Robafen Dm Cough Sugar Free Clear (Guaifenesin And Dextromethorphan Hydrobromide) Solution [Atlantic Biologicals Corps] -

ROBAFEN DM COUGH SUGAR FREE CLEAR (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [ATLANTIC BIOLOGICALS CORPS]
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NDC	17856-6306-1, 17856-6306-5
Set ID	ab0f8f18-cce4-41e9-957e-e9396966094a
Category	HUMAN OTC DRUG LABEL
Packager	Atlantic Biologicals Corps
Generic Name
Product Class
Product Number
Application Number	PART341

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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?

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

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

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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