Drugplain

Rompe Pecho CF 10 mg/5mL

Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL · LIQUID · Efficient Laboratories Inc

2 Recalls on Record
Plain English

Rompe Pecho CF is a liquid containing dextromethorphan hbr, guaifenesin, phenylephrine hcl at 10 mg/5mL, taken oral. Manufactured by Efficient Laboratories Inc.

Key Facts

Brand Name
Rompe Pecho CF
Generic Name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL
NDC Code (Product)
58593-235
Manufacturer
Efficient Laboratories Inc
Strength
10 mg/5mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
10/01/2007

Recall History

2 Recalls on Record
Class II01/31/2020

Efficient Laboratories, Inc.

Microbial Contamination of Non-Sterile Products

TerminatedVoluntary: Firm initiated
Class II08/24/2021

Efficient Laboratories, Inc.

Microbial Contamination of Non-Sterile Products

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

cough2 reports
abdominal discomfort1 reports
diarrhoea1 reports
fatigue1 reports
headache1 reports
insomnia1 reports
migraine1 reports
nausea1 reports
pain1 reports
product use issue1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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

Warnings

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.

Frequently Asked Questions

What is Rompe Pecho CF used for?

Rompe Pecho CF contains Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL. It is a liquid taken oral. Consult your doctor for specific uses.

Is Rompe Pecho CF a controlled substance?

Rompe Pecho CF is not classified as a controlled substance by the DEA.

What is the generic name for Rompe Pecho CF?

The generic name for Rompe Pecho CF is Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL. There are 12 other brand versions of Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL.

What is the NDC code for Rompe Pecho CF 10 mg/5mL?

The NDC (National Drug Code) for Rompe Pecho CF 10 mg/5mL is 58593-235, listed by Efficient Laboratories Inc.