Label: LORATADINE tablet

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

Drug Label Information

Updated October 4, 2022

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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:

    • itching of the nose or throat
    • runny nose
    • itchy, watery eyes
    • sneezing
  • 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 (1-800-222-1222).

  • 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

    • store between 20° to 25°C (68° to 77°F)
    • protect from excessive moisture
    • FOR YOUR PROTECTION: Do not use if blister is torn or broken.
  • Inactive Ingredients

    Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

  • Questions?

    for Ohm Laboratories call 1-800-406-7984

    The drug product contained in this package is from NDC # 51660-526, Ohm Laboratories Inc.

    Packaged and Distributed by:
    American Health Packaging, Columbus, Ohio 43217

  • Principal Display Panel – Carton – 10 mg

    10 mg Loratadine Tablets Carton

    NDC 68084- 248-01

    NON-DROWSY* 24 Hour Allergy Relief
    Loratadine Tablets, USP

    Antihistamine Indoor & Outdoor Allergies

    10 mg

    100 Tablets (10 x 10)

    * When taken as directed. See Drug Facts Panel.

    The drug product contained in this package is from
    NDC # 51660-526, Ohm Laboratories Inc.

    Packaged and Distributed by:
    American Health Packaging, Columbus, Ohio 43217

    801697
    0224801/0119

  • Principal Display Panel – Blister – 10 mg

    10 mg Loratadine Tablet Blister

    Allergy Relief
    Loratadine
    Tablet, USP   10 mg

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68084-248(NDC:51660-526)
    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:68084-248-01100 in 1 BOX, UNIT-DOSE11/09/2007
    1NDC:68084-248-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07613411/09/2007
    Labeler - American Health Packaging (929561009)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Health Packaging929561009repack(68084-248)
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