CLARITIN-D 24 HOUR- loratadine 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

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 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

Inactive ingredients

black iron oxide, candelilla wax powder, Inactive ingredients colloidal silicon dioxide, glyceryl monostearate, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, propylene glycol, sodium lauryl sulfate, talc, titanium dioxide

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton

FC008192_CLARITIN-D_CLARITIN-D24_Tablets

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.

5

EXTENDED

RELEASE TABLETS

CLARITIN-D  24 HOUR
loratadine pseudoephedrine sulfate tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0102
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
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
TALC (UNII: 7SEV7J4R1U)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CANDELILLA WAX (UNII: WL0328HX19)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeOVALSize18mm
FlavorImprint Code Andrx;605
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-0102-11 in 1 CARTON12/12/2022
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:11523-0102-21 in 1 CARTON12/12/2022
215 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07570612/12/2022
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 11/2023
Document Id: 0b61ba97-5340-90f2-e063-6394a90a4801
Set id: 3ea6a90b-8cb1-46b0-9ff7-be7090245e53
Version: 8
Effective Time: 20231130
 
Bayer HealthCare LLC.