Label: CLARITIN- loratadine tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 9, 2022

If you are a healthcare professional or from the pharmaceutical industry 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 (Blister foil units)

    • 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
  • Other information (Bottles)

    • Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
    • store between 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    corn starch, lactose monohydrate, magnesium stearate

  • Questions or comments?

    Repackaged and Distributed By:

    Remedy Repack, Inc.

    625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

  • PRINCIPAL DISPLAY PANEL

    DRUG: Claritin

    GENERIC: Loratadine

    DOSAGE: TABLET

    ADMINSTRATION: ORAL

    NDC: 70518-2951-0

    COLOR: white

    SHAPE: ROUND

    SCORE: No score

    SIZE: 6 mm

    IMPRINT: 458;Claritin10

    PACKAGING: 10 in 1 BLISTER PACK

    OUTER PACKAGING: 1 in 1 CARTON

    ACTIVE INGREDIENT(S):

    • LORATADINE 10mg in 1

    INACTIVE INGREDIENT(S):

    • STARCH, CORN
    • MAGNESIUM STEARATE
    • LACTOSE MONOHYDRATE

    Remedy_Label

  • INGREDIENTS AND APPEARANCE
    CLARITIN 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-2951(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:70518-2951-01 in 1 CARTON12/01/2020
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01965812/01/2020
    Labeler - REMEDYREPACK INC. (829572556)