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Robafen DM Cough Sugar Free Clear

Medically reviewed on September 8, 2017

Dosage form: solution
Ingredients: Guaifenesin 100mg in 5mL, Dextromethorphan Hydrobromide 10mg in 5mL
Labeler: Major Pharmaceuticals
NDC Code: 0904-6306

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Robafen® DM Cough Sugar Free Clear

Drug Facts

Active ingredients (in each 2 teaspoonfuls (10 mL)) Purposes
Dextromethorphan HBr USP 20 mgCough suppressant
Guaifenesin USP 200 mgExpectorant

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
agedose
adults and children 12 years and over2 TSP every 4 hours
children under 12 yearsdo 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

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)

ROBAFEN DM COUGH SUGAR FREE CLEAR 
guaifenesin and dextromethorphan hydrobromide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6306
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Benzoate 
Polyethylene Glycol, Unspecified 
Anhydrous Citric Acid 
Glycerin 
Propylene glycol 
Povidone, Unspecified 
Menthol, Unspecified Form 
Prunus Serotina Bark 
Sucralose 
Water 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-6306-20118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/20/2012
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIOperations
Bio-Pharm, Inc.801652546MANUFACTURE(0904-6306), ANALYSIS(0904-6306), PACK(0904-6306), LABEL(0904-6306)

 
Major Pharmaceuticals

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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