Fexofenadine Hcl And Pseudoephedrine Hci
Dr. Reddy's Laboratories Inc.
Human Otc Drug
NDC 43598-823Fexofenadine Hcl And Pseudoephedrine Hci is a drug for further processing labeled by 'Dr. Reddy's Laboratories Inc.'. National Drug Code (NDC) number for Fexofenadine Hcl And Pseudoephedrine Hci is 43598-823. This drug is available in dosage form of Tablet, Extended Release. The names of the active, medicinal ingredients in Fexofenadine Hcl And Pseudoephedrine Hci drug includes Fexofenadine Hydrochloride - 60 mg/1 Pseudoephedrine Hydrochloride - 120 mg/1 . The currest status of Fexofenadine Hcl And Pseudoephedrine Hci drug is Active.
Drug Information:
| Drug NDC: | 43598-823 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Fexofenadine Hcl And Pseudoephedrine Hci |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Fexofenadine Hcl And Pseudoephedrine Hci |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dr. Reddy's Laboratories Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Extended Release |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | FEXOFENADINE HYDROCHLORIDE - 60 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE - 120 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 18 Jul, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA076667 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Dr. Reddy's Laboratories Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 997406
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 2S068B75ZU
6V9V2RYJ8N
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Adrenergic alpha-Agonists [MoA]
Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
alpha-Adrenergic Agonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 43598-823-14 | 4 BLISTER PACK in 1 CARTON (43598-823-14) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 18 Jul, 2019 | N/A | No |
| 43598-823-31 | 6 BLISTER PACK in 1 CARTON (43598-823-31) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 18 Jul, 2019 | N/A | No |
| 43598-823-35 | 2 BLISTER PACK in 1 CARTON (43598-823-35) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 31 Oct, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose antihistamine nasal decongestant
Product Elements:
Fexofenadine hcl and pseudoephedrine hci fexofenadine hcl and pseudoephedrine hci fexofenadine hydrochloride fexofenadine mannitol pseudoephedrine hydrochloride pseudoephedrine powdered cellulose starch, corn croscarmellose sodium silicon dioxide ferric oxide red magnesium stearate hypromelloses triethyl citrate r;195 buff white to pale yellow color and other layer light red to red color carton
Indications and Usage:
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 throat temporarily relives 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:
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 parkinsons 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 disease thyroid disease glaucoma high blood pressure diabetes trouble urinating due to an enlarged prostate gland kidney disease. your doctor should determine if you need a different dose. when using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do 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
Read more...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 you 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.
Do Not Use:
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 parkinsons 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 disease thyroid disease glaucoma high blood pressure diabetes trouble urinating due to an enlarged prostate gland kidney disease. your doctor should determine if you need a different dose. when using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do 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 fever you 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.
When Using:
When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do 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).
Dosage and Administration:
Directions do not divide, crush, chew or dissolve the tablet; swallow tablet whole adults 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 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor
Stop Use:
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 fever you get nervous, dizzy, or sleepless
Package Label Principal Display Panel:
Principal display panel blister carton
Further Questions:
Questions? call 1-888-375-3784 distributed by: dr. reddys laboratories, inc. princeton, nj 08540 made in india