ROBAFEN DM COUGH- dextromethorphan hbr, guaifenesin solution 
Major Pharmaceuticals

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Major 44-073

Active ingredients (in each 20 mL)

Dextromethorphan HBr 20 mg
Guaifenesin 200 mg

Purpose

Cough suppressant
Expectorant

Uses

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)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

cough persists more than 7 days, tends to recur, or is accompanied by a 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

Other information

Inactive ingredients

anhydrous citric acid, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sucralose, xanthan gum

Questions or comments?

1-800-426-9391

Principal display panel

MAJOR®

NDC 0904-7441-20
Compare to the active
ingredients in Robitussin®
Sugar-Free Dye-Free
Cough+Chest Congestion DM*

Sugar Free & Dye Free
Robafen® DM
Cough
Dextromethorphan HBr
Guaifenesin
Cough Suppressant
Expectorant

Oral Solution

• Controls Cough
• Relieves Chest Congestion
• Thins & Loosens Mucus

Ages 12 Years and Over

Cool Mint Flavored

4 FL OZ (118 mL)

TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER CAP
IS BROKEN OR MISSING

*This product is not manufactured or distributed by
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC,
owner of the registered trademark Robitussin® Sugar-Free
Dye-Free Cough+Chest Congestion DM.
50844 ORG062307336

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
www.majorpharmaceuticals.com

Major 44-073

Major 44-073

ROBAFEN DM COUGH 
dextromethorphan hbr, guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7441
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMENTHOL, MINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7441-201 in 1 CARTON04/05/2024
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/05/2024
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305manufacture(0904-7441) , pack(0904-7441)

Revised: 4/2024
Document Id: f839064b-1881-4895-ac1a-ee7147816880
Set id: 7c9660b7-cb00-449b-b65f-aa42d8ce1942
Version: 1
Effective Time: 20240404
 
Major Pharmaceuticals