Label: LORATADINE ALLERGY RELIEF- loratadine tablet

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

Drug Label Information

Updated January 9, 2018

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  • ACTIVE INGREDIENT(S)

    Loratadine USP, 10 mg

  • PURPOSE

    Antihistamine

  • USE(S)

    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 over1 tablet daily; not more than 1 tablet in 24 hours
    children under 6 years of ageask a doctor
    consumers with liver and kidney diseaseask a doctor
  • OTHER INFORMATION

    • store between 20 and 25° C (68 and 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

  • Questions or Comments?

    1-877-753-3935

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    Lidl US, LLC
    3500 S. Clark Street
    Arlington, VA 22202

  • PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton

    NON-DROWSY* NDC 71141-132-32

    Original Prescription Strength

    †Compare to the active
    ingredient in Claritin®

    Actual Size

    Loratadine
    Tablets,
    USP 10 mg

    Antihistamine

    ALLERGY RELIEF

    24 Hour
    Relief of:

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

    10 tablets

    INDOOR &
    OUTDOOR ALLERGIES
    *When taken as directed. See Drugs Facts Panel.

    PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    LORATADINE ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71141-132
    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:71141-132-321 in 1 CARTON09/01/2017
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07613409/01/2017
    Labeler - LIDL US, LLC (079389709)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029manufacture(71141-132)
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