ROBAFEN DM PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM

Manufacturer
Major Pharmaceuticals | Aurohealth LLC
Effective date
2020-11-27
Label type
Human OTC Drug Label
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:04:23

Label at a glance#

ProductROBAFEN DM PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure13 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 (12 tsp) 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

each 10 mL contains: sodium 6 mg store at 20-25°C (68-77°F). Do not refrigerate alcohol-free

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

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 more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs 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 (12 tsp) 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

  • each 10 mL contains: sodium 6 mg
  • store at 20-25°C (68-77°F). Do not refrigerate
  • alcohol-free

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, flavors, glycerin, hydroxyethyl cellulose, menthol, methylparaben, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate


Questions or comments

OTC - QUESTIONS SECTION

1-800-616-2471

Distributed by: MAJOR®


PHARMACEUTICALS
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152
Rev. 10/19 M-165 Re-order No. 701197


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-7013-20

Compare to the
active ingredients in
Adult Robitussin® Peak Cold
Sugar-Free & Dye-Free
Cough + Chest Congestion DM*

Adult
Robafen™ DM
Peak Cold

Sugar-Free Cough +
Chest Congestion
Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg
Cough Suppressant/Expectorant

20 mg/200 mg

  • Relieves Cough, Mucus
  • Specially formulated for diabetics
  • For ages 12 and over
  • Dye-Free
  • Non-Drowsy
  • Cherry Flavor

4 FL OZ (118 mL)


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7013-20ML - Milliliter0904-7013926c554f-ada7-48b0-aab2-1a59ead7b30612020-01-03

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-70130904-7013-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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
db2ee89a-6cd8-40ce-9614-e2eae9fd79c3ef4ec5c0-7948-465b-8964-088e4db770902020-11-27WarningsExact identifier
spl id: db2ee89a-6cd8-40ce-9614-e2eae9fd79c3
spl set id: ef4ec5c0-7948-465b-8964-088e4db77090

Reported adverse events (FAERS/openFDA)#

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