NDC 0363-0324 Wal-tussin Dm

Dextromethorphan Hbr, Guaifenesin

NDC Product Code 0363-0324

NDC 0363-0324-28

Package Description: 1 BOTTLE in 1 CARTON > 354 mL in 1 BOTTLE

NDC Product Information

Wal-tussin Dm with NDC 0363-0324 is a a human over the counter drug product labeled by Walgreen Company. The generic name of Wal-tussin Dm is dextromethorphan hbr, guaifenesin. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Walgreen Company

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Wal-tussin Dm Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/10mL
  • GUAIFENESIN 200 mg/10mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • DEXTROSE (UNII: IY9XDZ35W2)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • MENTHOL (UNII: L7T10EIP3A)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Walgreen Company
Labeler Code: 0363
FDA Application Number: part341 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 11-13-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)

Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]
Guaifenesin

Guaifenesin is pronounced as (gwye fen' e sin)
Why is guaifenesin medication prescribed?
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a cla...
[Read More]

* Please review the disclaimer below.

Wal-tussin Dm Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Otc - Active Ingredient

Active ingredients (in each 10 mL)Dextromethorphan HBr, USP 20 mgGuaifenesin, USP 200 mg

Otc - Purpose

PurposeDextromethorphan HBr, USP .......................Cough SuppressantGuaifenesin, USP ....................................... Expectorant

Indications & Usage

Uses■ temporarily relieves cough due to minor throat and bronchialirritation as may occur with a cold■ helps loosen phlegm (mucus) and thin bronchial secretions todrain bronchial tube

Warnings

Warnings

Otc - Do Not Use

Do not use ■ in a child under 12 years of age■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugsfor depression, psychiatric or emotional conditions or Parkinson's disease), or for 2 weeksafter 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.

Otc - Ask Doctor

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 bronchitisor emphysema

Otc - Stop Use

Stop use and ask adoctor if cough lasts more than 7 days, comes back or isaccompanied by fever, rash or persistent headache. These could be signs of a seriouscondition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a PoisonControl Center right away.

Dosage & Administration

Directions ■ do not take more than 6 doses in any 24-hour period                Age                Dose adults & children 12 years & over    10 mL every 4 hours children under 12 years             do not use

Other Safety Information

Other information■ Keep carton for full Direction for use.■ store at 20-25°C (68-77°F)■ do not refrigerate■ dosage cup provided■ sodium 6 mg per 10 mL

Inactive Ingredient

Inactive ingredientsanhydrous citric acid, dextrose, FD&C red # 40, flavor, glycerin, high fructose corn syrup,menthol, purified water, saccharin sodium, sodium benzoate.

Otc - Questions

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944.

Product Label

WalgreensCompare to Robitussin® PeakCold Cough & Chest CongestionDM active ingredients††                         NDC 0363-0324-28ADULT • NON-DROWSYWal-Tussin®DMCOUGH & CHESTCONGESTIONDEXTROMETHORPHAN HBr /COUGH SUPPRESSANTGUAIFENESIN / EXPECTORANTALCOHOL FREE• Relieves cough &   chest congestion• 12 years & older12 FL OZ (354 mL)ORG1020-F2DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSINGWalgreens Pharmacist Survey††This product is not manufactured or distributed by PF Consumer Healthcare1LLC, owner of the registered trademark Robitussin® Peak Cold.DISTRIBUTED BY WALGREEN CO.200 WILMONT RD., DEERFIELD, IL 60015Walgreens100% SATISFACTION           GUARANTEEDwalgreens.com ©2020 Walgreen Co.DOSAGECUP PROVIDED             BX-112CartonBottleres

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