NDC 76140-106 Tussin Dm

NDC Product Code 76140-106

NDC CODE: 76140-106

Proprietary Name: Tussin Dm What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Product Characteristics

Color(s):
RED (C48326)
Flavor(s):
TROPICAL FRUIT PUNCH (C73419)
ORANGE (C73406)
MENTHOL (C73403)

NDC Code Structure

  • 76140 - Davagen Pharmaceutical, Llc

NDC 76140-106-08

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 236 mL in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Tussin Dm with NDC 76140-106 is a product labeled by Davagen Pharmaceutical, Llc. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 996520.

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.

  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SORBITOL (UNII: 506T60A25R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • MENTHOL (UNII: L7T10EIP3A)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

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

Labeler Name: Davagen Pharmaceutical, Llc
Labeler Code: 76140
Start Marketing Date: 04-10-2013 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: 12-31-2017 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

* Please review the disclaimer below.

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.

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

Otc - Purpose

Active ingredients (in each 5 mL tsp):PurposeDextromethorphan HBr, USP 10 mgCough suppressantGuaifenesin, USP 100 mgExpectorant

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.

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.

Otc - Ask Doctor

Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) or a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Other

Do not exceed recommended dose

Manufactured by:davAgenPharmaceutical LLCSomerset, NJ 08873

Otc - Stop Use

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.

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 Poison Control Center right away.

Other Information

Each tsp contains: sodium 6.5 mg. Store at 20°-25°C (68°-77°F), Do not refrigerate. Dosage cup provided.

Inactive Ingredients

Citric acid, FD & C Red # 40, flavor, glycerin, menthol, propylene glycol, purified water, saccharine sodium, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Directions

  • Do not take more than 6 doses in any 24-hour periodthis adult product is not intended for use in children under 12 years of agemL = milliliter; tsp = teaspoonfulagedoseadults and children 12 years and over10 mL (2 tsp) every 4 hourschildren under 12 yearsdo not use

* Please review the disclaimer below.