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Claritin-D 24 Hour: Package Insert / Prescribing Info

Package insert / product label
Generic name: loratadine and pseudoephedrine sulfate
Dosage form: tablet, extended release
Drug class: Upper respiratory combinations

Medically reviewed by Drugs.com. Last updated on Dec 12, 2024.

Drug Facts

Active ingredient (in each tablet)Purpose
Loratadine 10 mgAntihistamine
Pseudoephedrine sulfate 240 mgNasal decongestant

Indications and Usage for Claritin-D 24 Hour

  • 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.

Claritin-D 24 Hour Dosage and Administration

  • 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

Storage and Handling

  • 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

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton

NDC 11523-4332-1

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

Carton label frontCarton label back

CLARITIN-D 24 HOUR
loratadine and pseudoephedrine sulfate tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4332
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 (1600000 WAMW) (UNII: RFW2ET671P)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeROUNDSize18mm
FlavorImprint CodeClaritin;D;24
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-4332-11 in 1 CARTON12/01/2009
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:11523-4332-21 in 1 CARTON12/01/2009
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:11523-4332-33 in 1 CARTON12/01/2009
35 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02047012/01/2009
Labeler - Bayer HealthCare LLC. (112117283)