Sinus Pe Congestion
Diphenhydramine Hcl, Phenylephrine Hcl
Walgreen Company
Human Otc Drug
NDC 0363-4534Sinus Pe Congestion also known as Diphenhydramine Hcl, Phenylephrine Hcl is a human otc drug labeled by 'Walgreen Company'. National Drug Code (NDC) number for Sinus Pe Congestion is 0363-4534. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Sinus Pe Congestion drug includes . The currest status of Sinus Pe Congestion drug is Active.
Drug Information:
| Drug NDC: | 0363-4534 |
| 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: | Sinus Pe Congestion |
| 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: | Diphenhydramine Hcl, Phenylephrine Hcl |
| 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: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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: | OTC MONOGRAPH FINAL |
| 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: | 19 Jan, 2022 |
| 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: | part341 |
| 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, 2024 |
| 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: | 1049182
1052928
1926601
|
| 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. |
| UPC: | 0051281000074
|
| UPC stands for Universal Product Code. |
| UNII: | |
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0363-4534-09 | 1 KIT in 1 PACKAGE, COMBINATION (0363-4534-09) * 12 TABLET, FILM COATED in 1 BLISTER PACK (0363-7453-42) * 8 TABLET, FILM COATED in 1 BLISTER PACK (0363-7485-40) | 19 Jan, 2022 | 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 nasal decongestant
Purpose antihistamine nasal decongestant
Product Elements:
Sinus pe congestion diphenhydramine hcl, phenylephrine hcl sinus pe congestion daytime phenylephrine hcl phenylephrine hydrochloride phenylephrine croscarmellose sodium dextrose monohydrate dibasic calcium phosphate dihydrate fd&c red no. 40 lecithin, soybean magnesium stearate maltodextrin microcrystalline cellulose silicon dioxide carboxymethylcellulose sodium, unspecified trisodium citrate dihydrate titanium dioxide 44;453 sinus pe congestion nighttime diphenhydramine hcl, phenylephrine hcl diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine croscarmellose sodium dibasic calcium phosphate dihydrate fd&c blue no. 1 aluminum lake hypromellose, unspecified magnesium stearate microcrystalline cellulose polydextrose polyethylene glycol, unspecified silicon dioxide stearic acid titanium dioxide triacetin 44;485
Indications and Usage:
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion sneezing (nighttime only) runny nose (nighttime only) itchy, watery eyes (nighttime only) itching of the nose or throat (nighttime only) temporarily relieves these symptoms due to the common cold: nasal congestion sneezing (nighttime only) runny nose (nighttime only) temporarily relieves sinus congestion and pressure
Warnings:
Warnings do not use 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. with any other product containing diphenhydramine, even one used on skin (nighttime only) ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis (nighttime only) glaucoma (nighttime only) ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. (nighttime only) when using this product do not exceed recommended dosage excitability may occur, especially in children (nighttime only) marked drowsiness may occur (nighttime only) alcohol, sedatives, and tranqui
Read more...lizers may increase drowsiness (nighttime only) avoid alcoholic beverages (nighttime only) use caution when driving a motor vehicle or operating machinery (nighttime only) stop use and ask a doctor if symptoms do not improve within 7 days or occur with fever nervousness, dizziness, or sleeplessness occur 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. read each section carefully. do not take daytime and nighttime products at the same time.
Do Not Use:
Warnings do not use 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. with any other product containing diphenhydramine, even one used on skin (nighttime only) ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis (nighttime only) glaucoma (nighttime only) ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. (nighttime only) when using this product do not exceed recommended dosage excitability may occur, especially in children (nighttime only) marked drowsiness may occur (nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only) avoid alcoholic beverages (nighttime only) use caution when driving a motor vehicle or operating machinery (nighttime only) stop use and ask a doctor if symptoms do not improve within 7 days or occur with fever nervousness, dizziness, or sleeplessness occur 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. read each section carefully. do not take daytime and nighttime products at the same time.
When Using:
When using this product do not exceed recommended dosage excitability may occur, especially in children (nighttime only) marked drowsiness may occur (nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only) avoid alcoholic beverages (nighttime only) use caution when driving a motor vehicle or operating machinery (nighttime only)
Dosage and Administration:
Directions adults and children 12 years and over take 1 tablet every 4 hours do not take more than 6 tablets in 24 hours children under 12 years: do not use
Stop Use:
Stop use and ask a doctor if symptoms do not improve within 7 days or occur with fever nervousness, dizziness, or sleeplessness occur
Package Label Principal Display Panel:
Principal display panel day & night pack ndc 0363-4534-09 walgreens walgreens pharmacist recommended compare to the active ingredients in sudafed pe ® day + night sinus congestion daytime non-drowsy sinus pe congestion phenylephrine hci 10 mg / nasal decongestant maximum strength relieves sinus pressure & congestion pseudoephedrine free 12 tablets actual size nighttime sinus pe congestion diphenhydramine hcl 25 mg / antihistamine pheny lephrine hcl 10 mg / nasal decongestant relieves itchy, water eyes, runny nose & itchy throat pseudoephedrine free 8 tablets actual size total 20 tablets tamper evident: do not use if package is opened or if blister unit is torn, broken or shows any signs of tampering our pharmacists recommend the walgreens brand. we invite you to compare to national brands. this product is not manufactured or distributed by johnson & johnson corporation, owner of the registered trademark sudafed pe ® day + night sinus congestion. 50844 org082045348509 distributed by: walgreen co. 200 wilmont rd., deerfield, il 60015 100% satisfaction guaranteed walgreens.com ©2021 walgreen co. walgreens 44-453485-09 walgreens 44-453485-09
Further Questions:
Questions or comments? 1-800-426-9391