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  4. Severe Cold And Flu Daytime Non Drowsy Nighttime

Severe Cold And Flu Daytime Non Drowsy Nighttime

Acetaminophen, Dextromethorphan Hydrobromide,guaifenesin, Phenylephrine Hydrochloride / Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride


Walgreens
Human Otc Drug
NDC 0363-9896
Severe Cold And Flu Daytime Non Drowsy Nighttime also known as Acetaminophen, Dextromethorphan Hydrobromide,guaifenesin, Phenylephrine Hydrochloride / Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride is a human otc drug labeled by 'Walgreens'. National Drug Code (NDC) number for Severe Cold And Flu Daytime Non Drowsy Nighttime is 0363-9896. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Severe Cold And Flu Daytime Non Drowsy Nighttime drug includes . The currest status of Severe Cold And Flu Daytime Non Drowsy Nighttime drug is Active.

Drug Information:

Drug NDC: 0363-9896
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: Severe Cold And Flu Daytime Non Drowsy Nighttime
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base: Severe Cold And Flu
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix: DAYTIME NON DROWSY NIGHTTIME
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 Hydrobromide,guaifenesin, Phenylephrine Hydrochloride / Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
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: 05 Jul, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 07 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: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.
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
0363-9896-241 KIT in 1 PACKAGE, COMBINATION (0363-9896-24) * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK05 Jul, 2018N/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.
Other medicines with the same generic name

Severe Cold And Flu Daytime Non Drowsy Nighttime


Acetaminophen & more..

Kit
TopCo Associates LLC
NDC: 36800-667

Severe Cold And Flu Daytime Non Drowsy Nighttime


Acetaminophen & more..

Kit
Walgreens
NDC: 0363-9896

Purpose:

Active ingredients (in each softgel) purposes acetaminophen 325 mg............................pain reliever/fever reducer dextromethorphan hbr 10 mg.............................cough suppressant guaifenesin 200 mg.........................................................expectorant phenylephrine hcl 5 mg......................................nasal decongestant

Active ingredients (in each softgel) purposes acetaminophen 325 mg............................pain reliever/fever reducer dextromethorphan hbr 10 mg.............................cough suppressant doxylamine succinate 6.25 mg.....................................antihistamine phenylephrine hcl 5 mg......................................nasal decongestant

Product Elements:

Severe cold and flu daytime non drowsy nighttime acetaminophen, dextromethorphan hydrobromide,guaifenesin, phenylephrine hydrochloride / acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride severe cold and flu daytime non-drowsy acetaminophen, dextromethorphan hydrobromide,guaifenesin, phenylephrine hydrochloride fd&c red no. 40 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 341 severe cold and flu nightime acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride d&c yellow no. 10 fd&c blue no. 1 gelatin glycerin polyethylene glycol 400 povidone k30 propylene glycol water shellac sodium hydroxide titanium dioxide acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine phenylephrine hydrochloride phenylephrine oblong 116

Indications and Usage:

Uses ■ temporarily relieves common cold/flu symptoms: ■ nasal congestion ■ sinus congestion & pressure ■ cough due to minor throat & bronchial irritation ■ minor aches & pains ■ headache ■ fever ■ sore throat ■ reduces swelling of nasal passages ■ temporarily restores freer breathing through the nose ■ 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.

Directions ■ take only as directed - see overdose warning ■ do not exceed 4 doses per 24 hours adults & children 12 years & over 2 softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use ■ when using other nighttime or daytime products, carefully read each label to ensure correct dosing

Uses ■ temporarily relieves common cold/flu symptoms: ■ nasal congestion ■ sinus congestion & pressure ■ cough due to minor throat & bronchial irritation ■ cough to help you sleep ■ minor aches & pains ■ headache ■ fever ■ sore throat ■ runny nose & sneezing ■ reduces swelling of nasal passages ■ temporarily restores freer breathing through the nose ■ promotes nasal and/or sinus drainage

Warnings:

Warnings liver warning this product contains acetaminophen. severe liver damage may occur if you take ■ more than 4 doses in 24 hours, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product drug facts (continued) 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.

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.

Warnings liver warning this product contains acetaminophen. severe liver damage may occur if you take ■ more than 4 doses in 24 hours, which is the maximum daily amount for this product ■ 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.

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.

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:

Warnings liver warning this product contains acetaminophen. severe liver damage may occur if you take ■ more than 4 doses in 24 hours, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product drug facts (continued) 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.

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.

Warnings liver warning this product contains acetaminophen. severe liver damage may occur if you take ■ more than 4 doses in 24 hours, which is the maximum daily amount for this product ■ 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.

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.

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.

When Using:

When using this product, do not use more than directed.

When using this product ■ do not use more than directed ■ 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

Dosage and Administration:

Directions ■ take only as directed - see overdose warning ■ do not exceed 4 doses per 24 hours adults & children 12 years & over 2 softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use

Stop Use:

Stop use and ask a doctor if ■ you get nervous, dizzy or sleepless ■ 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 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 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.

Overdosage:

Overdose warning taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Overdose warning taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Package Label Principal Display Panel:

Principal display panel - kit carton day & night pack ndc 0363-9896-24 walgreens compare to vicks® dayquil® severe cold & flu & vicks® nyquil® severe cold & flu active ingredients†† daytime • non-drowsy severe cold & flu acetaminophen / pain reliever / fever reducer dextromethorphan hbr / cough suppressant guaifenesin / expectorant phenylephrine hcl / nasal decongestant dissolves quickly maximum strength actual size 16 softgels nighttime severe cold & flu acetaminophen / pain reliever / fever reducer dextromethorphan hbr / cough suppressant doxylamine succinate / antihistamine phenylephrine hcl / nasal decongestant maximum strength actual size 8 softgels 24 softgels image description

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