NDC 0121-2232 Guaifenesin

Guaifenesin

NDC Product Code 0121-2232

NDC CODE: 0121-2232

Proprietary Name: Guaifenesin 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.

Non-Proprietary Name: Guaifenesin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Guaifenesin is used to treat coughs and congestion caused by the common cold, bronchitis, and other breathing illnesses. This product is usually not used for ongoing cough from smoking or long-term breathing problems (such as chronic bronchitis, emphysema) unless directed by your doctor. Guaifenesin is an expectorant. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier. If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you. (See also Precautions section.) Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold. To decrease the risk for side effects, carefully follow all dosage directions. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

NDC Code Structure

  • 0121 - Pharmaceutical Associates, Inc.

NDC 0121-2232-00

Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE (0121-2232-15)

NDC Product Information

Guaifenesin with NDC 0121-2232 is a a human over the counter drug product labeled by Pharmaceutical Associates, Inc.. The generic name of Guaifenesin is guaifenesin. The product's dosage form is solution and is administered via oral form.

Labeler Name: Pharmaceutical Associates, Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Guaifenesin 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.

  • GUAIFENESIN 300 mg/15mL

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.

  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

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.
  • 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: Pharmaceutical Associates, Inc.
Labeler Code: 0121
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: 09-01-2002 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’.

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Information for Patients

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 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

Expectorant


SUGAR FREE / ALCOHOL FREE

Description

Each 5 mL (1 teaspoonful) contains:


Guaifenesin 100 mg

Inactive Ingredients

Acesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40, flavoring, hydroxyethylcellulose, purified water, sodium benzoate and sodium citrate.Sodium Content: 4 mg/5 mL

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

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.you are hypersensitive to any of the ingredients.

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.

Professional Note

Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

Directions

  • Follow dosage below or use as directed by a physician.do not take more than 6 doses in any 24-hour period.agedoseadults and children 12 years and over10 to 20 mL
  • (2 to 4 teaspoonfuls)
  • Every 4 hours
  • Children 6 years to under 12 years5 to 10 mL
  • (1 to 2 teaspoonfuls)
  • Every 4 hours
  • Children 2 to under 6 years of age2.5 to 5 mL
  • (½ to 1 teaspoonful)
  • Every 4 hours
  • Children under 2 years of ageconsult a physician

Storage

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.

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