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  4. Wal Tussin Dm Max Nighttime Wal Tussin Dm Max

Wal Tussin Dm Max Nighttime Wal Tussin Dm Max

Dextromethorphan Hbr, Doxylamine Succinate, Guaifenesin


Walgreen Company
Human Otc Drug
NDC 0363-0913
Wal Tussin Dm Max Nighttime Wal Tussin Dm Max also known as Dextromethorphan Hbr, Doxylamine Succinate, Guaifenesin is a human otc drug labeled by 'Walgreen Company'. National Drug Code (NDC) number for Wal Tussin Dm Max Nighttime Wal Tussin Dm Max is 0363-0913. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Wal Tussin Dm Max Nighttime Wal Tussin Dm Max drug includes . The currest status of Wal Tussin Dm Max Nighttime Wal Tussin Dm Max drug is Active.

Drug Information:

Drug NDC: 0363-0913
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: Wal Tussin Dm Max Nighttime Wal Tussin Dm Max
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: Dextromethorphan Hbr, Doxylamine Succinate, Guaifenesin
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: 27 Oct, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 20 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:Walgreen Company
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1020138
1115329
2056073
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
0363-0913-121 KIT in 1 CARTON (0363-0913-12) * 118 mL in 1 BOTTLE * 118 mL in 1 BOTTLE (0363-1023-26)27 Oct, 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

Wal Tussin Dm Max Nighttime Wal Tussin Dm Max


Dextromethorphan Hbr, Doxylamine Succinate, Guaifenesin

Kit
Walgreen Company
NDC: 0363-0913

Purpose:

Purposes cough suppressant antihistamine

Purposes cough suppressant expectorant

Product Elements:

Wal tussin dm max nighttime wal tussin dm max dextromethorphan hbr, doxylamine succinate, guaifenesin nighttime wal tussin dm max dextromethorphan hbr, doxylamine succinate dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine anhydrous citric acid benzoic acid benzyl alcohol carboxymethylcellulose sodium fd&c blue no. 1 fd&c red no. 40 glycerin menthol polyethylene glycol propylene glycol water sodium benzoate sorbitol sucralose xanthan gum wal tussin dm max dextromethorphan hbr, guaifenesin dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin anhydrous citric acid carboxymethylcellulose sodium fd&c blue no. 1 fd&c red no. 40 glycerin menthol polyethylene glycol propylene glycol water sodium benzoate sodium citrate sorbitol sucralose xanthan gum

Indications and Usage:

Uses • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat • controls the impulse to cough to help you sleep

Uses • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings:

Warnings do not use • to make a child sleepy • 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 • trouble urinating due to an enlarged prostate gland • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough such as occurs with smoking, asthma, or emphysema ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers when using this product • do not use more than directed • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful w
hen driving a motor vehicle or operating machinery • excitability may occur, especially in children stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222).

Warnings do not use 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 • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222).

Do Not Use:

Warnings do not use • to make a child sleepy • 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 • trouble urinating due to an enlarged prostate gland • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough such as occurs with smoking, asthma, or emphysema ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers when using this product • do not use more than directed • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222).

Warnings do not use 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 • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222).

When Using:

When using this product • do not use more than directed • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children

Dosage and Administration:

Directions • measure only with dosing cup provided • keep dosing cup with product • ml = milliliter • do not take more than 4 doses in any 24-hour period • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 ml every 6 hours children under 12 years do not use

Directions • do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • keep dosing cup with product • ml = milliliter • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 ml every 4 hours children under 12 years do not use

Stop Use:

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition.

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition.

Package Label Principal Display Panel:

Package/label principal display panel day & night pack compare to robitussin® maximum strength cough + chest congestion dm & robitussin® maximum strength nighttime cough dm active ingredients adult non-drowsy wal-tussin® dm max cough & chest congestion dm dextromethorphan hbr / cough suppressant guaifenesin / expectorant maximum strength alcohol free relieves cough, chest congestion & mucus for maximum strength mucus relief 12 years & older see new dosing raspberry menthol flavor adult nighttime wal-tussin® dm max cough dextromethorphan hbr / cough suppressant doxylamine succinate / antihistamine maximum strength alcohol free relieves cough, itchy throat & runny nose 12 years & older see new dosing raspberry, blackberry & menthol flavor total 8 fl oz (236 ml) – 2 x 4 fl oz (118 ml) wal-tussin dm max nighttime wal-tussin dm max carton image 1 wal-tussin dm max nighttime wal-tussin dm max carton image 2

Further Questions:

Questions or comments? 1-800-719-9260

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.

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