Label: LORATADINE tablet, orally disintegrating

  • NDC Code(s): 24385-161-52, 24385-540-53
  • Packager: Good Neighbor Pharmacy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 31, 2012

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

  • ACTIVE INGREDIENT (IN EACH TABLET)

    Loratadine USP, 10 mg

  • PURPOSE

    Antihistamine

  • USES

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

  • DIRECTIONS

    • place 1 tablet on tongue; tablet disintegrates, with or without water
      adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours
      children under 6 years of ageask a doctor
      consumers with liver or kidney diseaseask a doctor
  • OTHER INFORMATION

    • Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
    • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
    • store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
    • keep in a dry place.
    • use tablet immediately after opening individual blister.
  • INACTIVE INGREDIENTS

    Aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate

  • QUESTIONS?

    Call 1-800-406-7984

  • PRINCIPAL DISPLAY PANEL

    GOOD NEIGHBOR PHARMACY®

    Compare to active ingredient in Alavert***

    NDC 24385-0540-53

    Non-Drowsy*

    Allergy Relief

    loratadine orally disintegrating tablets, 10 mg

    antihistamine

    no water needed

    melts in your mouth

    Indoor & Outdoor Allergies

    For Adults and Children six years and older!

    For 24 Hour Relief of:

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itching of Nose & Throat

    12 orally disintegrating tablets

    *When taken as directed. See Drug Facts Panel.

    Distributed By: AmerisourceBergen

    5087125/R0611

    This is the blister carton label for 12 count Loratadine ODT for Good Neighbor Pharmacy.

    GOOD NEIGHBOR PHARMACY®

    Compare to active ingredient in Claritin®Reditabs®**

    NDC 24385-0161-52

    Non-Drowsy*

    24 HOUR

    Allergy Relief

    loratadine orally disintegrating tablets, 10 mg

    antihistamine

    • no water needed
    • melts in your mouth

    Indoor & Outdoor Allergies

    Relief of:

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Throat or Nose

    For Kids 6 yrs and older!

    10 orally disintegrating tablets

    *When taken as directed.

    See Drug Facts Panel.

    Distributed By: AmerisourceBergen

    5087123/R0611

    This is the 10 count blister carton label for Good Neighbor Pharmacy Loratadine ODT, 10 mg (Claritin like - for kids).

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-540
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    Product Characteristics
    Colorwhite (White to Off-White) Scoreno score
    ShapeROUND (Flat Faced Beveled Edge) Size10mm
    FlavorFRUITImprint Code RC17
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24385-540-5312 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07715308/31/2007
    LORATADINE 
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-161
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    Product Characteristics
    Colorwhite (White to Off-White) Scoreno score
    ShapeROUND (Flat Faced Beveled Edge) Size10mm
    FlavorFRUITImprint Code RC17
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24385-161-5210 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07715308/31/2007
    Labeler - Good Neighbor Pharmacy (007914906)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029manufacture(24385-540)