Label: LORATADINE tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 19, 2017

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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 or kidney disease

    ask a doctor
  • Other Information

    • Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only).
    • Safety sealed: do not use if open or torn (for blister package only).

    • Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).
  • Inactive Ingredients

    Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

  • Questions or comments?

    1-800-525-8747

    10-2015M

    Sandoz Inc.

    Princeton, NJ 08540

  • 10 mg Label

    Loratadine 10 mg Label

    NDC 67046-453-30 Non-Drowsy*

    Loratadine

    Tablets, USP

    10 mg

    Antihistamine

    Indoor & Outdoor Allergies

    30 Tablets

    SANDOZ

    24 Hour

    Relief of:

    Sneezing

    Runny Nose

    Itchy, Watery

    Eyes

    Itchy Throat

    or Nose

    * When taken as directed.

    See Drug Facts Panel.

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-453(NDC:0781-5077)
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Colorwhite (white to off white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code GG296
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67046-453-077 in 1 BLISTER PACK; Type 0: Not a Combination Product09/19/2017
    2NDC:67046-453-1414 in 1 BLISTER PACK; Type 0: Not a Combination Product09/19/2017
    3NDC:67046-453-1515 in 1 BLISTER PACK; Type 0: Not a Combination Product09/19/2017
    4NDC:67046-453-2121 in 1 BLISTER PACK; Type 0: Not a Combination Product09/19/2017
    5NDC:67046-453-2828 in 1 BLISTER PACK; Type 0: Not a Combination Product09/19/2017
    6NDC:67046-453-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product09/19/2017
    7NDC:67046-453-6060 in 1 BLISTER PACK; Type 0: Not a Combination Product09/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07520909/19/2017
    Labeler - Contract Pharmacy Services-PA (945429777)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coupler Enterprises945429777repack(67046-453)
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