Label: ROBAFEN DM COUGH- dextromethorphan hbr, guaifenesin solution
- NDC Code(s): 0904-7441-20
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 4, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 20 mL)
- Purpose
- 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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
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
ExpectorantOral Solution
• Controls Cough
• Relieves Chest Congestion
• Thins & Loosens MucusAges 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 ORG062307336PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.orgDistributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
www.majorpharmaceuticals.comMajor 44-073
-
INGREDIENTS AND APPEARANCE
ROBAFEN DM COUGH
dextromethorphan hbr, guaifenesin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-7441 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 20 mL Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor MENTHOL, MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-7441-20 1 in 1 CARTON 04/05/2024 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 04/05/2024 Labeler - Major Pharmaceuticals (191427277) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 manufacture(0904-7441) , pack(0904-7441)