FDA.reportPublic FDA data

robafen dm

Manufacturer
Major Pharmaceuticals
Effective date
2018-11-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:45:10

Label at a glance#

Productrobafen dm
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 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 • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 10 mL every 4 hours children under 12 years do not use

Storage and handling

• Phenylketonurics: Contains Phenylalanine 30 mg per 10 mL • store at 20-25°C (68-77°F). Do not refrigerate.

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant

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

Do not use

OTC - DO NOT USE SECTION

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 occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age

age

dose

adults and children

12 years and over

10 mL

every 4 hours

children under 12 years

do not use

Other information

STORAGE AND HANDLING SECTION

  • Phenylketonurics:Contains Phenylalanine 30 mg per 10 mL
  • store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aspartame, benzoic acid, flavor, glycerin, hydroxyethyl cellulose, menthol, polyethylene glycol, purified water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-616-2471

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ROBAFEN® DM COUGH

SUGAR-FREE

CLEAR

COUGH SUPPRESSANT (Dextromethorphan HBr)

EXPECTORANT (Guaifenesin)

Relieves:

Cough

Chest Congestion

Non-Drowsy

Specially Formulated For DIABETICS

COMPARE TO the active ingredients of ROBITUSSIN® SUGAR-FREE COUGH + CONGESTION DM

FOR ADULTS

Ages 12 and Over

4 FL. OZ. (118 mL)

robafen dm image
robafen dm image

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6759-20ML - Milliliter0904-675940ad307b-05fb-4193-a647-d7015f29346a12018-12-13

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-67590904-6759-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
ASPARTAMEZ0H242BBR1IACT
BENZOIC ACID8SKN0B0MIMIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AIACT

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
d14a3ff3-45a9-4b33-aeeb-af50f9644ccb7057ef34-acd9-48e7-ba9f-3446dbc4dc562024-10-31WarningsExact identifier
spl set id: 7057ef34-acd9-48e7-ba9f-3446dbc4dc56

Reported adverse events (FAERS/openFDA)#

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