes
    • itching of the nose or throat
    • sneezing


  • WARNINGS


    Warnings

    Do not use ifyou 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.
  • 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.

  • PREGNANCY OR BREAST FEEDING


    If pregnant or breast feeding,     ask a health professional before use.
  • 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
  • INDICATIONS & USAGE

    Other Information

    • do not use if individual blister is open or torn
    • store between 20-25 degrees celcius (68-77 degrees fahrenheits)
    • protect from excessive moisture
    • use by expiration date on package
    • keep carton. They contain important information.
  • INACTIVE INGREDIENT


    Inactive Ingredients

    corn starch, lactose monohydrate, magnesium stearate,pregelatinized starch
  • QUESTIONS

    Distributed by Help Remedies,
    57 W. 28th St. Fl. 4
    New York, NY 10001
    www.helpineedhelp.com

  • PRINCIPAL DISPLAY PANEL

    HelpAllergiesLabel

  • INGREDIENTS AND APPEARANCE
    HELP I HAVE ALLERGIES 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49260-611
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN) Loratadine10 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (round) Size7mm
    FlavorImprint Code RX526
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49260-611-2424 in 1 BOTTLE
    2NDC:49260-611-088 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2009
    Labeler - Help Remedies, Inc. (050359682)
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