Label: LORATADINE tablet

  • NDC Code(s): 51079-246-01, 51079-246-20
  • Packager: Mylan Institutional Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 11, 2023

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  •    

    Original Prescription Strength Non-Drowsy*

    Indoor and Outdoor Allergies

    *When taken as directed. See Drug Facts Panel.

    TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

  • 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.

  • Directions (24 Hour Relief)

    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

    • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
    • Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
    • protect from excessive moisture
  • Inactive Ingredients

    Corn starch, lactose monohydrate and magnesium stearate.

  • Questions or comments?

    1-800-848-0462

    • Serious side effects associated with use of this product may be reported to this number.

    Manufactured for:
    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    Made in India

    Code No.: MH/DRUGS/25/NKD/89

    Distributed by:
    Mylan Institutional Inc.
    Rockford, IL 61103 U.S.A.

    S-11333 R2
    11/16

  •      

    PRINCIPAL DISPLAY PANEL – 10 mg

    NDC 51079-246-20

    Loratadine
    Tablets, USP
    10 mg

    Antihistamine

    Original Prescription Strength    Non-Drowsy*

    Indoor and Outdoor Allergies

    24 Hour Relief (See Uses section of enclosed leaflet)

    *When taken as directed. See enclosed leaflet.

    TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE
    TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

    Loratadine Tablets, USP 10 mg Carton Label
    Outer Carton Label
  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51079-246
    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 G;L;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51079-246-20100 in 1 BOX, UNIT-DOSE04/30/201308/31/2024
    1NDC:51079-246-011 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07615404/30/201308/31/2024
    Labeler - Mylan Institutional Inc. (039615992)
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