FDA.reportPublic FDA data

Rabofen DM

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2019-03-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:29:13

Label at a glance#

ProductRabofen DM
Active ingredientGuaifenesin, Dextromethorphan Hydrobromide
Label structure10 sections

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.

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

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

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

  • 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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • each TSP (5 mL) contains: sodium 3 mg
  • store at 20°-25°C (68°-77°F). Do not refrigerate

TAMPER-EVIDENT

SPL UNCLASSIFIED SECTION

Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial cherry flavor, citric acid, corn syrup, FD&C Red #40, glycerin, menthol, purified water, saccharin sodium, sodium benzoate

Questions or comments?

OTC - QUESTIONS SECTION

(800)-616-2471

SPL UNCLASSIFIED SECTION

Distributed by:
MAJOR ® PHARMACEUTICALS
17177 N Laurel Park Drive,
Suite 233, Livonia, MI 48152

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68788-0841-1
TAMPER-EVIDENT

MAJOR ®
PHARMACEUTICALS

ROBAFEN™DM

cough formula
Cough Suppressant
Expectorant

*Compare to active ingredients of
Robitussin ®Cough+Chest Congestion DM

Dextromethorphan HBr, USP 20 mg and
Guaifenesin, USP 200 mg per 10 mL

  • Alcohol free
  • Non-narcotic

4 FL. OZ. (118 mL)

Relabeled By: Preferred Pharmaceuticals Inc.

Robafen DM
Robafen DM

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-0053-00ML - Milliliter0904-00537d3648b9-4173-4706-b15e-f3bc2efa8c5112017-11-06
0904-0053-09ML - Milliliter0904-0053c62f2a5e-307c-4dd3-8b1a-8a0b9ba660a812017-11-06
0904-0053-16ML - Milliliter0904-00536683dffc-731f-494b-acdd-ce0d72142d6012017-11-06
0904-0053-20ML - Milliliter0904-005375c95baa-38ce-4e45-8303-e6b31bbe9a7f12012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-084168788-0841-1
0904-0053

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
Guaifenesin495W7451VQACTIB
Dextromethorphan Hydrobromide9D2RTI9KYHACTIB
Sodium BenzoateOJ245FE5EUIACT
Saccharin SodiumSB8ZUX40TYIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GlycerinPDC6A3C0OXIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
WATER059QF0KO0RIACT
Corn Syrup9G5L16BK6NIACT
PRUNUS SEROTINA BARK5D48E975HAIACT
FD&C Red no. 40WZB9127XOAIACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0ccf414c-a6e1-44ab-9f5d-75ddaa32408988f0dd33-06ba-406f-b7b9-9b71fe69673f2020-09-08WarningsExact identifier
spl set id: 88f0dd33-06ba-406f-b7b9-9b71fe69673f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.