NDC 0121-4809 Guaifenesin Dm

  1. Labeler Index
  2. Pharmaceutical Associates, Inc.
  3. NDC: 0121-4809 Guaifenesin Dm

NDC Product Code 0121-4809

NDC CODE: 0121-4809

Proprietary Name: Guaifenesin 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):
CHERRY (C73375)

NDC Code Structure

NDC 0121-4809-05

Package Description: 4 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE

NDC 0121-4809-10

Package Description: 4 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE

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

NDC Product Information

Guaifenesin Dm with NDC 0121-4809 is product labeled by Pharmaceutical Associates, Inc.. The product's dosage form is and is administered via form.

RxNorm Crosswalk

What is RxNorm?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.

The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:


Product Labeler Information

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

Labeler Name: Pharmaceutical Associates, Inc.
Labeler Code: 0121
Start Marketing Date: 05-17-2010 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".

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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]

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Guaifenesin Dm Product Label Images

Guaifenesin 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

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 bronchial tubes

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

Directions

  • Shake well before usingdo not take more than 6 doses in any 24-hour period agedoseadults and children 12 years and over10 mL (2 teaspoonsful) every 4 hourschildren 6 to under 12 years of age5 mL (1 teaspoonful) every 4 hourschildren 2 to under 6 years of age2.5 mL (1/2 teaspoonful) every 4 hourschildren under 2 yearsconsult a doctor

Other Information

  • Each teaspoonful contains: sodium 4 mgstore at 20° - 25°C (68° - 77°F)alcohol/sugar free red, cherry flavored solution supplied in the following oral dosage forms: NDC 0121-0809-04 (4 fl oz bottle), NDC 0121-0809-08 (8 fl oz bottle), NDC 0121-4809-05 (unit dose cups of 5 mL, packaged in trays of 10), and NDC 0121-4809-10 (unit dose cups of 10 mL, packaged in trays of 10).

Inactive Ingredients

Acesulfame K, citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol and sucralose.

* Please review the disclaimer below.