Robafen dm cough sugar free clear solution

Otc - active ingredient section

Otc - purpose section

(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

Otc - do not use section

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.

Otc - pregnancy or breast feeding section

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

Otc - keep out of reach of children section

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 ®

Ingredients and appearance - Product information

Robafen dm cough sugar free clear solution- Guaifenesin and dextromethorphan hydrobromide

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 17856-6306
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 100 mgin 5 mL
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 10 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
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

Flavor CHERRY

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 17856-6306-5 5mL in 1 CUP 2015/05/05
2 NDC: 17856-6306-1 10mL in 1 CUP 2015/05/05

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA 2015/05/05

Labeler - Atlantic Biologicals Corps( 047437707)

Establishment

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

Robafen dm cough sugar free clear (guaifenesin and dextromethorphan hydrobromide) solution