Rompe Pecho

Manufacturer: Efficient Laboratories Inc
Effective date: 2024-11-14
Label type: HUMAN OTC DRUG LABEL
Version: 12
Source: full-release
Hydrated at: 2026-06-01 00:37:29

Label at a glance#

ProductRompe Pecho EX

Active ingredientGUAIFENESIN

Label structure12 sections

Contacts and useful links#

PhoneLabel contact305-805-3456

Websitewww.efficientlabs.com

www.efficientlabs.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

Guaifenesin 200 mg ................................................................... Expectorant

OTC - PURPOSE SECTION

Purpose

Expectorant

INDICATIONS & USAGE SECTION

Uses:

Helps loosen phlegm (mucus) and thin bronchial secretions to rid 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 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 overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

do not exceed more than 6 doses in any 24 hour period
mL=milliliter
this adult product is not intended for use in children under 12 years

Age	Dose
adults and children 12 years and over	10 mL (2 teaspoonful) every 4 hours
children under 12 years of age	do not use

OTHER SAFETY INFORMATION

Other information

each 10 mL contains: potassium 5 mg
store between 15° - 30°C (59° - 86°F). Do not refrigerate
product color & flavor may vary due to natural honey

TAMPER - EVIDENT FEATURE: Do not use this product if printed safety seal over cap is torn, broken or missing.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Blue Cohosh root extract, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, glycerin, Golden Seal Root extract,
Honey, Horehound (flower, leaf, stem) extract, Licorice Root extract, Menthol, Methylparaben, Mullein leaf extract, Myrrh gum extract, 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 to 5PM EST) or www.efficientlabs.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelbox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	12
1112205	Rompe Pecho 100 MG in 5 mL Oral Solution	PSN	12
1112205	guaifenesin 20 MG/ML Oral Solution [Rompe Pecho]	SBD	12
310604	guaifenesin 20 MG/ML Oral Solution	SCD	12
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	12
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	12
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	12
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	12
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	12
1112205	Rompe Pecho 100 MG per 5 ML Oral Solution	SY	12
1112205	Rompe Pecho 20 MG/ML Oral Solution	SY	12

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58593-829-04	2023-08-03	C162847	48780-1	0191ceaa-6550-198a-e063-dbdaa90aec3e	Drug Facts
58593-829-06	2023-08-03	C162847	48780-1	0191ceaa-6550-198a-e063-dbdaa90aec3e	Drug Facts
58593-829-04	2023-07-28	C162847	48780-1	0191ceaa-6550-198a-e063-dbdaa90aec3e	Drug Facts
58593-829-06	2023-07-28	C162847	48780-1	0191ceaa-6550-198a-e063-dbdaa90aec3e	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58593-829-04	Rompe PechoEX	118 mL in 1 BOTTLE	LIQUID	118		12
58593-829-06	Rompe PechoEX	178 mL in 1 BOTTLE	LIQUID	178		12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58593-829	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	12	Current NDC, Legacy NDC, 2 package rows	20241116_89ea23a5-0da7-407e-83d9-77a0b562f3af.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	1
ASCLEPIAS TUBEROSA ROOT	INACTIVE INGREDIENT	1ZL82U5D18	1
CAULOPHYLLUM THALICTROIDES ROOT	INACTIVE INGREDIENT	JTJ6HH6YEH	1
ECHINACEA, UNSPECIFIED	INACTIVE INGREDIENT	4N9P6CC1DX	1
EUCALYPTUS GLOBULUS LEAF	INACTIVE INGREDIENT	S546YLW6E6	1
GINKGO	INACTIVE INGREDIENT	19FUJ2C58T	1
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	1
GOLDENSEAL	INACTIVE INGREDIENT	ZW3Z11D0JV	1
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	1
HOREHOUND	INACTIVE INGREDIENT	K08036XEJV	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
MYRRH	INACTIVE INGREDIENT	JC71GJ1F3L	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
PRUNUS SEROTINA BARK	INACTIVE INGREDIENT	5D48E975HA	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	1
ULMUS RUBRA BARK	INACTIVE INGREDIENT	91QY4PXU8Q	1
VERBASCUM DENSIFLORUM LEAF	INACTIVE INGREDIENT	9936O846LI	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
ZINC SULFATE	INACTIVE INGREDIENT	89DS0H96TB	1

Products#

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

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

Rompe Pecho EX
Guaifenesin
GLYCERIN
SUCRALOSE
CAULOPHYLLUM THALICTROIDES ROOT
ECHINACEA, UNSPECIFIED
EUCALYPTUS GLOBULUS LEAF
GINKGO
GOLDENSEAL
HONEY
GLYCYRRHIZA GLABRA
MENTHOL
METHYLPARABEN
VERBASCUM DENSIFLORUM LEAF
MYRRH
ASCLEPIAS TUBEROSA ROOT
POTASSIUM SORBATE
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
ULMUS RUBRA BARK
SODIUM CHLORIDE
PRUNUS SEROTINA BARK
ZINC SULFATE
HOREHOUND

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58593-829	58593-829-06, 58593-829-04

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
CAULOPHYLLUM THALICTROIDES ROOT	JTJ6HH6YEH	IACT
ECHINACEA, UNSPECIFIED	4N9P6CC1DX	IACT
EUCALYPTUS GLOBULUS LEAF	S546YLW6E6	IACT
GINKGO	19FUJ2C58T	IACT
GOLDENSEAL	ZW3Z11D0JV	IACT
HONEY	Y9H1V576FH	IACT
GLYCYRRHIZA GLABRA	2788Z9758H	IACT
MENTHOL	L7T10EIP3A	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
VERBASCUM DENSIFLORUM LEAF	9936O846LI	IACT
MYRRH	JC71GJ1F3L	IACT
ASCLEPIAS TUBEROSA ROOT	1ZL82U5D18	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
ULMUS RUBRA BARK	91QY4PXU8Q	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
PRUNUS SEROTINA BARK	5D48E975HA	IACT
ZINC SULFATE	89DS0H96TB	IACT
HOREHOUND	K08036XEJV	IACT
GUAIFENESIN	495W7451VQ	ACTIB

Source Document#

Source XML

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 · 189 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CAPSULE / ORAL		6 mg	Exact identifier — unii+route 60 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 54 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET / ORAL		6 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / ORAL		148 mg	Exact identifier — unii+route 60 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	PASTE / ORAL		48 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / ORAL	1000 mg/15ml		Exact identifier — unii+route 36 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	LOZENGE / ORAL		115 mg	Exact identifier — unii+route 54 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SYRUP / ORAL		40 mg	Exact identifier — unii+route 60 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii+route 60 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CONCENTRATE / ORAL	0.05 mg/5ml		Exact identifier — unii+route 27 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii+route 54 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, EFFERVESCENT / ORAL		1080 mg	Exact identifier — unii+route 54 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii+route 54 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	POWDER, FOR SUSPENSION / ORAL		19 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / SUBCUTANEOUS	0.7 %w/v		Exact identifier — unii+dosage form 60 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, COATED / ORAL	NA		Exact identifier — unii+route 36 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	POWDER, FOR SUSPENSION / ORAL		19 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	POWDER, FOR SUSPENSION / ORAL		19 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET / ORAL		45 mg	Exact identifier — unii+route 54 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, ORALLY DISINTEGRATING / ORAL		60 mg	Exact identifier — unii+route 54 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TROCHE / ORAL		60 mg	Exact identifier — unii+route 54 equally ranked IID candidates
ZINC SULFATE	ZINC SULFATE	89DS0H96TB	DOUCHE / VAGINAL	5 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET, ORALLY DISINTEGRATING / ORAL	14 mg		Exact identifier — unii+route 27 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii+route 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, COATED / ORAL	54.7 mg		Exact identifier — unii+route 60 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, COATED / ORAL	NA		Exact identifier — unii+route 36 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	GRANULE, FOR SUSPENSION / ORAL		23 mg	Exact identifier — unii+route 54 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAMUSCULAR		17 mg	Exact identifier — unii+dosage form 60 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	GRANULE, FOR SUSPENSION / ORAL		23 mg	Exact identifier — unii+route 54 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET / ORAL		231 mg	Exact identifier — unii+route 60 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / SUBCUTANEOUS	0.7 %w/v		Exact identifier — unii+dosage form 60 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION, CONCENTRATE / ORAL	0.5 mg/1ml		Exact identifier — unii+route 27 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii+route 54 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, CHEWABLE / ORAL		20 mg	Exact identifier — unii+route 60 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SUSPENSION / ORAL		1 mg	Exact identifier — unii+route 27 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GRANULE, FOR SUSPENSION / ORAL		162 mg	Exact identifier — unii+route 60 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	GRANULE / ORAL	5.4 mg		Exact identifier — unii+route 54 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	FILM, SOLUBLE / ORAL		33 mg	Exact identifier — unii+route 54 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SYRUP / ORAL		80 mg	Exact identifier — unii+route 54 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / ORAL	1000 mg/15ml		Exact identifier — unii+route 36 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii+route 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	ELIXIR / ORAL	1 mg		Exact identifier — unii+route 60 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAMUSCULAR		17 mg	Exact identifier — unii+dosage form 60 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET / ORAL		231 mg	Exact identifier — unii+route 60 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SUSPENSION / ORAL		1 mg	Exact identifier — unii+route 27 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, CHEWABLE / ORAL		20 mg	Exact identifier — unii+route 60 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SUSPENSION / ORAL		1 mg	Exact identifier — unii+route 27 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii+route 54 equally ranked IID candidates
ZINC SULFATE	ZINC SULFATE	89DS0H96TB	DOUCHE / VAGINAL	5 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, FOR SUSPENSION / ORAL		65 mg	Exact identifier — unii+route 54 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, DELAYED RELEASE / ORAL		97 mg	Exact identifier — unii+route 60 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CONCENTRATE / ORAL	0.05 mg/5ml		Exact identifier — unii+route 27 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii+route 54 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, CHEWABLE / ORAL		20 mg	Exact 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rompe Pecho EX	GUAIFENESIN	Efficient Laboratories Inc	89ea23a5-0da7-407e-83d9-77a0b562f3af	2024-11-14	Warnings	Exact identifier ndc (package): 58593-829-04 ndc (package): 58593-829-06 ndc (product): 58593-829 ndc11 (package): 58593082906 ndc11 (package): 58593082904 spl id: 26e4f72a-b911-8dc6-e063-6394a90a4326 spl set id: 89ea23a5-0da7-407e-83d9-77a0b562f3af

Reported adverse events (FAERS/openFDA)#

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