CLARITIN-D 24 HOUR- loratadine and pseudoephedrine sulfate tablet, extended release 
Bayer HealthCare LLC.

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Claritin-D ®

24 Hour

Drug Facts

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

  • each tablet contains: calcium 25 mg
  • safety sealed: do not use if the individual blister unit imprinted with Claritin-D ® 24 hour is open or torn
  • store between 20° to 25°C (68° to 77°F)
  • protect from light and store in a dry place

Inactive ingredients

carnauba wax, dibasic calcium phosphate dihydrate, ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, pharmaceutical ink, polyethylene glycol, povidone, silicon dioxide, sucrose, titanium dioxide, white wax

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 10 Tablet Carton

NDC 11523-7161-2

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.

10
EXTENDED
RELEASE TABLETS

Principal Display Panel - 10 Tablet Carton
CLARITIN-D  24 HOUR
loratadine and pseudoephedrine sulfate tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7161
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCROSE (UNII: C151H8M554)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WHITE WAX (UNII: 7G1J5DA97F)  
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeROUNDSize18mm
FlavorImprint Code Claritin;D;24
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-7161-11 in 1 CARTON12/01/200907/30/2016
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:11523-7161-21 in 1 CARTON12/01/200907/30/2016
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:11523-7161-33 in 1 CARTON12/01/200907/30/2016
35 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02047012/01/200907/30/2016
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 7/2017
 
Bayer HealthCare LLC.