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 Atlantic Biologicals Corps. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

(in each TSP (5 mL)) Active ingredients	Purpose
Dextromethorphan HBr USP 10 mg	Cough suppressant
Guaifenesin USP 100 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

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinsons 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. Do not use:

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.

ask a health professional before use. If pregnant or breast feeding:

In case of overdose , get medical help or contact a Poison Control center right away. Keep out of reach of children.

Directions

Do not take more than 6 doses in any 24 hour period.

age	dose
Adults and children 12 years and over	2 TSP (teaspoonful) every 4 hours
children under 12 years	do not use

Other information

• sodium- 2mg Each TSP (5ml) contains:
• Store at 20-25° C (68-77° F)
• Dosage cup provided

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: 31778 Enterprise Drive Livonia, MI 48150 USA
MAJOR PHARMACEUTICALS ®

ROBAFEN DM COUGH SUGAR FREE CLEAR (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION

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: 17856-6306(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 Glycols (UNII: 3WJQ0SDW1A)
Anhydrous Citric Acid (UNII: XF417D3PSL)
Glycerin (UNII: PDC6A3C0OX)
Propylene glycol (UNII: 6DC9Q167V3)
Povidones (UNII: FZ989GH94E)
Menthol (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: 17856-6306-5	5 mL in 1 CUP; Type 0: Not a Combination Product	05/05/2015
2	NDC: 17856-6306-1	10 mL in 1 CUP; Type 0: Not a Combination Product	05/05/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/20/2012

Labeler - Atlantic Biologicals Corps (047437707)

Registrant - Atlantic Biologicals Corps (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
Atlantic Biologicals Corps		047437707	RELABEL(17856-6306) , REPACK(17856-6306)