FDA.reportPublic FDA data

Sorbugen

Manufacturer
Kramer Novis
Effective date
2025-11-12
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:16:47

Label at a glance#

ProductSorbugen
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 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 rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive

Dosage and administration

 • do not take more than 6 doses in any 24-hour period.  • mL = milliliter  • tsp = teaspoon  age  dose  Adults and children 12 years of age and over  2 teaspoonfuls (10 mL) every 4 hours  Children under 12 years of age  Consult a physician

Storage and handling

Tamper evident feature: Do not use if printed security seal is torn, broken or missing. Store at controlled room temperature 15-30°C (59-86°F). Avoid excessive heat or humidity.

Label contents#

Full prescribing information#

Active Ingredients (in each 7.5 mL, 1 ½ teaspoon)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, 15 mg
Guaifenesin (Glyceryl Guaiacolate), 150mg

Purposes

OTC - PURPOSE SECTION

Antitussive
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 rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive

Warnings

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

When using this product, do not use more than directed.

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.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of 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.
 • mL = milliliter
 • tsp = teaspoon

 age dose
 Adults and children 12 years
of age and over		 2 teaspoonfuls (10 mL)
every 4 hours
 Children under 12 years of age Consult a physician

Other information

STORAGE AND HANDLING SECTION

  • Tamper evident feature: Do not use if printed security seal is torn, broken or missing.
  • Store at controlled room temperature 15-30°C (59-86°F).
  • Avoid excessive heat or humidity.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol, sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

1-787-767-2072 You may also report serious side effects to this phone number. Call weekdays from 8AM to 4PM AST

SPL UNCLASSIFIED SECTION

Contains the same active ingredients as Sorbutuss® NR*

Dextromethorphan HBr
ANTITUSSIVE
Guaifenesin (Glyceryl Guaiacolate)
EXPECTORANT

Antihistamine & Decongestant Free

​SUGAR, DYE & ALCOHOL FREE

GRAPE FLAVOR

KramerNovis
Pharmaceuticals within reach of patients

Manufactured in USA with imported ingredients for Kramer Novis,
San Juan, PR 00917.
www.kramernovis.com

*Sorbutuss® NR is a registered trademark of Teral, Inc. 
This product is not manufactured, distributed or marketed by Teral, Inc.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SorbugenSorbugen

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN7
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD7
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY7
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY7
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY7

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130352083660160GTIN-13: 0352083660160
EAN-13: 0352083660160
GTIN-12: 352083660160
UPC-A: 352083660160
GTIN storage (14 digits): 00352083660160		52083660-1.jpg

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
52083-660-162025-11-18C16284748780-12cef2736-ab86-d83d-e063-dadaa90ab31fSORBUGEN ® NR
52083-660-162025-01-30C16284748780-12cef2736-ab86-d83d-e063-dadaa90ab31fSORBUGEN ® NR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-660-16Sorbugen480 mL in 1 BOTTLESYRUP4807

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-660-16ML - Milliliter52083-660b5276731-56be-48f8-b688-1537491875bf12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH2
GUAIFENESINACTIVE INGREDIENT495W7451VQ2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS2
GUAIFENESINACTIVE MOIETY495W7451VQ2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FF2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ42
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD42
WATERINACTIVE INGREDIENT059QF0KO0R2

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
52083-66052083-660-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POTASSIUM CITRATEPOTASSIUM CITRATEEE90ONI6FFSOLUTION / ORAL913 mgExact identifier — unii+route
6 equally ranked IID candidates
POTASSIUM CITRATEPOTASSIUM CITRATEEE90ONI6FFSOLUTION / ORAL913 mgExact identifier — unii+route
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POTASSIUM CITRATEPOTASSIUM CITRATEEE90ONI6FFSUSPENSION / ORALNAExact identifier — unii+route
6 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SYRUP / ORAL2 mg/1mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYRUP / ORAL40 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SYRUP / ORAL2 mg/1mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POTASSIUM CITRATEPOTASSIUM CITRATEEE90ONI6FFPOWDER, FOR SOLUTION / ORAL570 mgExact identifier — unii+route
6 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYRUP / ORAL40 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POTASSIUM CITRATEPOTASSIUM CITRATEEE90ONI6FFPOWDER, FOR SOLUTION / ORAL570 mgExact identifier — unii+route
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POTASSIUM CITRATEPOTASSIUM CITRATEEE90ONI6FFSUSPENSION / ORALNAExact identifier — unii+route
6 equally ranked IID candidates

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
SorbugenDEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATEKramer Novisa8f2a2d7-0360-45a8-9635-c852f4a7d7ba2025-11-12WarningsExact identifier
ndc (package): 52083-660-16
ndc (product): 52083-660
ndc11 (package): 52083066016
spl id: 796f9d98-f855-437f-9bca-bb322fa5b063
spl set id: a8f2a2d7-0360-45a8-9635-c852f4a7d7ba

Reported adverse events (FAERS/openFDA)#

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