Daytime Nighttime Sinus Relief Maximum Strength
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl,guaifenesin
Walgreens
Human Otc Drug
NDC 0363-0622Daytime Nighttime Sinus Relief Maximum Strength also known as Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl,guaifenesin is a human otc drug labeled by 'Walgreens'. National Drug Code (NDC) number for Daytime Nighttime Sinus Relief Maximum Strength is 0363-0622. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Daytime Nighttime Sinus Relief Maximum Strength drug includes . The currest status of Daytime Nighttime Sinus Relief Maximum Strength drug is Active.
Drug Information:
| Drug NDC: | 0363-0622 |
| 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: | Daytime Nighttime Sinus Relief Maximum Strength |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Daytime Nighttime Sinus Relief |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Maximum Strength |
| 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, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl,guaifenesin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Walgreens |
| 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: | 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: | 31 Dec, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Apr, 2023 |
| 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: | 17 Dec, 2025 |
| 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: | Walgreens
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1297288
1656815
1657147
|
| 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: | 0311917186207
|
| 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 |
|---|
| 0363-0622-24 | 1 KIT in 1 KIT (0363-0622-24) * 8 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK * 16 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK | 31 Dec, 2018 | 23 Apr, 2023 | 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 for daytime pain reliever cough suppressant expectorant nasal decongestant
Purpose for nighttime pain reliever cough suppressant antihistamine nasal decongestant
Product Elements:
Daytime nighttime sinus relief maximum strength acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl,guaifenesin nighttime sinus relief maximum strength acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine phenylephrine hydrochloride phenylephrine d&c yellow no. 10 fd&c blue no. 1 gelatin glycerin polyethylene glycol, unspecified povidone propylene glycol water sorbitan sorbitol shellac sodium hydroxide titanium dioxide mannitol 116;42a daytime sinus relief maximum strength acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine guaifenesin guaifenesin fd&c red no. 40 fd&c yellow no. 6 gelatin glycerin polyethylene glycol, unspecified povidone propylene glycol water sorbitan sorbitol titanium dioxide mannitol 341;12a
Indications and Usage:
Uses daytime temporarily relieves nasal congestion headache cough due to inhaled irritants sinus congestion and pressure minor aches and pains promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive nighttime temporarily relieves nasal congestion cough due to inhaled irritants headache sinus congestion and pressure minor aches and pains runny nose and sneezing promotes nasal and/or sinus drainage
Warnings:
Warnings daytime and nighttime liver warning: these products contain acetaminophen. severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours 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 daytime and nighttime 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 parkinsonâs 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
Read more... doctor before use if you have daytime liver disease high blood pressure diabetes heart disease thyroid disease trouble urinating due to an enlarged prostate gland a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) nighttime liver disease high blood pressure diabetes heart disease thyroid disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus ask a doctor or pharmacist before use if you are daytime taking the blood thinning drug warfarin nighttime taking the blood thinning drug warfarin taking sedatives or tranquilizers when using this product, daytime do not use more than directed nighttime do not use more than directed excitability may occur, especially in children marked 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 daytime and nighttime nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. these coukld be signs of a serious condition. if pregnant or breast-feeding, daytime and nighttime ask a health professional before use. keep out of reach of children. daytime and nighttime overdose warning : taking more than the recommended dose can cause liver damage. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. quick 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 daytime and nighttime liver warning: these products contain acetaminophen. severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours 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 daytime and nighttime 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 parkinsonâs 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 daytime liver disease high blood pressure diabetes heart disease thyroid disease trouble urinating due to an enlarged prostate gland a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) nighttime liver disease high blood pressure diabetes heart disease thyroid disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus ask a doctor or pharmacist before use if you are daytime taking the blood thinning drug warfarin nighttime taking the blood thinning drug warfarin taking sedatives or tranquilizers when using this product, daytime do not use more than directed nighttime do not use more than directed excitability may occur, especially in children marked 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 daytime and nighttime nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. these coukld be signs of a serious condition. if pregnant or breast-feeding, daytime and nighttime ask a health professional before use. keep out of reach of children. daytime and nighttime overdose warning : taking more than the recommended dose can cause liver damage. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. quick 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, daytime do not use more than directed nighttime do not use more than directed excitability may occur, especially in children marked 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 daytime do not take more than directed (see overdose warning) do not take more than 12 softgels (daytime and nighttime) in any 24-hour period adults and children 12 years of age and older: take 2 softgels every 4 hours children under 12 years of age: do not use when using other daytime or nighttime products, carefully read each label to ensure correct dosing nighttime do not take more than directed (see overdose warning) do not take more than 12 softgels (daytime and nighttime) in any 24-hour period adults and children 12 years of age and older: take 2 softgels every 4 hours children under 12 years of age: do not use when using other daytime or nighttime products, carefully read each label to ensure correct dosing
Stop Use:
Stop use and ask a doctor if daytime and nighttime nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. these coukld be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel compare to maximum strength mucinex® sinus-max® day & mucinex® sinus-max® night active ingredientsâ â daytime sinus relief acetaminophen / pain reliever dextromethorphan hbr / cough suppressant guaifenesin / expectorant phenylephrine hci / nasal decongestant maximum strength alcohol free relieves sinus pressure, headache & congestion controls cough thins & loosens mucus ages 12 years & over softgels** (**liquid-filled capsules) nighttime sinus relief acetaminophen / pain reliever dextromethorphan hbr / cough suppressant doxylamine succinate / antihistamine phenylephrine hci / nasal decongestant maximum strength alcohol free relieves nasal congestion, sinus pressure & pain, runny nose & sneezing controls cough ages 12 years & over softgels* (*liquid-filled capsules) â â this product is not manufactured or distributed by reckitt benckiser, distributor of maximum strength mucinex® sinus-max® day and maximum strength mucinex® sinus-max® night. tamper evident: do not use if blister unit is torn, broken or shows any signs of tampering keep outer carton for complete warnings and product information. distributed by: walgreen co. 200 wilmot rd., deerfield, il 60015 walgreens.com
Product label walgreens daytime nighttime sinus relief acetaminophen 325 mg, dextromethorphan hbr 10 mg, guaifenesin 200 mg, phenylephrine hci 5 mg, acetaminophen 325 mg, dextromethorphan hbr10 mg, doxylamine succinate 6.25 mg, phenylephrine hci 5 mg
Further Questions:
Questions or comments? daytime and nighttime call 1-877-753-3935 monday-friday 9am-5pm est