Label: LORATADINE tablet

  • NDC Code(s): 63868-151-01, 63868-151-10, 63868-151-30
  • Packager: Chain Drug Marketing Association Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 27, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 (1-800-222-1222).

  • 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 or kidney diseaseask a doctor
  • Other information

    • store between 20° to 25° C (68° to 77° F)
    • protect from excessive moisture
    • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • Inactive ingredients

    corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

  • Questions?

    call 1-800-406-7984

  • SPL UNCLASSIFIED SECTION

    Distributed by C.D.M.A., Inc.©
    43157 W. Nine Mile
    Novi, MI 48376-0995

  • PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

    QUALITY
    CHOICE

    NDC 63868-151-30

    †Compare to
    Active Ingredient in
    CLARITIN®

    Original Prescription Strength

    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 | Non-Drowsy*

    30 Tablets

    *When taken as directed. See Drug Facts Panel.

    Principal Display Panel - 30 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-151
    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:63868-151-1010 in 1 BLISTER PACK; Type 0: Not a Combination Product08/19/2003
    2NDC:63868-151-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product08/19/2003
    3NDC:63868-151-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/19/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07613408/19/2003
    Labeler - Chain Drug Marketing Association Inc. (011920774)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.051565745manufacture(63868-151)
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