Rompe Pecho

Manufacturer
Efficient Laboratories Inc
Effective date
2025-10-14
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
full-release
Hydrated at
2026-06-01 01:38:59

Label at a glance#

ProductRompe Pecho DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:(in each teaspoonful 5 ml.)                                Purpose

Dextromethorphan Hydrobromide 10 mg ...................................... Cough Suppressant

Guaifenesin 100 mg ................................................................... Expectorant

OTC - PURPOSE SECTION

Purpose

Cough Suppressant

Expectorant

INDICATIONS & USAGE SECTION

Uses:

  • temporarily relieves cough as may occur with the common cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus.

WARNINGS SECTION

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if you have

  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

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 on MAOI, ask a doctor or pharmacist before taking this product.  
  • Stop use and ask a doctor
  • If cough persists more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign 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 reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Shake well before use

Do not exceed more than 6 doses in any 24 hour period or as directed by a doctor

Age                                                                             Dose

Adults and Children 12 years of age and over              10 mL (2 tsps.) every 4 hours

Children 6 to under 12 years of age                            5 mL (1 tsp.) every 4 hours

Children under 6 years of age                                     Do not use

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Blue Cohosh root extract, Echinacea root extract, Eucalyptus oil, Gingka Biloba leaf extract, glycerin, Golden Seal Root extract, Honey, Licorice Root extract, Menthol, Methylparaben, Mullein leaf extract, Myrrh gum extract, Pleurisy Root, Potassium sorbate, polysorbate 80, propolis extract, propylene glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Spearmint flavor, Sucralose, water, Wild Cherry Bark extract and Zinc Sulfate.

OTC - QUESTIONS SECTION

Questions or Comments?

305-805-3456 Monday - Friday 9AM to 5PM EST

www.efficientlabs.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

boxbox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN17
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD17
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY17
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY17
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY17

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
QR code linkQR Codewww.efficientlabs.com/22-6873 Efficient Labs PDF PROOF DM(done).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
58593-275-042023-08-03C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-042023-08-03C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-062023-08-03C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-062023-08-03C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-082023-08-03C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-082023-08-03C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-102023-08-03C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-102023-08-03C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-042023-07-28C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-042023-07-28C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-062023-07-28C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-062023-07-28C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-082023-07-28C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-082023-07-28C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-102023-07-28C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-102023-07-28C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-042020-02-16C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-042020-02-16C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-062020-02-16C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-062020-02-16C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-082020-02-16C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-082020-02-16C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-102020-02-16C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-102020-02-16C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-042020-01-31C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-042020-01-31C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-062020-01-31C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-062020-01-31C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-082020-01-31C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-082020-01-31C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-102020-01-31C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-102020-01-31C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58593-275-04Rompe PechoDM118 mL in 1 BOTTLELIQUID11817
58593-275-06Rompe PechoDM178 mL in 1 BOTTLELIQUID17817
58593-275-08Rompe PechoDM237 mL in 1 BOTTLELIQUID23717
58593-275-10Rompe PechoDM10 mL in 1 POUCHLIQUID1017

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH5
GUAIFENESINACTIVE INGREDIENT495W7451VQ5
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS5
GUAIFENESINACTIVE MOIETY495W7451VQ5
ASCLEPIAS TUBEROSA ROOTINACTIVE INGREDIENT1ZL82U5D185
CAULOPHYLLUM THALICTROIDES ROOTINACTIVE INGREDIENTJTJ6HH6YEH5
ECHINACEA, UNSPECIFIEDINACTIVE INGREDIENT4N9P6CC1DX5
EUCALYPTUS GLOBULUS LEAFINACTIVE INGREDIENTS546YLW6E65
GINKGOINACTIVE INGREDIENT19FUJ2C58T5
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758H5
GOLDENSEALINACTIVE INGREDIENTZW3Z11D0JV5
HONEYINACTIVE INGREDIENTY9H1V576FH5
MENTHOLINACTIVE INGREDIENTL7T10EIP3A5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T5
MYRRHINACTIVE INGREDIENTJC71GJ1F3L5
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ45
PROPOLIS WAXINACTIVE INGREDIENT6Y8XYV2NOF5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V35
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH5
PRUNUS SEROTINA BARKINACTIVE INGREDIENT5D48E975HA5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X5
SPEARMINTINACTIVE INGREDIENTJ7I2T6IV1N5
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD45
ULMUS RUBRA BARKINACTIVE INGREDIENT91QY4PXU8Q5
VERBASCUM DENSIFLORUM LEAFINACTIVE INGREDIENT9936O846LI5
WATERINACTIVE INGREDIENT059QF0KO0R5
ZINC SULFATEINACTIVE INGREDIENT89DS0H96TB5

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58593-27558593-275-06, 58593-275-10, 58593-275-04, 58593-275-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
162024-10-10full-release2026-06-01 00:24:17

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 6 · 335 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, FILM COATED / ORAL100 mgExact identifier — unii+route
100 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, DELAYED RELEASE / ORAL97 mgExact identifier — unii+route
100 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii+route
90 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET / ORAL45 mgExact identifier — unii+route
90 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii+route
90 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, FILM COATED, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii+route
60 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii+route
90 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION / ORAL1000 mg/15mlExact identifier — unii+route
60 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4POWDER, FOR SUSPENSION / ORAL19 mgExact identifier — unii+route
60 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii+route
90 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii+route
100 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii+route
60 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ORAL98 mgExact identifier — unii+route
100 equally ranked IID candidates
ZINC SULFATEZINC SULFATE89DS0H96TBDOUCHE / VAGINAL5 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / NASAL7.4 mg/1mlExact identifier — unii+dosage form
100 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM / ORAL1 mgExact identifier — unii+route
90 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, COATED / ORAL54.7 mgExact identifier — unii+route
100 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / NASAL7.4 mg/1mlExact identifier — unii+dosage form
100 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACAPSULE / ORAL0.87 mgExact identifier — unii+route
45 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii+route
90 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAMUSCULAR17 mgExact identifier — unii+dosage form
100 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii+route
90 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii+route
60 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGRANULE, FOR SUSPENSION / ORAL162 mgExact identifier — unii+route
100 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAVENOUS6320 mgExact identifier — unii+dosage form
100 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii+route
45 equally ranked IID candidates
SPEARMINTSPEARMINTJ7I2T6IV1NSOLUTION / ORAL0.04 ml/5mlExact identifier — unii+route
20 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii+route
90 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii+route
90 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / SUBCUTANEOUS0.7 %w/vExact identifier — unii+dosage form
100 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii+route
90 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION / ORAL1000 mg/15mlExact identifier — unii+route
60 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route
90 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAVENOUS6320 mgExact identifier — unii+dosage form
100 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii+route
90 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4GRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii+route
60 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / SUBCUTANEOUS0.7 %w/vExact identifier — unii+dosage form
100 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SYRUP / ORAL2 mg/1mlExact identifier — unii+route
60 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, DELAYED RELEASE / ORAL97 mgExact identifier — unii+route
100 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, COATED / ORAL54.7 mgExact identifier — unii+route
100 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii+route
60 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, CHEWABLE / ORAL20 mgExact identifier — unii+route
100 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLIQUID / ORAL162 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route
90 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XELIXIR / ORAL1 mgExact identifier — unii+route
100 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii+route
90 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route
90 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, DELAYED RELEASE / ORAL97 mgExact identifier — unii+route
100 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION / ORAL1000 mg/15mlExact identifier — unii+route
60 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route
90 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / ORALNAExact identifier — unii+route
100 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
90 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOLUTION / ORAL3 mgExact identifier — unii+route
45 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XELIXIR / ORAL1 mgExact identifier — unii+route
100 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE / ORAL6 mgExact identifier — unii+route
100 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii+route
90 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
Rompe Pecho DMDEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Incd108c712-bc36-41d7-9ccd-720496b5599e2025-10-14WarningsExact identifier
ndc (package): 58593-275-06
ndc (package): 58593-275-10
ndc (package): 58593-275-04
ndc (package): 58593-275-08
ndc (product): 58593-275
ndc11 (package): 58593027510
ndc11 (package): 58593027508
ndc11 (package): 58593027506
ndc11 (package): 58593027504
spl id: 411e98a6-621c-3e32-e063-6394a90aa647
spl set id: d108c712-bc36-41d7-9ccd-720496b5599e

Reported adverse events (FAERS/openFDA)#

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