robafen dm
Major Pharmaceuticals Robafen DM Drug Facts
5b2fd5ce-56ab-491a-81b9-44e35a5d2316
HUMAN OTC DRUG LABEL
Sep 17, 2025
Preferred Pharmaceuticals Inc.
DUNS: 791119022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dextromethorphan hydrobromide, guaifenesin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (12)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Package/Label Principal Display Panel
MAJOR®
Relabeled By: Preferred Pharmaceuticals Inc.
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)
INDICATIONS & USAGE SECTION
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 - ACTIVE INGREDIENT SECTION
Active ingredients (in each 20 mL)
Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg
OTC - PURPOSE SECTION
Purposes
Cough suppressant
Expectorant
WARNINGS SECTION
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).
DOSAGE & ADMINISTRATION SECTION
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 SAFETY INFORMATION
Other information
•
**each 20 mL contains:** sodium 14 mg
•
store at 20-25°C (68-77°F). Do not refrigerate.
INACTIVE INGREDIENT SECTION
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
OTC - QUESTIONS SECTION
Questions or comments?
1-800-616-2471