Indications and 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
Robafen DM Cough Sugar Free Clear
- Manufacturer
- Major Pharmaceuticals
- Effective date
- 2019-09-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:09:41
Label at a glance#
ProductRobafen DM Cough Sugar Free Clear
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections
Dosage and administration
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 age dose adults and children 12 years and over 2 TSP every 4 hours children under 12 years do not use
Storage and handling
each TSP (5mL) contains: sodium 2 mg store at 20-25° C (68-77° F). Do not refrigerate
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients (in each 2 teaspoonfuls (10 mL)) | Purposes |
|---|---|
| Dextromethorphan HBr USP 20 mg | Cough suppressant |
| Guaifenesin USP 200 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
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)
OTC - STOP USE SECTION
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
If pregnant or breast-feeding ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
| age | dose |
|---|---|
| adults and children 12 years and over | 2 TSP every 4 hours |
| children under 12 years | do 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
SPL UNCLASSIFIED SECTION
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)
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6306-20 | ML - Milliliter | 0904-6306 | 5d14d06c-f4e4-41c1-babf-c3e7cf0e3ad1 | 1 | 2014-11-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Dextromethorphan Hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| Guaifenesin | ACTIVE INGREDIENT | 495W7451VQ | 1 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| Guaifenesin | ACTIVE MOIETY | 495W7451VQ | 1 | |
| Anhydrous Citric Acid | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Menthol | INACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| Polyethylene Glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| Povidones | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| Propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| Prunus Serotina Bark | INACTIVE INGREDIENT | 5D48E975HA | 1 | |
| Sodium Benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| Sucralose | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Robafen DM Cough Sugar Free Clear
- Guaifenesin and Dextromethorphan Hydrobromide
- SODIUM BENZOATE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- ANHYDROUS CITRIC ACID
- GLYCERIN
- PROPYLENE GLYCOL
- POVIDONE, UNSPECIFIED
- MENTHOL, UNSPECIFIED FORM
- PRUNUS SEROTINA BARK
- SUCRALOSE
- WATER
- GUAIFENESIN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0904-6306 | 0904-6306-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | IACT |
| PRUNUS SEROTINA BARK | 5D48E975HA | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| WATER | 059QF0KO0R | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / DENTAL | NA | ||
| Povidones | POVIDONE | FZ989GH94E | DROPS / ORAL | NA | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / TOPICAL | 4.35 %w/v | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION/ DROPS / ORAL | 15 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EFFERVESCENT / ORAL | 1080 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET / ORAL | 197 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | TABLET / ORAL | 30 mg | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM / SUBLINGUAL | 11 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, DELAYED RELEASE / ORAL | 1.7 mg | ||
| Povidones | POVIDONE | FZ989GH94E | TABLET / SUBLINGUAL | 6 mg | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | ELIXIR / ORAL | 90 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | POWDER, FOR SOLUTION / ORAL | 414 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | ELIXIR / ORAL | 5.02 mg/5ml | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | TABLET, COATED / ORAL | 0.2 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY / TOPICAL | 0.01 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CREAM, AUGMENTED / TOPICAL | 55 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | SPRAY / NASAL | 2 mg | ||
| Menthol | MENTHOL | L7T10EIP3A | GEL / TOPICAL | 0.1 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | LIQUID / INTRAVENOUS | 18 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM, AUGMENTED / TOPICAL | 8 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | FILM / BUCCAL | 1 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM / BUCCAL | 1.48 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | TABLET, ORALLY DISINTEGRATING / ORAL | 60 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | GRANULE / ORAL | NA | ||
| Povidones | POVIDONE | FZ989GH94E | SUSPENSION / OPHTHALMIC | 1.8 %w/v | ||
| Menthol | MENTHOL | L7T10EIP3A | CONCENTRATE / ORAL | 0.05 mg/5ml | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM, SOLUBLE / ORAL | 7 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAVENOUS | 16624 mg | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / SUBCUTANEOUS | 101 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| Povidones | POVIDONE | FZ989GH94E | TABLET, FOR SUSPENSION / ORAL | 2 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| Povidones | POVIDONE | FZ989GH94E | TABLET, ORALLY DISINTEGRATING / ORAL | 15.03 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | OIL / TOPICAL | 2 mg | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | POWDER, FOR SOLUTION / ORAL | 123 mg | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / OPHTHALMIC | 0.09 %w/v | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET / BUCCAL | 30 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / RECTAL | 904 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 9363c835-c994-159e-e053-2995a90a607b | 128a4887-c311-4455-b2fa-9ed824a50bdc | 2019-09-25 | Warnings | 9363c835-c994-159e-e053-2995a90a607b 128a4887-c311-4455-b2fa-9ed824a50bdc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.