Daytime Nighttime Cold And Flu

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl

Walgreen Company
Human Otc Drug
NDC 0363-0567

Daytime Nighttime Cold And Flu also known as Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl is a human otc drug labeled by 'Walgreen Company'. National Drug Code (NDC) number for Daytime Nighttime Cold And Flu is 0363-0567. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Daytime Nighttime Cold And Flu drug includes . The currest status of Daytime Nighttime Cold And Flu drug is Active.

Drug Information:

Drug NDC:	0363-0567
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 Cold And Flu
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:	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:	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:	06 Sep, 2012
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, 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:	1043400 1113705 1484901
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:
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
0363-0567-02	1 KIT in 1 CARTON (0363-0567-02) * 355 mL in 1 BOTTLE (0363-0401-40) * 355 mL in 1 BOTTLE (0363-0666-40)	06 Sep, 2012	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

Daytime Nighttime Cold And Flu

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl

Kit
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NDC: 0363-0567

Severe Cold And Flu

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl

Solution
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NDC: 0363-0623

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Daytime Nighttime Cold Flu Relief

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Capsule, Liquid Filled
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Cold And Flu Daytime-nighttime

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl

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NDC: 11673-984

Daytime Nighttime Cold Flu Relief

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl

Kit
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NDC: 21130-901

Cold And Flu Nighttime Severe

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl

Tablet, Film Coated
Mechanical Servants, LLC
NDC: 29485-5053

Daytime Nighttime Cold And Flu Relief Multi-symptom

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl

Kit
MEIJER, INC.
NDC: 41250-653

Careone Nighttime Severe Cold And Flu

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl

Solution
American Sales Company
NDC: 41520-561

Purpose:

Purpose pain reliever/fever reducer cough suppressant antihistamine

Purpose pain reliever/fever reducer cough suppressant nasal decongestant

Product Elements:

Daytime nighttime cold and flu acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl cold and flu acetaminophen, dextromethorphan hbr, doxylamine succinate acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine alcohol anhydrous citric acid d&c yellow no. 10 fd&c green no. 3 fd&c yellow no. 6 high fructose corn syrup polyethylene glycol, unspecified propylene glycol water saccharin sodium sodium citrate, unspecified form clear, bright green anise / cooling menthol aroma cold and flu acetaminophen, dextromethorphan hbr, phenylephrine hcl acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine butylated hydroxyanisole edetate disodium fd&c yellow no. 6 glycerin menthol, unspecified form sodium phosphate, monobasic, unspecified form polyethylene glycol, unspecified propylene glycol water saccharin sodium sucrose xanthan gum clear with fruit

Indications and Usage:

Uses temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing

Uses temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever

Warnings:

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 glaucoma cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland persistent or chronic cough as occurs with smoking, asthma, or emphysema a sodium-restricted diet ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin when using this product excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness stop use and ask a doctor if pain 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 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: 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.

r 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. 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 heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, or emphysema 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 you get nervous, dizzy or sleepless pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 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 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: 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 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 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 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. 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 glaucoma cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland persistent or chronic cough as occurs with smoking, asthma, or emphysema a sodium-restricted diet ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin when using this product excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness stop use and ask a doctor if pain 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 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: 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 adult takes more than 4,000 mg of acetaminophen in 24 hours child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 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 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 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. 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 heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, or emphysema 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 you get nervous, dizzy or sleepless pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 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 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: 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 excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness

When using this product do not use more than directed

Dosage and Administration:

Directions take only as directed see overdose warning only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 ml every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Directions take only as directed see overdose warning only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 ml every 4 hrs children 6 to under 12 yrs 15 ml every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use

Stop Use:

Stop use and ask a doctor if pain 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 could be signs of a serious condition.

Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 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 could be signs of a serious condition.

Package Label Principal Display Panel:

Principal display panel day & night pack walgreens walgreens pharmacist recommended compare to the active ingredients in vicks ® dayquil ® & vicks ® nyquil ® daytime non-drowsy cold & flu acetaminophen / aches / fever / sore throat dextromethorphan hbr / cough phenylephrine hcl / nasal congestion multi-symptom pain reliever, fever reducer, cough suppressant & nasal decongestant antihistamine free alcohol free nighttime cold & flu acetaminophen / aches / fever / sore throat dextromethorphan hbr / cough doxylamine succinate / sneezing / runny nose multi-symptom pain reliever, fever reducer, cough suppressant & antihistamine alcohol 10% 2 - 12 fl oz (355 ml) bottles / total 24 fl oz (1.5 pt) (710 ml) cold and flu image 1 cold and flu image 2

Further Questions:

Questions or comments? 1-800-719-9260

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.