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Claritin-D 12 Hour

Medically reviewed on July 20, 2017

Dosage form: tablet, extended release
Ingredients: LORATADINE 5mg, PSEUDOEPHEDRINE SULFATE 120mg
Labeler: Bayer HealthCare LLC.
NDC Code: 11523-7162

Claritin-D ®

12 Hour

Drug Facts

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

CLARITIN-D  12 HOUR
loratadine and pseudoephedrine sulfate tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7162
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE5 mg
PSEUDOEPHEDRINE SULFATE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE SULFATE120 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POVIDONES 
TITANIUM DIOXIDE 
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeOVALSize12mm
FlavorImprint CodeClaritin;D;12
Contains    
Packaging
#Item CodePackage Description
1NDC:11523-7162-11 BLISTER PACK in 1 CARTON
110 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
2NDC:11523-7162-22 BLISTER PACK in 1 CARTON
210 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
3NDC:11523-7162-33 BLISTER PACK in 1 CARTON
310 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01967012/01/2009
Labeler - Bayer HealthCare LLC. (112117283)

 
Bayer HealthCare LLC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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