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

Drug Label Information

Updated November 30, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!