Robafen DM Cough Sugar Free Clear

Manufacturer
Atlantic Biologicals Corps
Effective date
2016-07-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:46:36

Label at a glance#

ProductRobafen DM Cough Sugar Free Clear
Active ingredientGuaifenesin, Dextromethorphan Hydrobromide
Label structure9 sections

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.

Dosage and administration

Do not take more than 6 doses in any 24 hour period. age dose Adults and children 12 years and over 2 TSP (teaspoonful) every 4 hours children under 12 years do not use

Storage and handling

sodium- 2mg Each TSP (5ml) contains: Store at 20-25° C (68-77° F) Dosage cup provided

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

(in each TSP (5 mL)) Active ingredients Purpose
Dextromethorphan HBr USP 10 mgCough suppressant
Guaifenesin USP 100 mgExpectorant

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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 Parkinsons 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. Do not use:

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 occurs with too much phlegm (mucus)

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. If pregnant or breast feeding:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose , get medical help or contact a Poison Control center right away. Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not take more than 6 doses in any 24 hour period.

agedose
Adults and children 12 years and over2 TSP (teaspoonful) every 4 hours
children under 12 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • sodium- 2mg Each TSP (5ml) contains:
  • Store at 20-25° C (68-77° F)
  • Dosage cup provided

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial flavor, citric acid, glycerin, menthol, polyethylene glycol 1450, povidone, propylene glycol, purified water, sodium benzoate, sucralose.

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-616-2471

SPL UNCLASSIFIED SECTION

Distributed by: 31778 Enterprise Drive Livonia, MI 48150 USA
MAJOR PHARMACEUTICALS ®

ROBAFEN DM COUGH SUGAR FREE CLEAR (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN3
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD3
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY3
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY3
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-6306-12020-01-31C16284748780-19d75b9d0-4c96-f424-e053-dadaa90a57ceRobafen DM Cough Sugar Free Clear ®
17856-6306-52020-01-31C16284748780-19d75b9d0-4c96-f424-e053-dadaa90a57ceRobafen DM Cough Sugar Free Clear ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-6306-1Robafen DM Cough Sugar Free Clear10 mL in 1 CUPSOLUTION103
17856-6306-5Robafen DM Cough Sugar Free Clear5 mL in 1 CUPSOLUTION53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-6306ROBAFEN DM COUGH SUGAR FREE CLEAR (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [ATLANTIC BIOLOGICALS CORPS]3Legacy NDC, 2 package rows20160722_ab0f8f18-cce4-41e9-957e-e9396966094a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-6306-5ML - Milliliter17856-6306b4c004d5-826d-47b9-b404-71bff4d77b2f12016-05-16
0904-6306-20ML - Milliliter0904-63065d14d06c-f4e4-41c1-babf-c3e7cf0e3ad112014-11-05

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17856-630617856-6306-5, 17856-6306-1
0904-6306

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
a7dc60f8-6b87-42c8-9163-26db09d1d72cab0f8f18-cce4-41e9-957e-e9396966094a2016-07-22WarningsExact identifier
spl id: a7dc60f8-6b87-42c8-9163-26db09d1d72c
spl set id: ab0f8f18-cce4-41e9-957e-e9396966094a

Reported adverse events (FAERS/openFDA)#

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