NDC 0031-8739 Robitussin Maximum Strength Cough Plus Chest Congestion Dm
Dextromethorphan Hydrobromide, Guaifenesin Solution Oral
Product Information
What is NDC 0031-8739?
The NDC code 0031-8739 is assigned by the FDA to the product Robitussin Maximum Strength Cough Plus Chest Congestion Dm which is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Robitussin Maximum Strength Cough Plus Chest Congestion Dm is dextromethorphan hydrobromide, guaifenesin. The product's dosage form is solution and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 0031-8739-12 1 bottle in 1 carton / 118 ml in 1 bottle, 0031-8739-18 1 bottle in 1 carton / 237 ml in 1 bottle, 0031-8739-42 1 bottle in 1 carton / 355 ml in 1 bottle. 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.
What are the uses for Robitussin Maximum Strength Cough Plus Chest Congestion Dm?
This product is used as Active ingredients (in each 20 ml)PurposesDextromethorphan HBr, USP 20 mgCough suppressantGuaifenesin, USP 400 mgExpectorant. 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
Product Characteristics
Color(s) | RED (C48326) |
Product Packages
NDC Code 0031-8739-12
Package Description: 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
NDC Code 0031-8739-18
Package Description: 1 BOTTLE in 1 CARTON / 237 mL in 1 BOTTLE
NDC Code 0031-8739-42
Package Description: 1 BOTTLE in 1 CARTON / 355 mL in 1 BOTTLE
Product Details
What are Robitussin Maximum Strength Cough Plus Chest Congestion Dm Active Ingredients?
- DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL - 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 400 mg/20mL - An expectorant that also has some muscle relaxing action. It is used in many cough preparations.
Robitussin Maximum Strength Cough Plus Chest Congestion Dm Active Ingredients UNII Codes
- DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH)
- DEXTROMETHORPHAN (UNII: 7355X3ROTS) (Active Moiety)
- GUAIFENESIN (UNII: 495W7451VQ)
- GUAIFENESIN (UNII: 495W7451VQ) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 1020138 - dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution
- RxCUI: 1020138 - dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution
- RxCUI: 1020138 - dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution
- RxCUI: 1020138 - dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution
Robitussin Maximum Strength Cough Plus Chest Congestion Dm Inactive Ingredients UNII Codes
- ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- GLYCERIN (UNII: PDC6A3C0OX)
- DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
- MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
- POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- WATER (UNII: 059QF0KO0R)
- SODIUM BENZOATE (UNII: OJ245FE5EU)
- SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
- SUCRALOSE (UNII: 96K6UQ3ZD4)
- TRIACETIN (UNII: XHX3C3X673)
- XANTHAN GUM (UNII: TTV12P4NEE)
Pharmacologic Class(es)
- Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
- Expectorant - [EPC] (Established Pharmacologic Class)
- Increased Respiratory Secretions - [PE] (Physiologic Effect)
- Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
* Please review the disclaimer below.
Patient Education
Dextromethorphan
Dextromethorphan is pronounced as (dex troe meth or' fan)
Why is dextromethorphan medication prescribed?Guaifenesin
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 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.
Robitussin Maximum Strength Cough Plus Chest Congestion Dm 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
- OTC - PURPOSE
- USES
- OTC - DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE CARTON
Other
Drug Facts
Distributed by:
Pfizer, Madison, NJ 07940 USA
Otc - Purpose
Active ingredients (in each 20 ml) | Purposes |
---|---|
Dextromethorphan HBr, USP 20 mg | Cough suppressant |
Guaifenesin, USP 400 mg | Expectorant |
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Otc - Do Not Use
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
Otc - Stop Use
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.
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.
Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- keep dosing cup with product
- ml = milliliter
- this adult product is not intended for use in children under 12 years of age
age | dose |
---|---|
adults and children 12 years and over | 20 ml every 4 hours |
children under 12 years | do not use |
Other Information
- each 20 ml contains: sodium 12 mg
- store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, menthol, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, triacetin, xanthan gum
Questions Or Comments?
call weekdays from 9 AM to 5 PM EST at 1-800-762-4675
Made in Canada
For most recent product information, visit www.robitussin.com
Principal Display Panel - 118 Ml Bottle Label
ADULT
Robitussin®
MAXIMUM STRENGTH
Cough+Chest
Congestion DM
DM
MAX
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
Non-Drowsy
4 FL OZ (118 ml)
Principal Display Panel - 118 Ml Bottle Carton
See
New
Dosing
ADULT
Robitussin®
MAXIMUM STRENGTH
Cough+Chest
Congestion DM
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
✓ Controls Cough✓ Relieves Chest Congestion✓ Thins & Loosens Mucus
Non-Drowsy
BETTER
TASTING!
Same Effective
Cough Relief*
DM
MAX
For Ages 12 & Over
4 FL OZ (118 ml)
* Please review the disclaimer below.