FDA.reportPublic FDA data

Rabofen DM

Manufacturer
A-S Medication Solutions
Effective date
2020-01-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:03:17

Label at a glance#

ProductRabofen DM
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure11 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 mgCough suppressant
Guaifenesin, USP 200 mgExpectorant

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 over2 TSP every 4 hours
children under 12 yearsdo 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

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-2657

NDC: 50090-2657-0 118 mL in a BOTTLE

Dextromethorphan Hydrobromide and GUAIFENESIN

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 SolutionPSN5
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD5
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY5
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY5
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY5

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
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2657-02023-01-30C16284748780-1f386c649-bd33-0266-e053-dadaa90a7c1aRabofen™ DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2657-0Rabofen DM118 mL in 1 BOTTLESOLUTION1185

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2657RABOFEN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [A-S MEDICATION SOLUTIONS]5Legacy NDC, 1 package rows20200121_2ed83edb-d48e-4958-adc9-0c9092dd8ec5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2657-0ML - Milliliter50090-26570aea32fa-a9b2-48b7-97de-ecb73c41058112018-12-13
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
50090-265750090-2657-0
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
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
WATER059QF0KO0RIACT
CORN SYRUP9G5L16BK6NIACT
PRUNUS SEROTINA BARK5D48E975HAIACT
FD&C RED NO. 40WZB9127XOAIACT
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

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
2bb4ddb9-c0c1-4c93-9d0e-c96cb23c378c2ed83edb-d48e-4958-adc9-0c9092dd8ec52020-01-18WarningsExact identifier
spl id: 2bb4ddb9-c0c1-4c93-9d0e-c96cb23c378c
spl set id: 2ed83edb-d48e-4958-adc9-0c9092dd8ec5

Reported adverse events (FAERS/openFDA)#

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