NDC 0904-6844 Guaifenesin And Dextromethorphan Oral Solution

Guaifenesin Dextromethorphan Hydrobromide Oral Solution

NDC Product Code 0904-6844

NDC Code: 0904-6844

Proprietary Name: Guaifenesin And Dextromethorphan Oral Solution 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 Dextromethorphan Hydrobromide Oral Solution 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.

NDC Code Structure

  • 0904 - Major Pharmaceuticals
    • 0904-6844 - Guaifenesin And Dextromethorphan Oral Solution

NDC 0904-6844-70

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

NDC Product Information

Guaifenesin And Dextromethorphan Oral Solution with NDC 0904-6844 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Guaifenesin And Dextromethorphan Oral Solution is guaifenesin dextromethorphan hydrobromide oral solution. The product's dosage form is solution and is administered via oral form.

Labeler Name: Major Pharmaceuticals

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 And Dextromethorphan Oral Solution 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 10 mg/5mL
  • GUAIFENESIN 100 mg/5mL

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.

  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SACCHARIN (UNII: FST467XS7D)
  • SORBITOL (UNII: 506T60A25R)
  • 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: Major Pharmaceuticals
Labeler Code: 0904
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: 09-20-2019 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.

Guaifenesin And Dextromethorphan Oral Solution 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

Guaifenesin Dextromethorphan Hydrobromide 100/10 Mg/5 Ml Cup

NCD 0904-6844-70
Guaifenesin and Detromethorphan Oral Solution100-10 mg/5 mLDelivers 5 mLSee InsertFor Institutional Use OnlyMAJOR® PHARMACEUTICALSLivonia, MI 48152Sugar Free - Alcohol Free

  • Directionsdo not exceed the maximum recommended daily dose in a 24 hour periodshake well before useAge (yr)Dose (mL)adults and children 12 years and over10 mL every 4 hours or 15 mL every 6 hoursMax dose is 60 mL in 24 hrchildren 6 years to under 12 years5 mL every 4 hoursMax does is 30 mL in 24 hrunder 6 yearsAsk a doctor

Guaifenesin Dextromethorphan Hydrobromide 100/10 Mg/5 Ml

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


  • WarningsDo not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug.
  • Ask a doctor before use if you havecough that occurs with too much phlegm (mucus)cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema_________________________________________________________________Ask a doctor or pharmacist before use if you are taking any other drug.
  • ___________________________________________________________________Stop use and ask a doctor if your cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.

Active ingredients (in each 5 mL cup) Guaifenesin 100 mgDextromethorphan hydrobromide 10 mg

PurposeExpectorantCough Suppressant

Guaifenesin Dextromethorphan Hydrobromide 100/10 Mg/ 5 Ml

Inactive ingredients citric acid, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, sucralose, xanthan gum

  • Uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productivetemporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

  • Other informationeach 5 mL contains: sodium 20 mgstore at 20-25°C (68-77°F) protect from excessive moisturedo not use if lid seal is open or damaged sugar free, dye free, alcohol free see bottom of cup for lot number and expiration date

Guaifenesin Dextromethorphan Hydrobromide 200/20 Mg/10Ml

NCD 0904-6980-72
Guaifenesin and Detromethorphan Oral Solution200-20 mg/10 mLDelivers 10 mLSee InsertFor Institutional Use OnlyMAJOR® PHARMACEUTICALSLivonia, MI 48152Sugar Free - Alcohol Free

Guaifenesin Dextromethorphan Hydrobromide 200/20 Mg/ 10 Ml

  • Directionsdo not exceed the maximum recommended daily dose in a 24 hour periodshake well before useAge (yr)Dose (mL)adults and children 12 years and over10 mL every 4 hoursMax dose is 60 mL in 24 hrchildren under 12 yearsAsk a doctor

Purpose ExpectorantCough Suppressant

  • Other informationeach 10 mL contains: sodium 40 mgstore at 20-25°C (68-77°F) protect from excessive moisturedo not use if lid seal is open or damaged sugar free, dye free, alcohol free see bottom of cup for lot number and expiration date

Guaifenesin Dextromethorphan Hydrobromide 200/20 Mg/10 Ml

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

  • WarningsDo not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug.
  • Ask a doctor before use if you havecough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema_________________________________________________________________Ask a doctor or pharmacist before use if you are taking any other drug.
  • ___________________________________________________________________Stop use and ask a doctor if your cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. you are hypersensitive to any of the ingredients___________________________________________________________________If pregnant or breast-feeding, ask a health professional before use.

  • Useshelps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Active ingredients (in each 10 mL cup) Guaifenesin 200 mgDextromethorphan hydrobromide 20 mg

Guaifenesin Dextromethorpan Hydrobromide 200/20 Mg/10 Ml

Inactive ingredients citric acid, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, sucralose, xanthan gum

* Please review the disclaimer below.