CLARITIN-D  12 HOUR- loratadine and pseudoephedrine sulfate tablet, extended release 
MSD Consumer Care, Inc.

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Claritin-D®
12 Hour

Drug Facts

Active ingredient (in each tablet) Purpose
Loratadine 5 mg Antihistamine
Pseudoephedrine sulfate 120 mg Nasal 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 over 1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years of age ask a doctor
consumers with liver or kidney disease ask 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

© Copyright & Distributed by MSD Consumer Care, Inc., PO Box 377,
Memphis, TN 38151 USA, a subsidiary of Merck & Co., Inc.,
Whitehouse Station, NJ USA.

PRINCIPAL DISPLAY PANEL - Blister Pack 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

Principal Display Panel - Blister Pack Carton
CLARITIN-D   12 HOUR
loratadine and pseudoephedrine sulfate tablet, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-7162
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN) Loratadine 5 mg
pseudoephedrine sulfate (UNII: Y9DL7QPE6B) (pseudoephedrine - UNII:7CUC9DDI9F) pseudoephedrine sulfate 120 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium (UNII: M28OL1HH48)  
calcium phosphate, dibasic, anhydrous (UNII: L11K75P92J)  
hypromelloses (UNII: 3NXW29V3WO)  
lactose monohydrate (UNII: EWQ57Q8I5X)  
magnesium stearate (UNII: 70097M6I30)  
povidones (UNII: FZ989GH94E)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL Size 12mm
Flavor Imprint Code Claritin;D;12
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11523-7162-1 1 in 1 CARTON
1 10 in 1 BLISTER PACK
2 NDC:11523-7162-2 2 in 1 CARTON
2 10 in 1 BLISTER PACK
3 NDC:11523-7162-3 3 in 1 CARTON
3 10 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019670 12/01/2009
Labeler - MSD Consumer Care, Inc. (968091715)

Revised: 9/2012
Document Id: da383402-da73-419d-b68d-930b1f2b50bf
Set id: a7125705-01ff-4418-8c53-9209c2bbb484
Version: 2
Effective Time: 20120904
 
MSD Consumer Care, Inc.