Walgreens Maximum Strength Non Drowsy Day And Night Cold And Flu

Walgreens
Human Otc Drug
NDC 0363-5552

Walgreens Maximum Strength Non Drowsy Day And Night Cold And Flu is a human otc drug labeled by 'Walgreens'. National Drug Code (NDC) number for Walgreens Maximum Strength Non Drowsy Day And Night Cold And Flu is 0363-5552. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Walgreens Maximum Strength Non Drowsy Day And Night Cold And Flu drug includes . The currest status of Walgreens Maximum Strength Non Drowsy Day And Night Cold And Flu drug is Active.

Drug Information:

Drug NDC:	0363-5552
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:	Walgreens Maximum Strength Non Drowsy Day And Night 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:	Walgreens Maximum Strength Non Drowsy Day And Night Cold And Flu
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:	04 Feb, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	25 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:	1086997 1297288 2048714
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
0363-5552-24	1 KIT in 1 CARTON (0363-5552-24) * 2 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	04 Feb, 2020	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

Walgreens Maximum Strength Non Drowsy Day And Night Cold And Flu

Kit
Walgreens
NDC: 0363-9077

Walgreens Maximum Strength Non Drowsy Day And Night Cold And Flu

Kit
Walgreens
NDC: 0363-5552

Purpose:

Purposes pain reliever/fever reducer cough suppressant nasal decongestant

Purposes pain reliever/fever reducer cough suppressant antihistamine nasal decongestant

Product Elements:

Walgreens maximum strength non drowsy day and night cold and flu walgreens maximum strength non drowsy day and night cold and flu maximum strength non drowsy daytime cold and flu acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride propylene glycol gelatin glycerin polyethylene glycol 400 sorbitan sorbitol titanium dioxide fd&c yellow no. 6 food yellow 3 free acid water povidone potassium aluminum disilicate acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine opaque oblong 101 maximum strength nighttime cold and flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride gelatin glycerin water titanium dioxide fd&c blue no. 1 sorbitol propylene glycol polyethylene glycol 400 povidone d&c yellow no. 10 sorbitan potassium aluminum disilicate acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine phenylephrine hydrochloride phenylephrine opaque oblong 102

Indications and Usage:

Uses uses Â· temporarily relieves these symptoms due to a cold or flu: Â· minor aches and pains Â· headache Â· cough Â· sore throat Â· nasal and sinus congestion Â· temporarily reduces fever

Directions directions Â· do not take more than the recommended dose Â· adults and children 12 years and over: take 2 capsules with water every 4 hours. do not exceed 10 capsules in 24 hours or as directed by a doctor. Â· children under 12 years: do not use

Uses uses Â· temporarily relieves these symptoms due to a cold or flu: Â· minor aches and pains Â· headache Â· nasal and sinus congestion Â· cough Â· sore throat Â· runny nose Â· sneezing Â· temporarily reduces fever

Warnings:

Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take Â· more than 4,000 mg of acetaminophen in 24 hours Â· with other drugs containing acetaminophen Â· 3 or more alcoholic drinks every day while using this product allergy alert: acetaminophen may cause severe skin or severe allergic reactions. symptoms may include: Â· skin reddening Â· blisters Â· rash Â· hives Â· facial swelling Â· asthma (wheezing) Â· shock if a skin or general allergic 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:

When Using:

When using this product do not exceed recommended dosage

When using this product â do not exceed recommended dosage â may cause marked drowsiness â avoid alcoholic drinks â alcohol, sedatives, and tranquilizers may increase drowsiness â be careful when driving a motor vehicle or operating machinery â excitability may occur, especially in children

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

Dosage and Administration:

Stop Use:

Spl Patient Package Insert:

Do not take these products at the same time.

Package Label Principal Display Panel:

Principla display panel carton

Further Questions:

Questions or comments? questions or comments? 1-888-333-9792

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.