Label: LORATADINE tablet

  • NDC Code(s): 0378-8880-10
  • Packager: Mylan Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 15, 2013

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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
    •
    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

    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 of kidney disease

    ask a doctor
  • Other information

    •
    Tamper Evident: do not use if foil seal under cap is missing, open or broken.
    •
    store between 20° to 25°C (68° to 77°F)
    •
    protect from excessive moisture
  • Inactive ingredients

    Corn starch, lactose monohydrate and magnesium stearate.

  • Questions or comments?

    call 1-877-446-3679 (1-877-4-INFO-RX)

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

    Made in India
    Code No.: MH/DRUGS/25/NKD/89

  • PRINCIPAL DISPLAY PANEL

    PRODUCT PACKAGING

    NDC 0378-8880-10

    Original Prescription Strength

    Non-Drowsy*

    Loratadine
    Tablets USP, 10 mg

    Antihistamine

    Indoor and Outdoor Allergies

    24 Hour Relief of:

    •
    Sneezing
    •
    Runny Nose
    •
    Itchy, Watery Eyes
    •
    Itchy Throat or Nose

    *When taken as directed. See Drug Facts Panel.

    RMX8880C1

    100 Tablets

    Loratadine Tablets 10 mg Bottles Front First Layer
    Loratadine Tablets 10 mg Bottles Back of Front Layer
    Loratadine Tablets 10 mg Bottles Base Layer
  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0378-8880
    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:0378-8880-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07615406/01/2011
    Labeler - Mylan Pharmaceuticals Inc. (059295980)
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