ROBAFEN DM COUGH SUGAR FREE CLEAR- guaifenesin and dextromethorphan hydrobromide solution

Robafen DM Cough Sugar Free Clear by

Drug Labeling and Warnings

Robafen DM Cough Sugar Free Clear by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 2 teaspoonfuls (10 mL))	Purposes
Dextromethorphan HBr USP 20 mg	Cough suppressant
Guaifenesin USP 200 mg	Expectorant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occour 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 MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough occurs with too much phlegm (mucus)

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.

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.

Directions

• do not take more than 6 doses in any 24-hour period
• use enclosed dosing cup only. Do not use any other device
• this product is not intended for use in children under 12 years of age
• TSP = teaspoonful

age	dose
adults and children 12 years and over	2 TSP every 4 hours
children under 12 years	do not use

Other information

• each TSP (5mL) contains: sodium 2 mg
• store at 20-25° C (68-77° F). Do not refrigerate

Inactive ingredients

artificial flavor, citric acid, glycerin, menthol, polyethylene glycol 1450, povidone, propylene glycol, purified water, sodium benzoate, sucralose.

Questions or comments?

1-800-616-2471

SPL UNCLASSIFIED SECTION

Distributed by:
MAJOR ® PHARMACEUTICALS
17177 N Laurel Park Drive,
Suite 233
Livonia, MI 48152 USA

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC: 0904-6306-20

MAJOR ®

ROBAFEN ®
DM
COUGH
SUGAR-FREE

CLEAR

COUGH SUPPRESSANT (Dextromethorphan HBr)
EXPECTORANT (Guaifenesin)

Relieves:
■ Cough    ■ Chest Congestion

Non-Drowsy
FOR AGES 12 AND OVER

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

ROBAFEN DM COUGH SUGAR FREE CLEAR 
guaifenesin and dextromethorphan hydrobromide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6306
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PRUNUS SEROTINA BARK (UNII: 5D48E975HA)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6306-20	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2012	04/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/20/2012	04/30/2020

Labeler - Major Pharmaceuticals (191427277)