Wal-zyr D
Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride
Walgreen Company
Human Otc Drug
NDC 0363-0989Wal-zyr D also known as Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride is a human otc drug labeled by 'Walgreen Company'. National Drug Code (NDC) number for Wal-zyr D is 0363-0989. This drug is available in dosage form of Tablet, Film Coated, Extended Release. The names of the active, medicinal ingredients in Wal-zyr D drug includes Cetirizine Hydrochloride - 5 mg/1 Pseudoephedrine Hydrochloride - 120 mg/1 . The currest status of Wal-zyr D drug is Active.
Drug Information:
| Drug NDC: | 0363-0989 |
| 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: | Wal-zyr D |
| 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: | Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Walgreen Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Film Coated, 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: | CETIRIZINE HYDROCHLORIDE - 5 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: | 01 Nov, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 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: | ANDA090922 |
| 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: | Walgreen Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1014571
1014580
|
| 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: | 64O047KTOA
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 |
|---|
| 0363-0989-12 | 2 BLISTER PACK in 1 CARTON (0363-0989-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 01 Nov, 2018 | N/A | No |
| 0363-0989-24 | 4 BLISTER PACK in 1 CARTON (0363-0989-24) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 01 Nov, 2018 | 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:
Active ingredients (in each extended-release tablet) purpose cetirizine hcl, usp 5 mg antihistamine pseudoephedrine hcl, usp 120 mg nasal decongestant
Product Elements:
Wal-zyr d cetirizine hydrochloride and pseudoephedrine hydrochloride cetirizine hydrochloride cetirizine pseudoephedrine hydrochloride pseudoephedrine hydroxypropyl cellulose (1600000 wamw) hypromellose, unspecified magnesium stearate microcrystalline cellulose stearic acid titanium dioxide ammonia ferrosoferric oxide isopropyl alcohol butyl alcohol propylene glycol shellac hydroxyethyl cellulose (4000 mpa.s at 1%) circular 915
Indications and Usage:
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of nose or throat nasal congestion 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 or to an antihistamine containing hydroxyzine. if you are now taking a prescription monoamine oxidase inhibitor (maoi) (cer tain 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 diabetes glaucoma high blood pressure trouble urinating due to an enlarged prostate gland liver or kidney disease. your doctor should determine if you need a different dose. ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. when using this product do not use more than directed drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor veh
Read more...icle or operating machinery stop use and ask a doctor if an allergic reaction to this product occurs. seek medical help right away. you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever if pregnant or breast-feeding if breast-feeding: not recommended if pregnant: 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 at 1-800-222-1222.
Do Not Use:
Warnings do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. if you are now taking a prescription monoamine oxidase inhibitor (maoi) (cer tain 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 diabetes glaucoma high blood pressure trouble urinating due to an enlarged prostate gland liver or kidney disease. your doctor should determine if you need a different dose. ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. when using this product do not use more than directed drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if an allergic reaction to this product occurs. seek medical help right away. you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever if pregnant or breast-feeding if breast-feeding: not recommended if pregnant: 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 at 1-800-222-1222.
When Using:
When using this product do not use more than directed drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions do not break or chew tablet; swallow tablet whole adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. adults 65 years and over ask a doctor children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor
Stop Use:
Stop use and ask a doctor if an allergic reaction to this product occurs. seek medical help right away. you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever
Package Label Principal Display Panel:
Principal display panel - 12 tablet blister pack carton original prescription strength ndc 0363-0989-12 walgreens compare to the active ingredients in zyrtec-d ® 12 hour walgreens pharmacist recommended allergy relief d12 allergy & congestion cetirizine hydrochloride 5 mg / antihistamine pseudoephedrine hydrochloride 120 mg / nasal decongestant 12 hour extended-release tablets, usp indoor & outdoor allergies relief of sneezing, itchy, watery eyes, sinus pressure, runny nose, itchy throat or nose & nasal congestion 12 extended-release tablets actual size principal display panel - 12 tablet blister pack carton
Further Questions:
Questions? call toll free 1-800-818-4555 weekdays