NDC 46994-385 Tussin Dm Cough And Chest Congestion

Dextromethorphan Hbr, Guaifenesin

NDC Product Code 46994-385

NDC 46994-385-04

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 118 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Tussin Dm Cough And Chest Congestion with NDC 46994-385 is a a human over the counter drug product labeled by Being Well. The generic name of Tussin Dm Cough And Chest Congestion is dextromethorphan hbr, guaifenesin. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Being Well

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.

Tussin Dm Cough And Chest Congestion 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)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • DEXTROSE (UNII: IY9XDZ35W2)
  • 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: Being Well
Labeler Code: 46994
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: 08-30-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Tussin Dm Cough And Chest Congestion 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

Active Ingredients (In Each 10 Ml)

Dextromethorphan HBr 20 mgGuaifenesin 200 mg

Purposes

Cough suppressantExpectorant

Uses

  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a coldhelps loosen phlegm (mucus) and thin bronchial secretions to drain bronchitis tubes

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 more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • Do not take more than 6 doses in any 24-hour period
  • Measure only with dosing cup provided. Do not use any other dosing device.keep dosing cup with productmL = milliliter
  • This adult product is not intended for use in children under 12 years of age
  • Adult and children 12 years and over: 10 mL every 4 hours
  • Children under 12 years : do not use

Other Information

  • Store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive Ingredients

Citric acid, FD&C red #40, flavor, glucose, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Package Label

BEING WELL Adult Cough & Chest Congestion DM

* Please review the disclaimer below.