CLARITIN-D 12 HOUR- loratadine and pseudoephedrine sulfate tablet, extended release 
Bayer HealthCare LLC.

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Claritin-D ®

12 Hour

Drug Facts

Active ingredient (in each tablet)Purpose
Loratadine 5 mgAntihistamine
Pseudoephedrine sulfate 120 mgNasal decongestant

Uses

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

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

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

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)

Revised: 11/2023
Document Id: 0b61c541-d061-9abf-e063-6294a90a7574
Set id: a7125705-01ff-4418-8c53-9209c2bbb484
Version: 8
Effective Time: 20231130
 
Bayer HealthCare LLC.