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NDC 00904-7223-20 robafen dm 20; 200 mg/20mL; mg/20mL Details

robafen dm 20; 200 mg/20mL; mg/20mL

robafen dm is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.

MedlinePlus Drug Summary

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 the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 00904-7223-20
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

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 class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 00904-7223-20
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	00904-7223
Product ID	0904-7223_db18295f-456d-478f-b7fb-dd27aab153be
Associated GPIs
GCN Sequence Number	079414
GCN Sequence Number Description	guaifenesin/dextromethorphan LIQUID 50-5MG/5ML ORAL
HIC3	B3T
HIC3 Description	NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION
GCN	45903
HICL Sequence Number	000223
HICL Sequence Number Description	GUAIFENESIN/DEXTROMETHORPHAN HBR
Brand/Generic	Generic
Proprietary Name	robafen dm
Proprietary Name Suffix	n/a
Non-Proprietary Name	dextromethorphan hydrobromide, guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	20; 200
Active Ingredient Units	mg/20mL; mg/20mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Labeler Name	Major Pharmaceuticals
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Ant
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00904-7223-20 (00904722320)

Pricing Information
NDC Package Code	0904-7223-20
Billing NDC	00904722320
Package	1 BOTTLE in 1 CARTON (0904-7223-20) / 118 mL in 1 BOTTLE
Marketing Start Date	2022-01-07
NDC Exclude Flag	N
Price Per Unit	0.02014
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	ROBAFEN DM 200-20 MG/20 ML LIQ
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 5e19220d-9cf3-4732-b9aa-c09db5d69ce6 Details

Active ingredients (in each 20 mL)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Purposes

Cough suppressant

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

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

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

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).

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 14 mg
•: store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

1-800-616-2471

Package/Label Principal Display Panel

MAJOR®

Compare to Robitussin® Cough + Chest Congestion DM active ingredients

Robafen® DM Cough and Chest Congestion

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Cough Suppressant

Expectorant

Controls Cough

Relieves Chest Congestion

Thins and Loosens Mucus

SEE NEW DOSING

Raspberry Flavor

Non-Drowsy

For Adults Ages 12 and Over

4 FL. OZ. (118 mL)

INGREDIENTS AND APPEARANCE

ROBAFEN DM

dextromethorphan hydrobromide, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-7223
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg in 20 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0904-7223-20	1 in 1 CARTON	01/07/2022
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:0904-7223-59	1 in 1 CARTON	01/24/2022
2		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	01/07/2022

Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2022

Document Id: db18295f-456d-478f-b7fb-dd27aab153be

Set id: 5e19220d-9cf3-4732-b9aa-c09db5d69ce6

Version: 2

Effective Time: 20220124