Label: LORATADINE tablet

  • NDC Code(s): 63548-0753-0, 63548-0753-1, 63548-0753-3
  • Packager: PLD Acquisitions LLC DBA Avéma Pharma Solutions
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 4, 2023

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  • 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
    • sneezing
    • itchy, watery eyes
    • 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.

  • 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

    • safety sealed: do not use if the printed bottle seal is open or torn
    • store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature)
  • Inactive ingredients

    lactose monohydrate,magnesium stearate, microcrystalline cellulose, sodium starch glycolate

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9 AM-5 PM EST

  • Principal Display Panel

    †Compare to the active ingredient in Claritin®

    Loratadine tablets, USP

    Antihistamine

    10 mg

    Non-drowsy*

    Indoor & outdoor allergies

    24-hour relief of

    • sneezing
    • itchy, watery eyes
    • runny nose
    • itchy throat or nose

    100 Tablets

    *When taken as directed. See Drug Facts panel

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    †This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Claritin®

    Manufactured by:

    Avema Pharm Solutions

    10400 NW 29th Terrace, Miami, FL 33172

  • Package Label

    loratadine 10 mg

    Loratadine 10 mg Tablets

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0753
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code GG296
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63548-0753-330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/30/2018
    2NDC:63548-0753-1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/30/2018
    3NDC:63548-0753-0300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07520910/30/2018
    Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)
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