Label: LORATADINE ANTIHISTAMINE- loratadine tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated February 8, 2022

If you are a healthcare professional or from the pharmaceutical industry 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

  • HOW SUPPLIED

    NDC: 63629-1329-1: 20 Tablets in a BOTTLE

    NDC: 63629-1329-2: 30 Tablets in a BOTTLE

    NDC: 63629-1329-3: 60 Tablets in a BOTTLE

    NDC: 63629-1329-4: 14 Tablets in a BOTTLE

    NDC: 63629-1329-5: 10 Tablets in a BOTTLE

    NDC: 63629-1329-6: 90 Tablets in a BOTTLE

    NDC: 63629-1329-7: 28 Tablets in a BOTTLE

    NDC: 63629-1329-8: 15 Tablets in a BOTTLE

    NDC: 63629-1329-9: 100 Tablets in a BOTTLE

  • PRINCIPAL DISPLAY PANEL

    Loratadine 10mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    LORATADINE  ANTIHISTAMINE
    loratadine tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63629-1329(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, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize8mm
    FlavorImprint Code L612
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63629-1329-120 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2022
    2NDC:63629-1329-230 in 1 BOTTLE; Type 0: Not a Combination Product01/16/2009
    3NDC:63629-1329-360 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2022
    4NDC:63629-1329-414 in 1 BOTTLE; Type 0: Not a Combination Product12/04/2008
    5NDC:63629-1329-510 in 1 BOTTLE; Type 0: Not a Combination Product06/25/2010
    6NDC:63629-1329-690 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2012
    7NDC:63629-1329-728 in 1 BOTTLE; Type 0: Not a Combination Product04/25/2011
    8NDC:63629-1329-815 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2022
    9NDC:63629-1329-9100 in 1 BOTTLE; Type 0: Not a Combination Product12/17/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07630110/15/2008
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(63629-1329) , RELABEL(63629-1329)