Rompe Pecho Nighttime 650 mg/30mL

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl · LIQUID · EFFICIENT LABORATORIES INC

No Recall HistoryCurrently in Shortage

Plain English

Rompe Pecho Nighttime is a liquid containing acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl at 650 mg/30mL, taken oral. Manufactured by EFFICIENT LABORATORIES INC.

Key Facts

Brand Name: Rompe Pecho Nighttime
Generic Name: Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
NDC Code (Product): 58593-830
Manufacturer: EFFICIENT LABORATORIES INC
Strength: 650 mg/30mL
Dosage Form: LIQUID
Route: ORAL
Marketing Status
Application #: M012
Marketing Start: 09/01/2019

Recall History

No Recall History

Side Effects Reported to FDA

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

abdominal discomfort1 reports

diarrhoea1 reports

headache1 reports

migraine1 reports

nausea1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these common cold/flu symtoms: minor aches and pains headache nasal congestion sore throat runny nose and sneezing cough sinus congestion and pressure helps clear nasal passages relieves cough to help you get to sleep temporarily reduces fever

Dosage & Administration

Directions do not take more than directed (see Overdose warning) do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. Product color & flavor may vary due to natural honey. mL = milliliter shake well before use keep dosing cup with product Adults and Children 12 years & over: 30 mL every 4 hours Children under 12 years of age: do not use

Warnings

Warnings Liver warning: This product contains acetaminophen. Sever liver damage may occur if you take more than 6 doses in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Allergy alert: Acetaminophen may cause sever skin reactions. Symptoms may include: skin reddening blisters rash If skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is sever, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminphen, ask a doctor or pharmacist. if you are now 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 you prescription drug contains a MAOI, ask a doctor or pharmalacist before taking this product. to make a child sleep Ask a doctor before use if you ha…

Frequently Asked Questions

What is Rompe Pecho Nighttime used for?

Rompe Pecho Nighttime contains Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl. It is a liquid taken oral. Consult your doctor for specific uses.

Is Rompe Pecho Nighttime a controlled substance?

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

What is the generic name for Rompe Pecho Nighttime?

The generic name for Rompe Pecho Nighttime is Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl. There are 11 other brand versions of Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl.

What is the NDC code for Rompe Pecho Nighttime 650 mg/30mL?

The NDC (National Drug Code) for Rompe Pecho Nighttime 650 mg/30mL is 58593-830, listed by EFFICIENT LABORATORIES INC.

Product NDC

58593-830

Package NDC

58593-830-06

Other Acetaminophen, Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)