FDA.reportPublic FDA data

robafen

Manufacturer
A-S Medication Solutions
Effective date
2021-04-16
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:39:44

Label at a glance#

Productrobafen
Active ingredientGUAIFENESIN
Label structure10 sections

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 – 20 mL every 4 hours children under 12 years do not use

Storage and handling

• store at 20-25 ° C (68-77 ° F). Do not refrigerate.

Label contents#

Full prescribing information#

Active ingredient (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin, USP 200 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Use

INDICATIONS & USAGE SECTION

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

WARNINGS SECTION

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 – 20 mL every 4 hours

children under 12 years

do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, caramel, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, maltol, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-616-2471

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-4189

NDC: 50090-4189-0 473 mL in a BOTTLE

Guaifenesin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN5
213155Robafen 200 MG in 10 mL Oral SolutionPSN5
213155guaifenesin 20 MG/ML Oral Solution [Robafen]SBD5
310604guaifenesin 20 MG/ML Oral SolutionSCD5
310604guaifenesin 100 MG per 5 ML Oral SolutionSY5
310604guaifenesin 100 MG per 5 ML Oral SyrupSY5
310604guaifenesin 200 MG per 10 ML Oral SolutionSY5
310604guaifenesin 300 MG per 15 ML Oral SolutionSY5
310604guaifenesin 400 MG per 20 ML Oral SolutionSY5
213155Robafen 100 MG per 5 mL Oral SolutionSY5
213155Robafen 200 MG per 10 mL Oral SolutionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
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
50090-4189-02023-01-30C16284748780-1f386c649-bf64-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Robafen ™ Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4189-0robafen473 mL in 1 BOTTLESOLUTION4735

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4189ROBAFEN (GUAIFENESIN) SOLUTION [A-S MEDICATION SOLUTIONS]5Legacy NDC, 1 package rows20210417_65188fb6-1c0b-4e81-b0f7-af28d2b27b87.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4189-0ML - Milliliter50090-41898c744b94-d64b-4d28-a64f-0c51766e5ce712022-01-06
0904-6763-16ML - Milliliter0904-6763ffd1de6e-9420-4f95-aeae-ee1de667f2d912019-04-11
0904-6763-20ML - Milliliter0904-676388428996-a6a1-479f-9fbd-5d5597d6069712018-12-13

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-418950090-4189-0
0904-6763

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARAMELT9D99G2B1RIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
MALTOL3A9RD92BS4IACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT

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
396f2c58-458c-4d5e-a7a6-49a188253f9e65188fb6-1c0b-4e81-b0f7-af28d2b27b872021-04-16WarningsExact identifier
spl id: 396f2c58-458c-4d5e-a7a6-49a188253f9e
spl set id: 65188fb6-1c0b-4e81-b0f7-af28d2b27b87

Reported adverse events (FAERS/openFDA)#

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