Rompe Pecho Max

ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN ORAL HUMAN OTC DRUG

Rompe Pecho Max is an FDA drug label for the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN manufactured by Efficient Laboratories Inc administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260415.

Generic name
ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN
Manufacturer
Efficient Laboratories Inc
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
58593-005
Application
M012
Label effective
20260415

About this product

Rompe Pecho Max is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN. It is labelled by Efficient Laboratories Inc taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 58593-005, application M012, label effective 20260415. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN are most often described in connection with: temporarily relieves, common cold, flu symptoms, cough due, minor throat, bronchial irritation, pains headache, reduces fever. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredients: (in each 30ml doses cup) Purpose Acetaminophen 650mg ............................................................ Pain reliever/fever reducer Dextromethorphan HBr 20 mg ..................................................Cough Suppressant Guaifenesin 400 mg ................................................................. Expectorant

Indications & Usage

Uses • temporarily relieves these common cold/flu symptoms: cough due to minor throat and bronchial irritation • minor aches and pains• headache• sore throat • temporarily reduces fever. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Dosage & Administration

Directions do not take more than directed (see overdose warning) 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 20 mL every 4 hours children under 12 years of age do not use

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur f you take • more than 6 doses in 24 hours, which is the maximum daily amount for this prcx:luct • with other drugs containing acetaminophen • 3 or more alcoholic drinks daily wh le using this product. Allergy alert : Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters• rash If a skin reaction occurs,stop use and seek medical help right away. Sore throat warning: If sore throat is severe,persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting,consult a doctor promptly.

Recall and safety notices

2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0293-2022 Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166 UPC 0 00856 00309 5, NDC 58593-828-08 Efficient Laboratories, Inc. Class II Terminated 20211229
D-0847-2020 New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 00309 5 Efficient Laboratories, Inc. Class II Terminated 20200219

Frequently asked questions

What is Rompe Pecho Max used for?
Uses • temporarily relieves these common cold/flu symptoms: cough due to minor throat and bronchial irritation • minor aches and pains• headache• sore throat • temporarily reduces fever. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Who makes Rompe Pecho Max?
Efficient Laboratories Inc is the labeler of record for Rompe Pecho Max.

What form does Rompe Pecho Max come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Rompe Pecho Max prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Rompe Pecho Max been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.