NDC 58805-007 Cough And Congestion Dm

NDC Product Code 58805-007

NDC CODE: 58805-007

Proprietary Name: Cough And Congestion 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 - LIGHT)
Shape: OVAL (C48345)
Size(s):
20 MM
Imprint(s):
601
Score: 1

NDC Code Structure

  • 58805 - Agile Pharmachem

NDC 58805-007-75

Package Description: 7500 CARTON in 1 CAPSULE > 1 CAPSULE, LIQUID FILLED in 1 CARTON

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

NDC Product Information

Cough And Congestion Dm with NDC 58805-007 is a product labeled by Agile Pharmachem. 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: 1111663.

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.

  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
  • POVIDONE (UNII: FZ989GH94E)
  • POVIDONE K30 (UNII: U725QWY32X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Labeler Information

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

Labeler Name: Agile Pharmachem
Labeler Code: 58805
Start Marketing Date: 11-08-2015 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: 12-31-2019 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.

Cough And Congestion Dm Product Label Images

Cough And Congestion 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

Active Ingredient

(in each liquid filled capsule) Dextromethorphan Hydrobromide, USP 10mgGuaifenesin, USP 200mg

Purpose

Cough SuppressantExpectorant

Uses

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

Directions

  • Do not take more than 12 capsules in any 24 hour periodThis adult product is not intend for use in children under 12 years of age                           Age              doseAdults and children 12 years and over2 capsules every 4 hoursChildren under 12 yearsDo not use

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 havecough that occurs with too much phlegm(mucus)cough that lasts or is chronic such as occur with smoking, asthma, chronic bronchitis, or emphysemaStop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. This 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 right away.

Other Information

  • Store at 20-25 °C(68-77 °F)avoid excessive heat above 40 °C (104°F)

Inactive Ingredients

FD&C Red No 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, providone (PVP K-30), purified water, special sorbitol, titanium dioxide

* Please review the disclaimer below.