Drugplain

Rompe Tos X Children 250 mg/10mL

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl · SYRUP · OPMX LLC

No Recall HistoryCurrently in Shortage
Plain English

Rompe Tos X Children is a syrup containing acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl at 250 mg/10mL, taken oral. Manufactured by OPMX LLC.

Key Facts

Brand Name
Rompe Tos X Children
Generic Name
Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
NDC Code (Product)
69729-784
Manufacturer
OPMX LLC
Strength
250 mg/10mL
Dosage Form
SYRUP
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
09/18/2023

Recall History

No Recall History

Side Effects Reported to FDA

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

toxicity to various agents2 reports
anaphylactic reaction1 reports
choking1 reports
erythema1 reports
heart rate increased1 reports
intentional product misuse1 reports
medication error1 reports
peripheral swelling1 reports
pharyngeal swelling1 reports
product contamination microbial1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these common cold/flu symptoms: sinus congestion & pressure minor aches & pains nasal congestion cough due to minor throat & bronchial irritation sore throat headache temporarily reduces fever temporarily promotes nasal and/or sinus drainage 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 take more than 6 doses in any 24 hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter tsp = teaspoonful Age Dose Children 6 to under 12 years of age 10 mL or 2 tsp provided every 4 hours Children under 6 years of age do not use

Warnings

Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 6 doses in 24 hrs, which is the maximum daily amount for this product • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while 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. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for children under 12 years of age 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

Frequently Asked Questions

What is Rompe Tos X Children used for?

Rompe Tos X Children contains Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl. It is a syrup taken oral. Consult your doctor for specific uses.

Is Rompe Tos X Children a controlled substance?

Rompe Tos X Children is not classified as a controlled substance by the DEA.

What is the generic name for Rompe Tos X Children?

The generic name for Rompe Tos X Children is Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl. There are 11 other brand versions of Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl.

What is the NDC code for Rompe Tos X Children 250 mg/10mL?

The NDC (National Drug Code) for Rompe Tos X Children 250 mg/10mL is 69729-784, listed by OPMX LLC.