Label: CLARITIN-D 24 HOUR- loratadine pseudoephedrine sulfate tablet, extended release

  • NDC Code(s): 11523-0102-1, 11523-0102-2
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)Purpose
    Loratadine 10 mgAntihistamine
    Pseudoephedrine sulfate 240 mgNasal decongestant
  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • sneezing
    • itchy, watery eyes
    • runny nose
    • itching of the nose or throat
    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • reduces swelling of nasal passages
    • temporarily relieves sinus congestion and pressure
    • temporarily restores freer breathing through the nose
  • Warnings

    Do not use

    • if you have ever had an allergic reaction to this product or any of its ingredients
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • heart disease
    • thyroid disease
    • high blood pressure
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • 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.
    • symptoms do not improve within 7 days or are accompanied by a fever
    • nervousness, dizziness or sleeplessness occurs

    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

    • do not divide, crush, chew or dissolve the tablet
    adults and children 12 years and over1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours
    children under 12 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 light and store in a dry place
  • Inactive ingredients

    black iron oxide, candelilla wax powder, Inactive ingredients colloidal silicon dioxide, glyceryl monostearate, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, propylene glycol, sodium lauryl sulfate, talc, titanium dioxide

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton

    FC008192_CLARITIN-D_CLARITIN-D24_Tablets

    Non-Drowsy*

    Claritin-D     ®

    pseudoephedrine sulfate 240 mg/nasal decongestant

    loratadine 10 mg/antihistamine

    Indoor & Outdoor Allergies

    Allergy & Congestion

    24

    Hour

    Relief of:

    Nasal & Sinus Congestion

    Due to Colds or Allergies

    Sneezing; Runny Nose;

    Itchy, Watery Eyes;

    Itchy Throat or Nose

    Due to Allergies

    * When taken as directed. See Drug Facts Panel.

    5

    EXTENDED

    RELEASE TABLETS

  • INGREDIENTS AND APPEARANCE
    CLARITIN-D  24 HOUR
    loratadine pseudoephedrine sulfate tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE240 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    TALC (UNII: 7SEV7J4R1U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeOVALSize18mm
    FlavorImprint Code Andrx;605
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0102-11 in 1 CARTON12/12/2022
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11523-0102-21 in 1 CARTON12/12/2022
    215 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07570612/12/2022
    Labeler - Bayer HealthCare LLC. (112117283)
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