Mucus Relief All In One Daytime Nighttime Cold Flu Maximum Strength

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl, Acetaminophen, Diphenhydramine Hcl Phenylephrine Hcl

Walgreens
Human Otc Drug
NDC 0363-9140

Mucus Relief All In One Daytime Nighttime Cold Flu Maximum Strength also known as Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl, Acetaminophen, Diphenhydramine Hcl Phenylephrine Hcl is a human otc drug labeled by 'Walgreens'. National Drug Code (NDC) number for Mucus Relief All In One Daytime Nighttime Cold Flu Maximum Strength is 0363-9140. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Mucus Relief All In One Daytime Nighttime Cold Flu Maximum Strength drug includes . The currest status of Mucus Relief All In One Daytime Nighttime Cold Flu Maximum Strength drug is Active.

Drug Information:

Drug NDC:	0363-9140
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:	Mucus Relief All In One Daytime Nighttime Cold Flu Maximum Strength
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base:	Mucus Relief All In One Daytime Nighttime Cold Flu
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, Guaifenesin, Phenylephrine Hcl, Acetaminophen, Diphenhydramine Hcl Phenylephrine Hcl
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:
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:	30 Sep, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	13 May, 2026
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:	Walgreens
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1116572 1375932 1424850
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:	0311917177786
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
0363-9140-12	1 KIT in 1 KIT (0363-9140-12) * 177 mL in 1 BOTTLE, PLASTIC * 177 mL in 1 BOTTLE, PLASTIC	30 Sep, 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.

Other medicines with the same generic name

Mucus Relief All In One Daytime Nighttime Cold Flu Maximum Strength

Acetaminophen & more..

Kit
Walgreens
NDC: 0363-9140

Purpose:

Purposes for day time pain reliever/fever reducer cough suppressant expectorant nasal decongestant

Purpose for night time pain reliever/fever reducer antihistamine/cough suppressant nasal decongestant

Product Elements:

Mucus relief all in one daytime nighttime cold flu maximum strength acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, acetaminophen, diphenhydramine hcl phenylephrine hcl mucus relief all in one maximum strength acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine acetaminophen acetaminophen anhydrous citric acid edetate disodium fd&c red no. 40 propylene glycol water trisodium citrate dihydrate fd&c blue no. 1 glycerin propyl gallate sodium benzoate sorbitol sucralose xanthan gum mucus relief all in one maximum strength acetaminophen, diphenhydramine hcl phenylephrine hcl acetaminophen acetaminophen diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine anhydrous citric acid edetate disodium fd&c blue no. 1 fd&c red no. 40 propylene glycol water sodium benzoate trisodium citrate dihydrate glycerin propyl gallate sorbitol sucralose xanthan gum

Indications and Usage:

Uses daytime temporarily relieves these common cold and flu symptoms cough nasal congestion minor aches and pain sore throat headache stuffy nose sinus congestion and pressure temporarily reduces fever help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make cough more productive nighttime temporarily relieves these common cold and flu symptoms cough nasal congestion minor aches and pains sore throat headache sinus congestion and pressure runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever temporarily reduces fever controls cough to help you get to sleep

Warnings:

the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. for children under 12 years of age 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. with any other drug containing diphenhydramine, even one used on the skin if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certan 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 daytime liver disease heart disease diabetes thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema cough that occurs with too much phlegm (mucus) nighttime liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis 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 drowsinessmay occur alcohol, sedative, and tranquilizers may increase drowsiness avoid alcohol drinks be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if daytime nervousness, dizziness or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 7 days fever gets worse, or last more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with rash, or headache that lasts. these could be signs of a serious condition. nighttime nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 7 days fever gets worse, or last more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with fever, rash, or headache that lasts. 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. overdose warning: taking more than the recommended dose (overdose) may 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 adult 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 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 sore throat warning : if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use daytime 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. for children under 12 years of age 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. with any other drug containing diphenhydramine, even one used on the skin if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certan 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 daytime liver disease heart disease diabetes thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema cough that occurs with too much phlegm (mucus) nighttime liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis 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 drowsinessmay occur alcohol, sedative, and tranquilizers may increase drowsiness avoid alcohol drinks be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if daytime nervousness, dizziness or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 7 days fever gets worse, or last more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with rash, or headache that lasts. these could be signs of a serious condition. nighttime nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 7 days fever gets worse, or last more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with fever, rash, or headache that lasts. 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. overdose warning: taking more than the recommended dose (overdose) may 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 adult 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 drowsinessmay occur alcohol, sedative, and tranquilizers may increase drowsiness avoid alcohol drinks 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 6 doses in any 24-hour period measure only with dosing cup provided. do not use any other dosing device keep dosing cup with product ml= milliliter dose as follows or as directed by a doctor adult and children 12 years of age and over: 20 ml in dosing cup provided avery 4 hours children under 12 years of age do not use nighttime do not take more than directed (see overdose warning) do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. do not use any other dosing device keep dosing cup with product ml= milliliter dose as follows or as directed by a doctor adult and children 12 years and older: 20 ml every 4 hours while symptoms last children under 12 years of age do not use

Stop Use:

Stop use and ask a doctor if daytime nervousness, dizziness or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 7 days fever gets worse, or last more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with rash, or headache that lasts. these could be signs of a serious condition. nighttime nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 7 days fever gets worse, or last more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with fever, rash, or headache that lasts. these could be signs of a serious condition.

Package Label Principal Display Panel:

Principal display panel daytime cold & flu acetaminophen 650 mg / pain reliever / fever reducer dextromethorphan hbr 20 mg / cough suppressant guaifenesin 400 mg / expectorant phenylephrine hcl 10 mg / nasal decongestant maximum strength relieves aches, fever, sore throat, nasal & chest congestion, sinus congestion & pressure controls cough thins & loosen mucus 12 years & older fl oz (ml) compare to maximum strength mucinexÂ® fast-maxÂ® all-in-one cold & flu & night time cold & flu active ingredientâ â nighttime cold & flu acetaminophen 650 mg / pain reliever / fever reducer diphenhydramine hcl 25 mg / antihistamine / cough suppressant phenylephrine hcl 10 mg / nasal decongestant maximum strength relieves cough, fever, sore throat, body pain, sneezing, itchy throat, headache, nasal congestion & runny nose 12 years & older fl oz (ml) questions or comments? call 1-877-753-3935 monday-friday 9am-5pm est tamper evident: do not use if printed safety seal around or under cap is broken or missing â â this product is not manufactured or distributed by reckitt benckiser, distributor of maximum strength mucinexÂ® fast-maxÂ® all-in-one cold & flu & night time cold & flu distributed by: walgreen co. 200 wilmot rd., deerfield, il 60015

Product label walgreens daytime nighttime cold & flu acetaminophen 650, dextromethorphan hbr 20 mg, guaifenesin 400 mg, phenylephrine hcl 10 mg, acetaminophen 650 mg, diphenhydramine hcl 25 mg, phenylephrine hcl 10 mg

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