NDC 11523-4332 Claritin-d 24 Hour

Loratadine And Pseudoephedrine Sulfate

NDC Product Code 11523-4332

NDC CODE: 11523-4332

Proprietary Name: Claritin-d 24 Hour 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.

Non-Proprietary Name: Loratadine And Pseudoephedrine Sulfate 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.

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
Shape: ROUND (C48348)
Size(s):
18 MM
Imprint(s):
CLARITIN;D;24
Score: 1

NDC Code Structure

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

NDC Product Information

Claritin-d 24 Hour with NDC 11523-4332 is a 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. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1117562 and 1242391.

Dosage Form: Tablet, 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.

Product Type: Human Otc Drug 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.

Claritin-d 24 Hour Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the 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)

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.

Labeler Name: Bayer Healthcare Llc.
Labeler Code: 11523
FDA Application Number: NDA020470 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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. 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.

Start Marketing Date: 12-01-2009 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 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.

Exclude Flag: N - NO 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".

* Please review the disclaimer below.

Information for Patients

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 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Otc - Purpose

Active ingredient (in each tablet)PurposeLoratadine 10 mgAntihistaminePseudoephedrine sulfate 240 mgNasal decongestant

Uses

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • Sneezingitchy, watery eyesrunny noseitching of the nose or throattemporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergiesreduces swelling of nasal passagestemporarily relieves sinus congestion and pressuretemporarily restores freer breathing through the nose

Otc - Do Not Use

  • Do not useif you have ever had an allergic reaction to this product or any of its ingredientsif 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 haveheart diseasethyroid diseasehigh blood pressurediabetestrouble urinating due to an enlarged prostate glandliver 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 ifan allergic reaction to this product occurs. Seek medical help right away.symptoms do not improve within 7 days or are accompanied by a fevernervousness, 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 tabletadults and children 12 years and over1 tablet daily with a full glass of water; not more than 1 tablet in 24 hourschildren under 12 years of ageask a doctorconsumers 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

* Please review the disclaimer below.