FDA.reportPublic FDA data

Rompe Pecho CF

Manufacturer
Dextrum Laboratories, Inc
Effective date
2025-10-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:15:26

Label at a glance#

ProductRompe Pecho CF
Active ingredientBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure12 sections

Label contents#

Full prescribing information#

Active ingredient section

OTC - ACTIVE INGREDIENT SECTION

active ingredientactive ingredient

Active ingredient section

Brompheniramine melate 4mg.... Antihistamine

Dextromethorphan HBr 10 mg... Cough suppressant

Warnings

WARNINGS SECTION

Warnings

Do no exceed recommended dosage

Do not use if you are now taking a prescription monoamine oxidase inhibitor(MAOI) (certain drugs for depression, psychiatric or emotional condition, or Parkinson's disease), or 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.

WarningWarning

Ask a doctor section

OTC - ASK DOCTOR SECTION

Ask a doctorAsk a doctor

Ask a doctor section

Ask a doctor before use:

If you have heart disease, glaucoma, high pressure, thyroid disease, diabetes, dificulty in urination due to enlargement of the prostate gland, a persistent or chronic cough such as occurs with smoking, asthma or emphysema, a cough tha is accompanied by excessive phlegm (mucus), a breathing problem such as emphysema or chronic bronchitis.

Ask a doctor and pharmacist section

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor/pharmacist section

Ask a doctor or pharmacistbefore use if you are taking tranquilizers or sedatives

Ask a doctorAsk a doctor

Keep out of reach of children section.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children section.

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

Keep outKeep out

Pregnancy or breast feeding section

OTC - PREGNANCY OR BREAST FEEDING SECTION

Pregnancy or breast feeding section

If pregnancy or breaft-feeding, ask a heath professional before use

pregnantpregnant

Indication and usage section

INDICATIONS & USAGE SECTION

Indication and usage section

Do not exceed more than 6 dosesin a 24-hour period

Shake before use

measure only with dosing cup provided

keep dosing cup with product

ml=milliliters TSP=teaspoonful

This adult product is no intented for use in children under 12 years of age

Adult and children 12 years of age and over 5ml (1 teaspoonful) every 4 hours

children under 12 years of age Do not use

indication an userindication an user

Ivactives ingredient section

INACTIVE INGREDIENT SECTION

Ivactives ingredient section

Blue cohosh root extract, echinacea root extract, eucalyptus oil, ginkgo biloba leaf extract, glycerin, goldenseal root extract, honey, horehound(flower, leaft, stem) extract, licorice root extract, menthol, methylparaben, mullein leaf extract, myrrh gum extract, potassium sorbate, propylene glycol, propylparaben, slippery eilm bark extract, sodium chloride, sucralose, water, wild cherry bark extract and zinc sulfate.

inactiveinactive

Question section

OTC - QUESTIONS SECTION

Question section

Question or comments:

305-805-3456

Monday-Friday (9am - 5pm) or www.efficientlabs.com

questionquestion

Purpose section

OTC - PURPOSE SECTION

Purpose section

Antihistaminic

Cough suppressant

purposepurpose

Dosage & Administration section

Dosage & Administration section

Do not exceed more than 6 dosesin a 24-hour period

Shake before use

measure only with dosing cup provided

keep dosing cup with product

ml=milliliters TSP=teaspoonful

This adult product is no intented for use in children under 12 years of age

Adult and children 12 years of age and over 5ml (1 teaspoonful) every 4 hours

children under 12 years of age Do not use

dosagedosage

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

principal panelprincipal panel

Efficient

Rompe Pecho CF

Cold & Flu

Antihistamine

Cough Suppressant

Brompheniramine Melate

Dextromethorphan HBr

Advanced Formula

Alcohol Free

Adults and Children 12 years and over

Content: 6 FL Oz (178 ml)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2676758brompheniramine maleate 4 MG / dextromethorphan hydrobromide 10 MG in 5 mL Oral SolutionPSN1
2676758brompheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 2 MG/ML Oral SolutionSCD1
2676758brompheniramine maleate 4 MG / dextromethorphan hydrobromide 10 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65852-013-06Rompe Pecho CF178 mL in 1 BOTTLE, PLASTICLIQUID1781
65852-013-06Rompe Pecho CF1 in 1 CARTONLIQUID11

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65852-01365852-013-06

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
NameUNIIKind
HOREHOUNDK08036XEJVIACT
GINKGO BILOBA LEAF19FUJ2C58TIACT
BROMPHENIRAMINE MALEATEIXA7C9ZN03ACTIB
EUCALYPTUS OIL2R04ONI662IACT
CAULOPHYLLUM THALICTROIDES ROOTJTJ6HH6YEHIACT
LICORICE61ZBX54883IACT
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT
PRUNUS SEROTINA (WILD CHERRY) BARK5D48E975HAIACT
ZINC SULFATE89DS0H96TBIACT
HONEYY9H1V576FHIACT
ULMUS RUBRA BARK91QY4PXU8QIACT
MENTHOLL7T10EIP3AIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ECHINACEA ANGUSTIFOLIA ROOTD982V7VT3PIACT
GOLDENSEALZW3Z11D0JVIACT
METHYLPARABENA2I8C7HI9TIACT
MULLEIN LEAF9936O846LIIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
MYRRHJC71GJ1F3LIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

Source Document#

Source XML

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 CFBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRDextrum Laboratories, Inc401a97af-36ae-4e54-e063-6294a90ab3ee2025-10-01WarningsExact identifier
ndc (package): 65852-013-06
ndc (product): 65852-013
ndc11 (package): 65852001306
spl id: 401a97af-36af-4e54-e063-6294a90ab3ee
spl set id: 401a97af-36ae-4e54-e063-6294a90ab3ee

Reported adverse events (FAERS/openFDA)#

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