Label: LORATADINE ALLERGY RELIEF- loratadine tablet

  • NDC Code(s): 53943-975-30, 53943-975-60
  • Packager: DISCOUNT DRUG MART
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 14, 2018

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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

    • 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?

    call 1-800-406-7984

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    DRUG MART-FOOD FAIR
    MEDINA, OHIO 44256

  • PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

    DISCOUNT
    drug
    mart
    FOOD FAIR

    Non-Drowsy†

    Allergy Relief

    Loratadine
    Tablets USP, 10 mg

    Antihistamine
    Indoor & Outdoor Allergies

    RELIEF OF: Sneezing; Runny Nose
    Itchy, Watery Eyes
    Itchy Throat or Nose

    24 Hour Allergy Relief

    60 Tablets

    †When taken as directed. See Drug Facts Panel.

    Principal Display Panel - 10 mg Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    LORATADINE ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-975
    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:53943-975-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product11/01/2017
    2NDC:53943-975-6060 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07613411/01/2017
    Labeler - DISCOUNT DRUG MART (047741335)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029manufacture(53943-975)
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