Label: CLARITIN-D 12 HOUR- loratadine and pseudoephedrine sulfate tablet, extended release

  • NDC Code(s): 11523-7162-1, 11523-7162-2, 11523-7162-3
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: 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 5 mgAntihistamine
    Pseudoephedrine sulfate 120 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 every 12 hours; not more than 2 tablets in 24 hours
    children under 12 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor
  • Other information

    • each tablet contains: calcium 30 mg
    • safety sealed: do not use if the individual blister unit imprinted with Claritin-D ® 12 Hour is open or torn
    • store between 20° to 25°C (68° to 77°F)
    • keep in a dry place
  • Inactive ingredients

    croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium sterarate, pharmaceutical ink, povidone, titanium dioxide

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL - Carton

    NDC 11523-7162-1

    Non-Drowsy*

    Claritin-D®

    pseudoephedrine sulfate 120 mg/nasal decongestant

    loratadine 5 mg/antihistamine

    Indoor & Outdoor Allergies

    Allergy & Congestion

    12

    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.

    10

    EXTENDED

    RELEASE TABLETS

    Carton

  • INGREDIENTS AND APPEARANCE
    CLARITIN-D  12 HOUR
    loratadine and pseudoephedrine sulfate tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7162
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg
    PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE120 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code Claritin;D;12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-7162-11 in 1 CARTON12/01/2009
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11523-7162-22 in 1 CARTON12/01/2009
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:11523-7162-33 in 1 CARTON12/01/2009
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01967012/01/2009
    Labeler - Bayer HealthCare LLC. (112117283)
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