Label: LORATADINE ANTIHISTAMINE- loratadine tablet

  • NDC Code(s): 45802-650-65, 45802-650-78, 45802-650-87
  • Packager: Perrigo New York Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 28, 2019

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

  • Active ingredient (in each tablet)

    Loratadine 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

    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 printed foil under cap is broken or missing
    store between 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to Claritin® active ingredient

    Loratadine Tablets, 10 mg

    Antihistamine

    24 Hour Relief of:

    Sneezing

    Runny Nose

    Itchy, Watery Eyes

    Itchy Throat or Nose

    Original Prescription Strength

    Non-Drowsy*

    *When taken as directed. See Drug Facts Panel.

    actual size

    30 TABLETS

    Indoor & Outdoor Allergies

    Perrigo Loratadine Tablets
  • INGREDIENTS AND APPEARANCE
    LORATADINE  ANTIHISTAMINE
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-650
    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)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize8mm
    FlavorImprint Code L612
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45802-650-651 in 1 CARTON10/15/2008
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:45802-650-781 in 1 CARTON10/07/2009
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:45802-650-871 in 1 CARTON10/28/2008
    3300 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07630110/15/2008
    Labeler - Perrigo New York Inc (078846912)