Daytime And Nighttime Cold And Flu Maximum Strength

Acetaminophen, Dextromethorphan Hbr,guaifenesin, Phenylephrine Hcl / Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl


Walgreens
Human Otc Drug
NDC 0363-0775
Daytime And Nighttime Cold And Flu Maximum Strength also known as Acetaminophen, Dextromethorphan Hbr,guaifenesin, Phenylephrine Hcl / Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl is a human otc drug labeled by 'Walgreens'. National Drug Code (NDC) number for Daytime And Nighttime Cold And Flu Maximum Strength is 0363-0775. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Daytime And Nighttime Cold And Flu Maximum Strength drug includes . The currest status of Daytime And Nighttime Cold And Flu Maximum Strength drug is Active.

Drug Information:

Drug NDC: 0363-0775
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 And Nighttime Cold And Flu Maximum Strength
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base: Daytime And Nighttime Cold And 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, Dextromethorphan Hbr, Doxylamine Succinate, 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: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: 01 Jun, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 24 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: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:0311917134673
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
0363-0775-243 BLISTER PACK in 1 CARTON (0363-0775-24) / 1 KIT in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK01 Jun, 2022N/ANo
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:

Purposes pain reliever/fever reducer cough suppressant antihistamine nasal decongestant

Purposes pain reliever/fever reducer cough suppressant expectorant nasal decongestant

Product Elements:

Daytime and nighttime cold and flu maximum strength acetaminophen, dextromethorphan hbr,guaifenesin, phenylephrine hcl / acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl daytime cold and flu maximum strength acetaminophen, dextromethorphan hbr,guaifenesin, phenylephrine hcl fd&c yellow no. 6 gelatin glycerin polyethylene glycol 400 povidone k30 propylene glycol water sorbitol sorbitan titanium dioxide acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine guaifenesin guaifenesin oblong 78 nighttime cold and flu maximum strength acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl d&c yellow no. 10 fd&c blue no. 1 gelatin glycerin polyethylene glycol 400 povidone k30 propylene glycol water sorbitol sorbitan sodium hydroxide titanium dioxide acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine phenylephrine hydrochloride phenylephrine oblong 72

Indications and Usage:

Uses • temporarily relieves these common cold and flu symptoms: sinus congestion and pressure cough minor aches and pains headache nasal congestion sore throat runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever • controls cough to help you get to sleep • temporarily reduces fever

Uses • temporarily relieves common cold and flu symptoms: sinus congestion and pressure cough minor aches and pains headache nasal congestion sore throat • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • controls cough to help you get to sleep • temporarily reduces fever

Warnings:

Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take • more than 12 softgels in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks daily 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 • 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 con
ditions, 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 • liver disease • heart disease • diabetes • high blood pressure • thyroid disease • trouble urinating due to enlarged prostate gland • glaucoma • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough such 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 • taking the blood thinning drug warfarin • taking sedatives or tranquilizers when using this product • do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if • 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 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 right away (1-800-222-1222). quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: • more than 12 softgels in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks daily 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 • 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 con
ditions, 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 • liver disease • heart disease • diabetes • high blood pressure • thyroid disease • trouble urinating due to enlarged prostate gland • persistent or chronic cough such 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 taking the blood thinning drug warfarin when using this product do not use more than directed stop use and ask a doctor if • 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 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 right away (1-800-222-1222). 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 liver warning: this product contains acetaminophen. severe liver damage may occur if you take • more than 12 softgels in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks daily 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 • 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. ask a doctor before use if you have • liver disease • heart disease • diabetes • high blood pressure • thyroid disease • trouble urinating due to enlarged prostate gland • glaucoma • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough such 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 • taking the blood thinning drug warfarin • taking sedatives or tranquilizers when using this product • do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if • 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 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 right away (1-800-222-1222). quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: • more than 12 softgels in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks daily 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 • 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. ask a doctor before use if you have • liver disease • heart disease • diabetes • high blood pressure • thyroid disease • trouble urinating due to enlarged prostate gland • persistent or chronic cough such 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 taking the blood thinning drug warfarin when using this product do not use more than directed stop use and ask a doctor if • 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 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 right away (1-800-222-1222). 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 • do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery

When using this product do not use more than directed

Dosage and Administration:

Directions • do not take more than directed (see overdose warning) • do not take more than 12 softgels 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

Directions • do not take more than directed (see overdose warning) • do not take more than 12 softgels 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

Stop Use:

Stop use and ask a doctor if • 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 fever, rash, or headache that lasts. these could be signs of a serious condition

Stop use and ask a doctor if • 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 fever, rash, or headache that lasts. these could be signs of a serious condition.

Package Label Principal Display Panel:

Principal display panel 630t-walgreens-maxstrength-coldflu-ifc-24s

Further Questions:

Questions or comments? call 1-877-290-4008

Questions or comments? call 1-877-290-4008


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.