Rompe Pecho SF Flu

Manufacturer
Efficient Laboratories Inc
Effective date
2024-10-07
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:23:10

Label at a glance#

ProductRompe Pecho SF Flu SF Flu
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE
Label structure13 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, citric acid, Echinacea root extract, Eucalyptus Oil, Flavor, 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 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 to 5PM EST

www.efficientlabs.com

Distributed by

Efficient Laboratories, Inc., Miami, Fl 33166

Made in U.S.A.

Ask a doctor or pharmacist before use if you are:

OTC - ASK DOCTOR SECTION

taking tranquilizers or sedatives

When using this product

OTC - WHEN USING SECTION


When using this product • may cause marked drowsiness • avoid alcoholic drinks• Alcohol, sedatives, and tranquilizers may increase drowsiness effect • use caution when driving a motor vehicle or operating machinery • excitability may occur, especially in childrens.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2676758brompheniramine maleate 4 MG / dextromethorphan hydrobromide 10 MG in 5 mL Oral SolutionPSN6
2676758brompheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 2 MG/ML Oral SolutionSCD6
2676758brompheniramine maleate 4 MG / dextromethorphan hydrobromide 10 MG per 5 ML Oral SolutionSY6

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58593-002-06Rompe Pecho SF FluSF Flu178 mL in 1 BOTTLELIQUID1786

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58593-002ROMPE PECHO SF FLU SF FLU (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) LIQUID [EFFICIENT LABORATORIES INC]6Current NDC, 1 package rows20241010_06eac696-e8f6-ac50-e063-6394a90a2ed6.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58593-00258593-002-06

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

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 SF Flu SF FluBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBREfficient Laboratories Inc06eac696-e8f6-ac50-e063-6394a90a2ed62024-10-07WarningsExact identifier
ndc (package): 58593-002-06
ndc (product): 58593-002
ndc11 (package): 58593000206
spl id: 23eb017d-6da7-5f0a-e063-6294a90a78c0
spl set id: 06eac696-e8f6-ac50-e063-6394a90a2ed6

Reported adverse events (FAERS/openFDA)#

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