Rompe Pecho Max Multi Symptoms

Description

No specific description details are available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including nasal congestion, sinus congestion and pressure, cough due to minor throat and bronchial irritation, minor aches and pains, sore throat, headache, and fever. Additionally, it promotes nasal and/or sinus drainage, temporarily alleviating sinus congestion and pressure. The formulation also aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of bothersome mucus and enhancing the productivity of coughs.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 20 mL administered every 4 hours, with a maximum of 6 doses within a 24-hour period. It is imperative to shake the product well before each use. The dosing should be measured exclusively with the dosing cup provided, which should be kept with the product at all times. This formulation is not intended for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

• In cases where the patient is uncertain if a drug contains acetaminophen; consultation with a healthcare professional is advised.

• In patients with persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, or when cough is accompanied by excessive phlegm, unless directed by a physician.

• In individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases if they 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 taken in conjunction with other medications containing acetaminophen or when patients consume three or more alcoholic drinks daily while using this product.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

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

Patients should be advised to stop use and consult a doctor if symptoms do not improve within seven days, recur, or are accompanied by fever, rash, or persistent headache. A persistent cough may indicate a serious condition. Additional caution is warranted if patients experience nervousness, dizziness, or sleeplessness. If pain and nasal congestion worsen or last longer than five days in children or seven days in adults, or if fever worsens or lasts more than three days, medical advice should be sought. Redness, swelling, or the emergence of new symptoms also necessitates consultation with a healthcare professional.

Emergency medical help should be sought in accordance with standard medical protocols if severe adverse reactions occur.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can be categorized by seriousness and frequency.

Severe adverse reactions include the risk of liver damage associated with acetaminophen. This risk is heightened if patients exceed 6 doses within a 24-hour period, take other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. In the event of an overdose, which may occur if the recommended dose is exceeded, patients should seek immediate medical assistance or contact a Poison Control Center, as prompt medical attention is crucial even if no symptoms are initially apparent.

Patients may also experience severe skin reactions, characterized by symptoms such as skin reddening, blisters, or rash. Should any of these symptoms occur, it is imperative to discontinue use and seek medical help immediately. Additionally, if 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.

Common adverse reactions may include nervousness, dizziness, or sleeplessness. Patients should discontinue use and consult a doctor if symptoms do not improve within 7 days, recur, or are accompanied by fever, rash, or persistent headache. Furthermore, worsening pain and nasal congestion lasting more than 5 days in children or 7 days in adults, as well as a fever lasting more than 3 days, warrant medical consultation. The presence of redness, swelling, or the emergence of new symptoms should also prompt patients to seek medical advice.

Patients with pre-existing conditions such as heart disease, liver disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland should consult a doctor before using this product. Additionally, those with a persistent or chronic cough, particularly if associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice prior to use. It is also recommended that patients taking blood thinners like warfarin or tranquilizers/sedatives consult a healthcare professional before using this product.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is not recommended in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric disorders, or Parkinson's disease, and their interaction with this medication may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication. The combination may increase the risk of bleeding, necessitating careful monitoring of coagulation parameters.

Additionally, individuals using tranquilizers or sedatives are advised to seek guidance from a healthcare provider before initiating this medication. The potential for additive central nervous system depression may warrant dosage adjustments or increased monitoring for sedation-related side effects.

Packaging & NDC

Below are the non-prescription pack sizes of Rompe Pecho Max Multi Symptoms (acetaminophen, dextromethophan hbr, phenylephrine hcl, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This adult strength product is not intended for use in pediatric patients under 12 years of age. For those 12 years and older, the recommended dosage is 20 mL every 4 hours. There are no established safety or efficacy profiles for children under 12, and therefore, use in this population is contraindicated.

Geriatric Use

Elderly patients, defined as those aged 65 and older, do not require specific dosage adjustments or safety considerations based on the available prescribing information. The insert does not outline any special precautions or recommendations tailored specifically for this demographic.

However, it is advisable for healthcare providers to consult with a physician prior to use in elderly patients who have underlying health conditions such as heart disease, liver disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to an enlarged prostate gland. These conditions may be particularly relevant in the geriatric population and warrant careful evaluation before initiating treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

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

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur under certain conditions. Specifically, patients should not exceed 6 doses within a 24-hour period, as this is the maximum daily amount for this product.

Additionally, patients must be cautioned against the concurrent use of other medications containing acetaminophen, as this can significantly increase the risk of liver damage. Furthermore, consumption of 3 or more alcoholic drinks daily while using this product may also contribute to severe liver injury.

Due to these risks, it is advisable for healthcare providers to assess liver function and consider dosage adjustments or alternative therapies for patients with compromised liver function. Regular monitoring of liver enzymes may be warranted to ensure patient safety.

Overdosage

Taking more than the recommended dose of the medication may lead to serious health consequences, including potential liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center. Prompt medical intervention is crucial, even if the individual does not exhibit any immediate signs or symptoms of overdose.

Healthcare professionals should be aware that early recognition and management of overdose can significantly impact patient outcomes. It is essential to monitor the patient closely and provide supportive care as needed.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Similarly, no data has been provided concerning non-teratogenic effects. Additionally, there is no information available in the nonclinical toxicology section. Furthermore, no details have been reported in the context of animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed 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.

Patients should be cautioned against using this medication if they have a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, or if their cough is accompanied by excessive phlegm, unless directed by a healthcare professional. Additionally, patients taking prescription monoamine oxidase inhibitors (MAOIs) for depression, psychiatric conditions, or Parkinson's disease should not use this product, nor should they use it for two weeks after discontinuing an MAOI. If patients are unsure whether their prescription includes an MAOI, they should seek guidance from a doctor or pharmacist.

Patients should be instructed to stop using the medication and consult a doctor if their symptoms do not improve within seven days, if symptoms recur, or if they experience fever, rash, or persistent headache. They should also be advised to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Furthermore, patients should be informed to stop use and consult a doctor if pain and nasal congestion worsen or last longer than five days in children or seven days in adults, if fever worsens or lasts more than three days, or if they notice redness, swelling, or new symptoms.

When using this product, patients should be reminded not to exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: heart disease, liver disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients with a persistent or chronic cough or a cough accompanied by excessive phlegm should also seek medical advice prior to use. Additionally, patients taking the blood-thinning medication warfarin, tranquilizers, or sedatives should be advised to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in a container that includes a dosing cup. It is essential to store the product at a temperature range of 20°C to 25°C (68°F to 77°F) and to protect it from light. Prior to use, the product must be shaken well. After opening, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Rompe Pecho Max Multi Symptoms, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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