Rompe Pecho

Manufacturer
Efficient Laboratories, Inc.
Effective date
2025-10-14
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-06-01 01:38:53

Label at a glance#

ProductRompe Pecho SF
Active ingredientGUAIFENESIN
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


Active Ingredient (In each 5ml teaspoonful)................. Purpose


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

OTC - PURPOSE SECTION


Purpose

Expectorant

INDICATIONS & USAGE SECTION


Uses

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

OTC - DO NOT USE SECTION

Stop use and ask a doctor if
•
cough persists for more than 1 week, tends to recur, or is accompainied by a fever, rash or persistent headache. A persistent cough may be a sign of serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Keep out of reach of children.
In case of accidental overdose, get medical help or contact the Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION


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

DOSAGE & ADMINISTRATION SECTION

Directions:Shake well before use. Do not exceed 6 doses in any 24 hour period or as directed by a doctor

 AgeDose
adults and children 12 years of age and over 10 mL (2tsps) every 4 hours
children 6 to under 12 years of age 5 mL (1 tsp) every 4 hours 
children under 6 years of age consult a doctor 

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Blue Cohosh root extract, Citric Acid, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, Glycerin, Golden Seal Root extract, Honey Flavor, Horehound, Licorice Root extract, Menthol, Methylparaben, Mullein Leaf extract, Myrrh gum extract, Potassium Citrate, Potassium Sorbate, Propylene Glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Sucralose, Water, Wild Cherry Bark extract and Zinc Sulfate.

OTC - QUESTIONS SECTION

Questions or Comments?


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

www.efficientlabs.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

boxbox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN15
1112205Rompe Pecho 100 MG in 5 mL Oral SolutionPSN15
1112205guaifenesin 20 MG/ML Oral Solution [Rompe Pecho]SBD15
310604guaifenesin 20 MG/ML Oral SolutionSCD15
310604guaifenesin 100 MG per 5 ML Oral SolutionSY15
310604guaifenesin 100 MG per 5 ML Oral SyrupSY15
310604guaifenesin 200 MG per 10 ML Oral SolutionSY15
310604guaifenesin 300 MG per 15 ML Oral SolutionSY15
310604guaifenesin 400 MG per 20 ML Oral SolutionSY15
1112205Rompe Pecho 100 MG per 5 ML Oral SolutionSY15
1112205Rompe Pecho 20 MG/ML Oral SolutionSY15

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
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 SF (done).jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58593-265-04Rompe PechoSF118 mL in 1 BOTTLELIQUID11815
58593-265-06Rompe PechoSF178 mL in 1 BOTTLELIQUID17815

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQ4
GUAIFENESINACTIVE MOIETY495W7451VQ4
CAULOPHYLLUM THALICTROIDES ROOTINACTIVE INGREDIENTJTJ6HH6YEH4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP4
ECHINACEA, UNSPECIFIEDINACTIVE INGREDIENT4N9P6CC1DX4
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6624
GINKGOINACTIVE INGREDIENT19FUJ2C58T4
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758H4
GOLDENSEALINACTIVE INGREDIENTZW3Z11D0JV4
HOREHOUNDINACTIVE INGREDIENTK08036XEJV4
MENTHOLINACTIVE INGREDIENTL7T10EIP3A4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T4
MYRRHINACTIVE INGREDIENTJC71GJ1F3L4
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FF4
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ44
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH4
PRUNUS SEROTINA BARKINACTIVE INGREDIENT5D48E975HA4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X4
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD44
ULMUS RUBRA BARKINACTIVE INGREDIENT91QY4PXU8Q4
VERBASCUM DENSIFLORUM LEAFINACTIVE INGREDIENT9936O846LI4
WATERINACTIVE INGREDIENT059QF0KO0R4
ZINC SULFATEINACTIVE INGREDIENT89DS0H96TB4

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58593-26558593-265-04, 58593-265-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
142024-10-14full-release2026-06-01 00:25:15

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 4 · 207 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ORAL98 mgExact identifier — unii+route
60 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGRANULE, FOR SUSPENSION / ORAL162 mgExact identifier — unii+route
60 equally ranked IID candidates
POTASSIUM CITRATEPOTASSIUM CITRATEEE90ONI6FFPOWDER, FOR SOLUTION / ORAL570 mgExact identifier — unii+route
9 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, COATED / ORAL54.7 mgExact identifier — unii+route
60 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACAPSULE / ORAL0.87 mgExact identifier — unii+route
27 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ATABLET, ORALLY DISINTEGRATING / ORAL14 mgExact identifier — unii+route
27 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOLUTION, CONCENTRATE / ORAL0.5 mg/1mlExact identifier — unii+route
27 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii+route
54 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / ORAL148 mgExact identifier — unii+route
60 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, FILM COATED / ORAL100 mgExact identifier — unii+route
60 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SYRUP / ORAL2 mg/1mlExact identifier — unii+route
36 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, CHEWABLE / ORAL20 mgExact identifier — unii+route
60 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CAPSULE / ORALNAExact identifier — unii+route
36 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, FILM COATED, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route
54 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CONCENTRATE / ORAL1 mgExact identifier — unii+route
36 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION / ORAL1000 mg/15mlExact identifier — unii+route
36 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XELIXIR / ORAL1 mgExact identifier — unii+route
60 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / NASAL7.4 mg/1mlExact identifier — unii+dosage form
60 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE, EXTENDED RELEASE / ORAL41 mgExact identifier — unii+route
60 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4POWDER, FOR SUSPENSION / ORAL19 mgExact identifier — unii+route
36 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii+route
27 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4POWDER, FOR SUSPENSION / ORAL19 mgExact identifier — unii+route
36 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / NASAL7.4 mg/1mlExact identifier — unii+dosage form
60 equally ranked IID candidates
POTASSIUM CITRATEPOTASSIUM CITRATEEE90ONI6FFSOLUTION / ORAL913 mgExact identifier — unii+route
9 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ORAL98 mgExact identifier — unii+route
60 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, FILM COATED, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii+route
54 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CAPSULE / ORALNAExact identifier — unii+route
36 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET / ORAL231 mgExact identifier — unii+route
60 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, DELAYED RELEASE / ORAL97 mgExact identifier — unii+route
60 equally ranked IID candidates
POTASSIUM CITRATEPOTASSIUM CITRATEEE90ONI6FFSUSPENSION / ORALNAExact identifier — unii+route
9 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii+route
54 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii+route
54 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ATABLET / ORAL0.58 mgExact identifier — unii+route
27 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii+route
60 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XELIXIR / ORAL1 mgExact identifier — unii+route
60 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOLUTION / ORAL3 mgExact identifier — unii+route
27 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii+route
60 equally ranked IID candidates
ZINC SULFATEZINC SULFATE89DS0H96TBDOUCHE / VAGINAL5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route
54 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGRANULE, FOR SUSPENSION / ORAL162 mgExact identifier — unii+route
60 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii+route
54 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3APOWDER, FOR SOLUTION / ORALNAExact identifier — unii+route
27 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii+route
54 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ORAL98 mgExact identifier — unii+route
60 equally ranked IID candidates
POTASSIUM CITRATEPOTASSIUM CITRATEEE90ONI6FFPOWDER, FOR SOLUTION / ORAL570 mgExact identifier — unii+route
9 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii+route
54 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / ORALNAExact identifier — unii+route
60 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4GRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii+route
36 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACONCENTRATE / ORAL0.05 mg/5mlExact identifier — unii+route
27 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii+route
54 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET / ORAL6 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii+route
54 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
54 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route
54 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, DELAYED RELEASE / ORAL97 mgExact identifier — unii+route
60 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE / ORAL6 mgExact identifier — unii+route
60 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE, EXTENDED RELEASE / ORAL41 mgExact identifier — unii+route
60 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 SFGUAIFENESINEfficient Laboratories, Inc.31ff48fc-9603-413c-ab7c-2598b3e08f9c2025-10-14WarningsExact identifier
ndc (package): 58593-265-04
ndc (package): 58593-265-06
ndc (product): 58593-265
ndc11 (package): 58593026506
ndc11 (package): 58593026504
spl id: 411e96f1-d9a3-1820-e063-6294a90a8a69
spl set id: 31ff48fc-9603-413c-ab7c-2598b3e08f9c

Reported adverse events (FAERS/openFDA)#

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