NDC 11523-4332 Claritin-d 24 Hour
Loratadine And Pseudoephedrine Sulfate Tablet, Extended Release Oral

Product Information

Product Code11523-4332
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Claritin-d 24 Hour
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Loratadine And Pseudoephedrine Sulfate
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormTablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Bayer Healthcare Llc.
Labeler Code11523
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
NDA020470
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
12-01-2009
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Characteristics

Color(s)WHITE (C48325 - WHITE TO OFF-WHITE)
ShapeROUND (C48348)
Size(s)18 MM
Imprint(s)CLARITIN;D;24
Score1

Product Packages

NDC 11523-4332-1

Package Description: 1 BLISTER PACK in 1 CARTON > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Price per Unit: $1.05364 per EA

NDC 11523-4332-2

Package Description: 1 BLISTER PACK in 1 CARTON > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Price per Unit: $1.05364 per EA

NDC 11523-4332-3

Package Description: 3 BLISTER PACK in 1 CARTON > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Price per Unit: $1.05364 per EA

Product Details

Claritin-d 24 Hour is a human over the counter drug product labeled by Bayer Healthcare Llc.. The generic name of Claritin-d 24 Hour is loratadine and pseudoephedrine sulfate. The product's dosage form is tablet, extended release and is administered via oral form.


What are Claritin-d 24 Hour Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:


Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
  • HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POVIDONES (UNII: FZ989GH94E)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SUCROSE (UNII: C151H8M554)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)


Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.


* Please review the disclaimer below.

Patient Education

Loratadine

Loratadine is pronounced as (lor at' a deen)

Why is loratadine medication prescribed?
Loratadine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include ...
[Read More]
Pseudoephedrine

Pseudoephedrine is pronounced as (soo doe e fed' rin)
Why is pseudoephedrine medication prescribed?
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseud...
[Read More]

* Please review the disclaimer below.

Claritin-d 24 Hour Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Drug Facts


Otc - Purpose



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

Otc - Do Not Use



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.

Otc - Ask Doctor



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.

Otc - When Using



When using this product do not take more than directed. Taking more than directed may cause drowsiness.


Otc - Stop Use



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

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



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


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


* Please review the disclaimer below.