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robafen

Medically reviewed on Feb 8, 2018

Dosage form: syrup
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 20mg in 10mL, GUAIFENESIN 200mg in 10mL
Labeler: Major Pharmaceuticals
NDC Code: 0904-6464

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.

Major Pharmaceuticals Robafen® Drug Facts

Active ingredients (in each 10 mL)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Purposes

Cough suppressant

Expectorant

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

Ask a doctor before use if you have
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (1-800-222-1222).

Directions
do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided
keep dosing cup with product
mL = milliliter
this adult product is not intended for use in children under 12 years of age

age

dose

adults and children 12 years and over

10 mL every 4 hours

children under 12 years

do not use

Other information
each 10 mL contains: sodium 6 mg
store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose

Questions or comments?

1-800-616-2471

Principal Display Panel

ROBAFEN®

DM COUGH & CHEST CONGESTION

COUGH SUPPRESSANT (Dextromethorphan HBr)

EXPECTORANT (Guaifenesin)

PEAK COLD

Relieves:

Cough

Mucus

Non-Drowsy

COMPARE TO the active ingredients of ROBITUSSIN® COUGH + CHEST CONGESTION DM

FOR ADULTS

Ages 12 and Over

4 FL. OZ. (118 mL)

Principal Display Panel

ROBAFEN®

DM COUGH & CHEST CONGESTION

COUGH SUPPRESSANT (Dextromethorphan HBr)

EXPECTORANT (Guaifenesin)

Carton Side 2

ROBAFEN 
dextromethorphan hbr, guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6464
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
MENTHOL, UNSPECIFIED FORM 
SODIUM CITRATE, UNSPECIFIED FORM 
SUCRALOSE 
Product Characteristics
ColorRED (clear) Score    
ShapeSize
FlavorCHERRY (Fruity) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-6464-201 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/15/1991
Labeler - Major Pharmaceuticals (191427277)
Registrant - Major Pharmaceuticals (191427277)

 
Major Pharmaceuticals

Further information

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

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