Indications and 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.
Rabofen DM
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2021-05-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:44:56
Label at a glance#
ProductRabofen DM
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 adult product is not intended for use in children under 12 years of age TSP=teaspoonful adults and children 12 years and over 2 TSP every 4 hours children under 12 years do not use
Storage and handling
each TSP (5 mL) contains: sodium 3 mg store at 20°-25°C (68°-77°F). Do not refrigerate Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing
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 TSP (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 occur 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 an 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 that 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 the 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 adult product is not intended for use in children under 12 years of age
- TSP=teaspoonful
| adults and children 12 years and over | 2 TSP every 4 hours |
| children under 12 years | do not use |
Other information
- each TSP (5 mL) contains: sodium 3 mg
- store at 20°-25°C (68°-77°F). Do not refrigerate
TAMPER-EVIDENT
Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing
Inactive ingredients
artificial cherry flavor, citric acid, corn syrup, FD&C Red #40, glycerin, menthol, purified water, saccharin sodium, sodium benzoate
Questions or comments?
(800)-616-2471
SPL UNCLASSIFIED SECTION
Distributed by:
MAJOR
® PHARMACEUTICALS
17177 N Laurel Park Drive,
Suite 233, Livonia, MI 48152
PRINCIPAL DISPLAY PANEL -
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-4143-4 | 2024-06-04 | C162847 | 48780-1 | ba0f9c33-423f-a910-e053-dadaa90a0b85 | Rabofen™ DM |
| 68071-4143-4 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-423f-a910-e053-dadaa90a0b85 | Rabofen™ DM |
| 68071-4143-4 | 2021-05-12 | C162847 | 48780-1 | ba0f9c33-423f-a910-e053-dadaa90a0b85 | Rabofen™ DM |
| 68071-4143-4 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-423f-a910-e053-dadaa90a0b85 | Rabofen™ DM |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-0053-00 | ML - Milliliter | 0904-0053 | 7d3648b9-4173-4706-b15e-f3bc2efa8c51 | 1 | 2017-11-06 |
| 0904-0053-09 | ML - Milliliter | 0904-0053 | c62f2a5e-307c-4dd3-8b1a-8a0b9ba660a8 | 1 | 2017-11-06 |
| 0904-0053-16 | ML - Milliliter | 0904-0053 | 6683dffc-731f-494b-acdd-ce0d72142d60 | 1 | 2017-11-06 |
| 0904-0053-20 | ML - Milliliter | 0904-0053 | 75c95baa-38ce-4e45-8303-e6b31bbe9a7f | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- Rabofen DM
- Guaifenesin and Dextromethorphan Hydrobromide
- SODIUM BENZOATE
- SACCHARIN SODIUM
- ANHYDROUS CITRIC ACID
- GLYCERIN
- MENTHOL, UNSPECIFIED FORM
- WATER
- CORN SYRUP
- PRUNUS SEROTINA BARK
- FD&C RED NO. 40
- GUAIFENESIN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68071-4143 | 68071-4143-4 |
| 0904-0053 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | IACT |
| WATER | 059QF0KO0R | IACT |
| CORN SYRUP | 9G5L16BK6N | IACT |
| PRUNUS SEROTINA BARK | 5D48E975HA | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
Source Document#
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 |
|---|---|---|---|---|---|---|
| 1a14d15b-a003-c656-e063-6294a90a1de3 | 5cdfdcb3-ea2a-63b9-e053-2a91aa0ae17f | 2024-06-04 | Warnings | 5cdfdcb3-ea2a-63b9-e053-2a91aa0ae17f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.