NDC 45802-122 Loratadine D
Loratadine, Pseudoephedrine Sulfate Tablet, Film Coated, Extended Release Oral

Product Information

Product Code45802-122
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.
Loratadine D
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, 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, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
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.
Padagis Israel Pharmaceuticals Ltd
Labeler Code45802
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.
ANDA076050
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.
ANDA - A product marketed under an approved Abbreviated 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.
04-10-2018
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.
12-31-2022
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 - TO OFF-WHITE)
ShapeROUND (C48348)
Size(s)12 MM
Imprint(s)7U0
Score1

Product Packages

NDC 45802-122-46

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

Price per Unit: $0.79901 per EA

NDC 45802-122-60

Package Description: 20 BLISTER PACK in 1 CARTON > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Price per Unit: $0.79901 per EA

NDC 45802-122-65

Package Description: 30 BLISTER PACK in 1 CARTON > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Price per Unit: $0.79901 per EA

Product Details

Loratadine D is a human over the counter drug product labeled by Padagis Israel Pharmaceuticals Ltd. The generic name of Loratadine D is loratadine, pseudoephedrine sulfate. The product's dosage form is tablet, film coated, extended release and is administered via oral form.


What are Loratadine D 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 code indicates a single concept unique identifier (RXCUI) is 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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POVIDONES (UNII: FZ989GH94E)
  • 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.

Loratadine D 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



Active Ingredients (In Each Tablet)



Loratadine 5 mg

Pseudoephedrine sulfate 120 mg


Purpose



Antihistamine

Nasal 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

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 (1-800-222-1222).


Directions



  • •do not divide, crush, chew or dissolve the tablet
  • 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



  • each tablet contains: calcium 25 mg
  • •do not use if blister unit is broken or torn
  • •store between 20° to 25°C (68° to 77°F)
  • •keep in a dry place

Inactive Ingredients



croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Compare to Claritin-D® 12 Hour

active ingredients

Loratadine-D 12 Hour

Pseudoephedrine Sulfate 120 mg / Loratadine 5 mg

Extended Release Tablets

Nasal Decongestant / Antihistamine

Relief of:

Nasal and Sinus Congestion Due to Colds or Allergies

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose Due to Allergies

Indoor & Outdoor Allergies

actual size

Non-Drowsy*

*When taken as directed.

10 Tablets

See Drug Facts Panel.

12 Hour Allergy & Congestion


* Please review the disclaimer below.