Label: LIL DRUG STORE CLARITIN NON-DROWSY, 24 HOUR- loratadine tablet

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

Drug Label Information

Updated July 13, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Loratadine 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 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

    • safety sealed: do not use if the individual blister unit imprinted with Claritin ® is open or torn
    • store between 20° to 25° C (68° to 77° F)
    • protect from excessive moisture
  • Inactive ingredients

    corn starch, lactose monohydrate, magnesium stearate

  • Questions or comments?

    1-800-CLARITIN (1-800-252-7484) or www.claritin.com

  • SPL UNCLASSIFIED SECTION

    PRODUCT MANUFACTURED BY:
    MSD CONSUMER CARE, INC.,
    P.O. BOX 377, MEMPHIS, TN 38151 USA,
    A SUBSIDIARY OF MERCK & CO., INC.,
    WHITEHOUSE STATION, NJ USA.

  • PRINCIPAL DISPLAY PANEL - 1 Tablet Pouch Carton

    Original Prescription Strength

    Non-Drowsy*
    Claritin®
    loratadine tablets 10 mg/antihistamine

    24
    Hour

    Relief of:

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

    *When taken as directed.
    See Drug Facts Panel.

    Indoor & Outdoor
    Allergies

    1
    Tablet

    Lil'
    Drug Store®

    Principal Display Panel - 1 Tablet Pouch Carton
  • INGREDIENTS AND APPEARANCE
    LIL DRUG STORE CLARITIN   NON-DROWSY, 24 HOUR
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9732(NDC:11523-7160)
    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
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 458;Claritin10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-9732-11 in 1 CARTON03/01/2016
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:66715-9732-22 in 1 CARTON03/01/2016
    21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01965804/21/2011
    Labeler - Lil' Drug Store Products, Inc (093103646)