FDA.reportPublic FDA data

PECGEN DMX

Manufacturer
KRAMER NOVIS
Effective date
2025-11-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:16:46

Label at a glance#

ProductPECGEN DMX
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections

Indications and uses

• suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants. • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive.

Dosage and administration

Take every 4 hours, or as directed by a doctor.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients (in each 5 mL tsp)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, 10 mg

Guaifenesin, 187 mg

Purposes

OTC - PURPOSE SECTION

Antitussive

Expectorant

Uses

INDICATIONS & USAGE SECTION

• suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants.

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages 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)
• a 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
• symptoms do not get better within 7 days or are accompanied by fever
• 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 accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Take every 4 hours, or as directed by a doctor.

DirecDirec

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, flavors, menthol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Other information

STORAGE AND HANDLING SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call weekdays from 8 AM to 4 PM AST at 1-787-767-2072. San Juan, PR 00917
www.kramernovis.com

SPL UNCLASSIFIED SECTION

Contains the same active ingredients as Trispec® DMX*

Sugar, Alcohol, Dye and Gluten FREE

CHERRY RASPBERRY FLAVOR

Manufactured in the USA for Kramer Novis

*Trispec® DMX is a registered trademark of Deliz Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Deliz Pharmaceutical Corp.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pecgen-1Pecgen-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1441364dextromethorphan HBr 10 MG / guaiFENesin 187 MG in 5 mL Oral SolutionPSN5
1441364dextromethorphan hydrobromide 2 MG/ML / guaifenesin 37.4 MG/ML Oral SolutionSCD5
1441364dextromethorphan hydrobromide 10 MG / guaifenesin 187 MG per 5 ML Oral SolutionSY5

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-130352083630163GTIN-13: 0352083630163
EAN-13: 0352083630163
GTIN-12: 352083630163
UPC-A: 352083630163
GTIN storage (14 digits): 00352083630163		Pecgn-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
52083-630-162025-11-18C16284748780-12cef2736-8a63-d83d-e063-dadaa90ab31fPECGEN ® DMX
52083-630-162025-01-30C16284748780-12cef2736-8a63-d83d-e063-dadaa90ab31fPECGEN ® DMX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-630-16PECGEN DMX474 mL in 1 BOTTLE, PLASTICSOLUTION4745

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-630-16ML - Milliliter52083-630d3358e56-bf8e-4654-bb6b-e3acb1fbb97712015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH2
GUAIFENESINACTIVE INGREDIENT495W7451VQ2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS2
GUAIFENESINACTIVE MOIETY495W7451VQ2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3A2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q6212
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD42

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
52083-63052083-630-16

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
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
METHYLPARABENA2I8C7HI9TIACT
POLYETHYLENE GLYCOL 1000U076Q6Q621IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
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 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYETHYLENE GLYCOL 1000POLYETHYLENE GLYCOL 1000U076Q6Q621SOLUTION / ORAL1000 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ASOLUTION / ORAL3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYETHYLENE GLYCOL 1000POLYETHYLENE GLYCOL 1000U076Q6Q621SOLUTION / ORAL1000 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ASOLUTION / ORAL3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / ORAL100 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / ORAL100 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route+dosage form
2 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
PECGEN DMXDEXTROMETHORPHAN HBR, GUAIFENESINKRAMER NOVISa627824c-5e3d-4672-a047-6c801b50b4322025-11-14WarningsExact identifier
ndc (package): 52083-630-16
ndc (product): 52083-630
ndc11 (package): 52083063016
spl id: 73a7e53a-91e6-4f2a-98f0-d73ba7995194
spl set id: a627824c-5e3d-4672-a047-6c801b50b432

Reported adverse events (FAERS/openFDA)#

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