Label: LORATADINE ALLERGY RELIEF- loratadine tablet

  • NDC Code(s): 10135-763-03, 10135-763-30, 10135-763-90
  • Packager: Marlex Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 9, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 useif you have ever had an allergic reaction to this product or any of its ingredients.

    Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

    When using this productdo not take more than directed. Taking more than directed may cause drowsiness.

    Stop use and ask a doctor ifan 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 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

    • store between 20° to 25° C (68° to 77° F)
    • protect from excessive moisture
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
  • Inactive ingredients

    corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

  • SPL UNCLASSIFIED SECTION

    Manufactured for/ Distributed by:

    Marlex Pharmaceuticals, Inc.

    New Castle, DE 19720

    Rev. 10/22 SP

  • PRINCIPAL DISPLAY PANEL

    Loratadine 10mg Tablets

    NDC 10135-0763-30

    30 Tablets

    label1

    Loratadine 10mg Tablets

    NDC 10135-0763-90

    90 Tablets

    763-90

    Loratadine 10mg Tablets

    NDC 10135-0763-03

    300 Tablets

    label3

  • INGREDIENTS AND APPEARANCE
    LORATADINE ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-763
    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)  
    Product Characteristics
    Colorwhite (White to Off White) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code RX526
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10135-763-3030 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2022
    2NDC:10135-763-9090 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2022
    3NDC:10135-763-03300 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07613410/01/2022
    Labeler - Marlex Pharmaceuticals, Inc. (782540215)
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