Rompe Tos X Adults

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza, including sinus congestion and pressure, minor aches and pains, nasal congestion, cough due to minor throat and bronchial irritation, sore throat, headache, and fever. Additionally, it temporarily promotes nasal and/or sinus drainage and helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. The maximum dosage should not exceed the specified limits to avoid the risk of overdose.

For adults and children aged 12 years and older, the recommended dose is 20 mL, to be measured using the dosing cup provided, administered every 4 hours as needed. It is imperative that no more than 6 doses are taken within a 24-hour period.

For children under 12 years of age, the use of this product is not recommended.

Healthcare professionals should instruct patients to utilize the dosing cup exclusively for this product and to refrain from using it with any other medications to ensure accurate dosing.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In children under 12 years of age, as safety and efficacy have not been established in this population.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, due to potential interactions that may lead to serious adverse effects. If there is uncertainty regarding the presence of an MAOI in a prescription drug, a healthcare professional should be consulted.

Additionally, it is important to adhere to the recommended dosage to avoid the risk of overdose.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage guidelines. Specifically, patients should not exceed 6 doses within a 24-hour period, which is the maximum daily amount for this product. Additionally, caution is warranted when this product is used in conjunction with other medications containing acetaminophen, as this can increase the risk of liver damage. Patients should also be advised against consuming 3 or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, patients must be instructed to discontinue use immediately and seek medical assistance.

Healthcare professionals should be vigilant regarding patients presenting with a severe sore throat. If the sore throat persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

Patients should be advised to stop using the product and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts longer than 7 days, or if fever worsens or persists beyond 3 days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting longer than usual may indicate a serious condition requiring medical evaluation.

In cases of overdose, which may result from exceeding the recommended dosage, patients must seek immediate medical attention or contact a Poison Control Center. Quick medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of six doses within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases where a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should also stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than seven days; if fever worsens or lasts more than three days; if redness or swelling is present; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that persists. These symptoms may indicate a serious condition.

An overdose of this product, defined as taking more than the recommended dose, may lead to liver damage. In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Rompe Tos X Adults (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For patients aged 12 years and older, the recommended dosage is 20 mL, administered every 4 hours using the dosing cup provided. Caution is advised when considering the use of this medication in pediatric populations, as safety and efficacy have not been established in children under 12 years.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily amount of 6 doses within a 24-hour period. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if patients consume 3 or more alcoholic drinks daily while using this product.

Patients with a history of liver disease are advised to consult a healthcare professional prior to use. It is crucial for these patients to adhere strictly to the recommended dosage to avoid the risk of overdose, which may lead to liver damage. In the event of an overdose, immediate medical attention is essential. Patients should seek help or contact a Poison Control Center without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dosage is exceeded. It is imperative that healthcare professionals recognize the seriousness of this situation and act promptly.

Immediate medical assistance should be sought in cases of suspected overdose. Healthcare providers are advised to contact a Poison Control Center without delay. This is crucial for both adults and children, as timely intervention can mitigate the risk of severe complications.

Even in the absence of noticeable signs or symptoms, it is essential to seek quick medical attention, particularly for pediatric patients. Vigilance in monitoring and managing overdose cases can be pivotal in ensuring patient safety and preventing adverse outcomes.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to inform patients that this product is not recommended for use in children under 12 years of age. Additionally, patients should be cautioned against using this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be advised to seek clarification from a healthcare professional if they are unsure whether their prescription includes an MAOI.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. They should also be advised to stop using the product and seek medical advice if pain, nasal congestion, or cough worsens or persists for more than 7 days, if fever worsens or lasts more than 3 days, or if any redness or swelling occurs. Patients should be made aware that new symptoms may warrant medical consultation, and they should seek immediate advice if a cough returns or occurs alongside a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dose, and they should be informed of the potential risks associated with overdose. Patients with liver disease, heart disease, diabetes, thyroid disease, high blood pressure, or those experiencing difficulty urinating due to an enlarged prostate gland should be advised to consult a doctor before using this medication. Furthermore, patients with a persistent or chronic cough, such as those caused by smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Patients should be encouraged to consult a healthcare professional if they have a cough accompanied by excessive phlegm (mucus).

Lastly, patients taking the blood-thinning medication warfarin or those on a sodium-restricted diet should be advised to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in a carton that contains essential Drug facts. It is important to store the product at a temperature range of 20-25°C (68-77°F). Refrigeration is not recommended, as the product should not be exposed to lower temperatures. To ensure proper handling and to maintain the integrity of the product, the carton should be retained for reference to the complete Drug facts.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Rompe Tos X Adults, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)