Sinus And Headache Daytime, Non-drowsy
Acetaminophen, Phenylephrine Hcl
Walgreen Company
Human Otc Drug
NDC 0363-5580Sinus And Headache Daytime, Non-drowsy also known as Acetaminophen, Phenylephrine Hcl is a human otc drug labeled by 'Walgreen Company'. National Drug Code (NDC) number for Sinus And Headache Daytime, Non-drowsy is 0363-5580. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Sinus And Headache Daytime, Non-drowsy drug includes Acetaminophen - 325 mg/1 Phenylephrine Hydrochloride - 5 mg/1 . The currest status of Sinus And Headache Daytime, Non-drowsy drug is Active.
Drug Information:
| Drug NDC: | 0363-5580 |
| 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 And Headache Daytime, Non-drowsy |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Sinus And Headache |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Daytime, Non-Drowsy |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Acetaminophen, 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: | Tablet, Coated |
| 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: | ACETAMINOPHEN - 325 mg/1
PHENYLEPHRINE HYDROCHLORIDE - 5 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: | 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: | 17 Mar, 2008 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 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, 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: | 1046378
|
| 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: | 362O9ITL9D
04JA59TNSJ
|
| 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 alpha1-Agonists [MoA]
alpha-1 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 |
|---|
| 0363-5580-07 | 3 BLISTER PACK in 1 CARTON (0363-5580-07) / 12 TABLET, COATED in 1 BLISTER PACK | 17 Mar, 2008 | 07 Apr, 2023 | No |
| 0363-5580-08 | 2 BLISTER PACK in 1 CARTON (0363-5580-08) / 12 TABLET, COATED in 1 BLISTER PACK | 17 Mar, 2008 | 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 pain reliever/fever reducer nasal decongestant
Product Elements:
Sinus and headache daytime, non-drowsy acetaminophen, phenylephrine hcl acetaminophen acetaminophen phenylephrine hydrochloride phenylephrine croscarmellose sodium crospovidone, unspecified d&c yellow no. 10 fd&c blue no. 1 fd&c red no. 40 fd&c yellow no. 6 gelatin, unspecified hydroxypropyl cellulose, unspecified hypromellose, unspecified ferrosoferric oxide ferric oxide red ferric oxide yellow magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified povidone, unspecified starch, corn propylene glycol shellac silicon dioxide stearic acid titanium dioxide l;8
Indications and Usage:
Uses temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: headache minor aches and pains nasal congestion sinus congestion and pressure helps decongest sinus openings and passages promotes sinus drainage helps clear nasal passages temporarily reduces fever
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: more than 4,000 mg in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: skin reddening blisters rash if a skin reaction occurs, stop use and seek medical help right away. do not use with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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. if you have ever had an allergic reac
Read more...tion to this product or any of its ingredients ask a doctor before use if you have liver disease thyroid disease heart disease diabetes difficulty in urination due to enlargement of the prostate gland high blood pressure ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. when using this product do not exceed recommended dosage. stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of accidental overdose, get medical help or contact a poison control center (1-800-222-1222) right away. prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do Not Use:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: more than 4,000 mg in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: skin reddening blisters rash if a skin reaction occurs, stop use and seek medical help right away. do not use with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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. if you have ever had an allergic reaction to this product or any of its ingredients ask a doctor before use if you have liver disease thyroid disease heart disease diabetes difficulty in urination due to enlargement of the prostate gland high blood pressure ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. when using this product do not exceed recommended dosage. stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of accidental overdose, get medical help or contact a poison control center (1-800-222-1222) right away. prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
When Using:
When using this product do not exceed recommended dosage.
Dosage and Administration:
Directions do not take more than directed adults and children 12 years and over take 2 gelcaps every 4 hours do not take more than 10 gelcaps in 24 hours children under 12 years: ask a doctor
Stop Use:
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel walgreens compare to tylenol® sinus + headache daytime active ingredients â â ndc 0363-5580-08 daytime ⢠non-drowsy sinus & headache acetaminophen / pain reliever / fever reducer phenylephrine hcl / nasal decongestant ⢠relieves headache, nasal congestion & sinus pressure 24 gelcaps actual size tamper evident: do not use if package is opened or if blister unit is torn, broken or shows any signs of tampering walgreens pharmacist recommended walgreens pharmacist survey â â this product is not manufactured or distributed by mcneil consumer healthcare, owner of the registered trademark tylenol® sinus + headache daytime. 50844 org021655808 distributed by: walgreen co. 200 wilmot rd., deerfield, il 60015 walgreens 100% satisfaction guaranteed walgreens.com ©2017 walgreen co. walgreens 44-558 walgreens 44-558
Further Questions:
Questions or comments? 1-800-426-9391