Rompe Pecho CF

Manufacturer
Efficient Laboratories Inc
Effective date
2024-10-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:23:10

Label at a glance#

ProductRompe Pecho CF CF
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

Brompheniramine Maleate 4mg ................................................ Antihistamine

Dextromethorphan HBr 10 mg .................................................... Cough Suppressant

OTC - PURPOSE SECTION

Purpose

Antihistamine

Cough Suppressant

WARNINGS SECTION

Warnings

Do not exceed recommended dosage.

Do not use

  • If you are 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 your doctor or pharmacist before taking this product.

OTC - DO NOT USE SECTION



Ask a doctor before use if you have

• heart disease

  • glaucoma

• high blood pressure

• thyroid disease

• diabetes

• difficulty in urination due to an enlarged prostate gland

• a persistent or chronic cough such as occurs with smoking, asthma, or emphysema

  • a cough that is accompanied by excessive phlegm (mucus)

• a breathing problem such as emphysema or chronic bronchitis



Stop use and ask doctor if

  • symptoms do not improve within 7 days, cough tends to recur, or symptoms are accompanied by a fever, rash or persistent headache. A persistent cough may be sign of a serious condition.
  • nervousness, dizziness, or sleeplessness occurs

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

  • Do not exceed more than 6 doses in any 24-hour period
  • Shake well before use
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL=miliiter TSP=teaspoonful
  • this adult product is not intended for use in children under 12 years of age
Age
  • Dose
  • adults and children 12 years of age and over
  • 5 mL (1 teaspoonfuls) every 4 hours
  • children under 6 years of age
  • do not use

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves runny nose, sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever or other upper respiratory allergies
  • temporarily relieves cough from the common cold

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

www.efficientlabs.com

Distributed by

Efficient Laboratories, Inc., Miami, Fl 33166

Made in U.S.A.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabelPackPack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2676758brompheniramine maleate 4 MG / dextromethorphan hydrobromide 10 MG in 5 mL Oral SolutionPSN5
2676758brompheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 2 MG/ML Oral SolutionSCD5
2676758brompheniramine maleate 4 MG / dextromethorphan hydrobromide 10 MG per 5 ML Oral SolutionSY5

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
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c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58593-001-06Rompe Pecho CFCF178 mL in 1 BOTTLELIQUID1785

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58593-001ROMPE PECHO CF CF (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) LIQUID [EFFICIENT LABORATORIES INC]5Current NDC, 1 package rows20241010_06e96e0c-f21f-e706-e063-6294a90a0780.zip

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
58593-00158593-001-06

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

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 CF CFBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBREfficient Laboratories Inc06e96e0c-f21f-e706-e063-6294a90a07802024-10-08WarningsExact identifier
ndc (package): 58593-001-06
ndc (product): 58593-001
ndc11 (package): 58593000106
spl id: 23f92979-e90b-8620-e063-6294a90a9790
spl set id: 06e96e0c-f21f-e706-e063-6294a90a0780

Reported adverse events (FAERS/openFDA)#

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