NDC 43598-823 Fexofenadine Hcl And Pseudoephedrine Hci

Fexofenadine Hcl And Pseudoephedrine Hci

NDC Product Code 43598-823

NDC Code: 43598-823

Proprietary Name: Fexofenadine Hcl And Pseudoephedrine Hci 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: Fexofenadine Hcl And Pseudoephedrine Hci 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 - BUFF WHITE TO PALE YELLOW COLOR AND OTHER LAYER LIGHT RED TO RED COLOR)
Shape: CAPSULE (C48336)
Size(s):
16 MM
Imprint(s):
R;195
Score: 1

NDC Code Structure

  • 43598 - Dr. Reddy's Laboratories Inc.
    • 43598-823 - Fexofenadine Hcl And Pseudoephedrine Hci

NDC 43598-823-14

Package Description: 4 BLISTER PACK in 1 CARTON > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

NDC 43598-823-31

Package Description: 6 BLISTER PACK in 1 CARTON > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

NDC Product Information

Fexofenadine Hcl And Pseudoephedrine Hci with NDC 43598-823 is a a human over the counter drug product labeled by Dr. Reddy's Laboratories Inc.. The generic name of Fexofenadine Hcl And Pseudoephedrine Hci is fexofenadine hcl and pseudoephedrine hci. The product's dosage form is tablet, extended release and is administered via oral form.

Labeler Name: Dr. Reddy's Laboratories Inc.

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.

Fexofenadine Hcl And Pseudoephedrine Hci 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.

  • FEXOFENADINE HYDROCHLORIDE 60 mg/1
  • PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1

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.

  • MANNITOL (UNII: 3OWL53L36A)
  • POWDERED CELLULOSE (UNII: SMD1X3XO9M)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

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: Dr. Reddy's Laboratories Inc.
Labeler Code: 43598
FDA Application Number: ANDA076667 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: ANDA - A product marketed under an approved Abbreviated 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: 07-18-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Fexofenadine and Pseudoephedrine

Fexofenadine and Pseudoephedrine is pronounced as (fex oh fen' a deen) (soo doe e fed' rin)

Why is fexofenadine and pseudoephedrine medication prescribed?
The combination of fexofenadine and pseudoephedrine is used in adults and children 12 years of age and older to relieve the allergy symptoms of seasonal allergic rhinitis...
[Read More]

* Please review the disclaimer below.

Fexofenadine Hcl And Pseudoephedrine Hci Product Label Images

Fexofenadine Hcl And Pseudoephedrine Hci 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

Active Ingredient(S)

Fexofenadine HCl USP, 60 mgPseudoephedrine HCl USP,120 mg

Purpose

AntihistamineNasal decongestant

Use(S)

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throattemporarily relives 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

Do Not Use

  • If 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.if you have difficulty swallowing

Ask A Doctor Before Use If You Have

  • Heart diseasethyroid disease glaucomahigh blood pressure diabetestrouble urinating due to an enlarged prostate glandkidney disease. Your doctor should determine if you need a different dose.

When Using This Product

  • Do not take more than directeddo not take at the same time as aluminum or magnesium antacidsdo not take with fruit juices (see Directions)the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions).

Stop Use And Ask 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 feveryou get nervous, dizzy, or sleepless

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

  • Do not divide, crush, chew or dissolve the tablet; swallow tablet wholeadults and children 12 years of age and over   take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hourschildren under 12 years of agedo not useadults 65 years of age  and olderask a doctorconsumers with kidney diseaseask a doctor

Other Information

  • Safety sealed: do not use if carton is opened or if individual blister units are torn or openedstore between 20° to 25°C (68° to 77°F) store between 20° to 25°C (68° to 77°F) this product meets the requirements of USP dissolution test 3.

Inactive Ingredients

Corn starch, croscarmellose sodium, colloidal silicon dioxide, ferric oxide, hypromellose, kollidon SR, magnesium stearate, mannitol, powder cellulose and triethyl citrate.

Questions?

Call 1-888-375-3784Distributed by:Dr. Reddy’s Laboratories, Inc.Princeton, NJ 08540Made in India

* Please review the disclaimer below.

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