NDC 0031-8765 Robitussin Maximum Strength 12 Hour Cough And Mucus Relief
Dextromethorphan Hydrobromide, Guaifenesin Tablet, Extended Release Oral

Product Information

What is NDC 0031-8765?

The NDC code 0031-8765 is assigned by the FDA to the product Robitussin Maximum Strength 12 Hour Cough And Mucus Relief which is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Robitussin Maximum Strength 12 Hour Cough And Mucus Relief is dextromethorphan hydrobromide, guaifenesin. The product's dosage form is tablet, extended release and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 0031-8765-04 1 blister pack in 1 carton / 4 tablet, extended release in 1 blister pack, 0031-8765-08 1 blister pack in 1 carton / 8 tablet, extended release in 1 blister pack, 0031-8765-16 2 blister pack in 1 carton / 8 tablet, extended release in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0031-8765
Proprietary Name 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.
Robitussin Maximum Strength 12 Hour Cough And Mucus Relief
Non-Proprietary Name 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.
Dextromethorphan Hydrobromide, Guaifenesin
Product Type 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.
Human Otc Drug
Dosage FormTablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
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.
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code0031
FDA Application Number 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.
ANDA207602
Marketing Category 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.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
06-14-2019
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Robitussin Maximum Strength 12 Hour Cough And Mucus Relief?


Product Characteristics

Color(s)YELLOW (C48330)
ShapeOVAL (C48345)
Size(s)22 MM
Imprint(s)2424
Score1

Product Packages

NDC Code 0031-8765-04

Package Description: 1 BLISTER PACK in 1 CARTON / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

NDC Code 0031-8765-08

Package Description: 1 BLISTER PACK in 1 CARTON / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

NDC Code 0031-8765-16

Package Description: 2 BLISTER PACK in 1 CARTON / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Product Details

What are Robitussin Maximum Strength 12 Hour Cough And Mucus Relief Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • DEXTROMETHORPHAN HYDROBROMIDE 60 mg/1 - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
  • GUAIFENESIN 1200 mg/1 - An expectorant that also has some muscle relaxing action. It is used in many cough preparations.

Robitussin Maximum Strength 12 Hour Cough And Mucus Relief Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1099074 - guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1099074 - 12 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral Tablet
  • RxCUI: 1099074 - dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral Tablet

Robitussin Maximum Strength 12 Hour Cough And Mucus Relief Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Robitussin Maximum Strength 12 Hour Cough And Mucus Relief Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



Drug Facts

Distributed by: Pfizer, Madison, NJ 07940 USA


Otc - Purpose



Active ingredients (in each extended-release tablet)Purposes
Dextromethorphan HBr 60 mgCough suppressant
Guaifenesin 1200 mgExpectorant

Indications & Usage



Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep

Warnings



Warnings


Do Not Use



  • for children under 12 years of age
  • 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



  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

When Using This Product



  • do not use more than directed

Stop Use And Ask A Doctor If



  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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 (1-800-222-1222).


Dosage & Administration



Directions

  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
  • children under 12 years of age: do not use

Storage And Handling



Other information

  • each tablet contains: magnesium 25 mg
  • store between 20-25°C (68-77°F)

Inactive Ingredient



Inactive ingredients

carbomer homopolymer type B, copovidone, D&C yellow #10 aluminum lake, hypromellose, magnesium hydroxide, magnesium stearate, microcrystalline cellulose, silicon dioxide


Otc - Questions



Questions?

call weekdays from 9 AM to 5 PM EST at 1-800-762-4675


Principal Display Panel - 1200 Mg/60 Mg Tablet Blister Pack



PUSH TABLET THROUGH FOIL

Robitussin® Maximum Strength
12 Hour Cough & Mucus Relief
Extended-Release Tablet

Guaifenesin 1200 mg
Dextromethorphan HBr 60 mg
Extended-Release Tablet

Dist. by: Pfizer, Madison, NJ 07940 USA
©2019 Pfizer Inc.

LOT
EXP


Principal Display Panel - 8 Tablet Blister Pack Carton



NEW!

Robitussin®

MAXIMUM STRENGTH
12 Hour
Cough & Mucus Relief
EXTENDED-RELEASE TABLETS

GUAIFENESIN & DEXTROMETHORPHAN HYDROBROMIDE
1200 mg/60 mg EXTENDED-RELEASE TABLETS

Expectorant & Cough Suppressant

Actual Size

✓Controls Cough

✓Thins & Loosens Mucus

8
EXTENDED-RELEASE TABLETS


* Please review the disclaimer below.