Rompe Pecho Nt

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, headache, sore throat, runny nose, sneezing, and cough. It also provides relief from cough to facilitate sleep and temporarily reduces fever.

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

Dosage and Administration

Adults and children 12 years of age and older are advised to administer 30 mL every 4 hours as needed. It is imperative that the total number of doses does not exceed 6 doses within a 24-hour period.

Prior to administration, the product must be shaken well to ensure proper mixing. The dosing cup provided with the product should be used exclusively for measuring the dose, and it is recommended to keep the dosing cup with the product for convenience and accuracy.

This product 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.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions.

• Administration to children for the purpose of inducing sleep is contraindicated, as it may pose safety risks.

Additionally, it is advised to keep this product out of reach of children and to adhere strictly to the recommended dosage. Avoidance of alcoholic beverages is also recommended during use.

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 may 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 discontinue use immediately and seek medical assistance.

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

An overdose of acetaminophen can lead to significant liver damage. In cases of suspected overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) without delay, as rapid intervention is critical for both adults and children, even in the absence of overt signs or symptoms.

Patients should be advised to discontinue use and consult a healthcare provider if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening pain or cough lasting more than 7 days; the emergence of new symptoms; fever that worsens or persists for more than 3 days; the presence of redness or swelling; or if a cough recurs or occurs alongside a rash or headache that lasts.

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.

Additional adverse reactions warranting medical consultation include the onset of nervousness, dizziness, or sleeplessness; worsening pain or cough lasting more than seven days; the emergence of new symptoms; fever that worsens or lasts more than three days; the presence of redness or swelling; or a cough that recurs or occurs alongside a rash or headache that persists.

Drug Interactions

Concurrent use 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 also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric or emotional disorders, or Parkinson's disease. Additionally, it should not be administered for at least 2 weeks following the discontinuation of an MAOI.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding.

Caution is advised for individuals using sedatives or tranquilizers, as the combination may enhance the sedative effects, leading to increased drowsiness. It is recommended that patients seek guidance from a healthcare provider before concurrent use of these agents.

Furthermore, the consumption of alcohol in conjunction with this medication, as well as with sedatives and tranquilizers, may exacerbate drowsiness and should be approached with caution.

Packaging & NDC

Below are the non-prescription pack sizes of Rompe Pecho Nt (acetaminophen, dextromethorphan hbr, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. The safety and efficacy of this medication have not been established in children younger than 12, and its use in this population is contraindicated.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored 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, patients must avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

It is also critical for patients with compromised liver function to limit alcohol consumption. Specifically, the intake of 3 or more alcoholic drinks daily while using this product is contraindicated, as it may exacerbate the potential for severe liver damage. Regular assessment of liver function is recommended for patients with hepatic impairment to ensure safe use of this medication.

Overdosage

In cases of overdosage, significant health risks are associated with exceeding the recommended dosage of this product.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if a patient ingests more than six doses within a 24-hour period, which is the maximum daily allowance for this product. Additionally, the concomitant use of this product with other medications containing acetaminophen can also lead to severe liver damage.

Furthermore, patients who consume three or more alcoholic beverages daily while using this product are at an increased risk of experiencing severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to assess the patient's condition promptly. Monitoring liver function tests and providing supportive care are essential components of management. If severe liver damage is suspected, immediate medical intervention should be sought to mitigate potential complications.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to 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

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

Additionally, excitability has been reported, particularly in children, along with marked drowsiness. Users are cautioned to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Caution is recommended when driving or operating machinery.

Users are advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness; if pain or cough worsens or persists beyond 7 days; if new symptoms arise; if fever worsens or lasts more than 3 days; if redness or swelling occurs; or if cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious condition.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients about the risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be cautioned against using this medication in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a medication contains acetaminophen, they should consult a doctor or pharmacist for clarification.

Additionally, patients must be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

It is critical to advise patients not to use this medication to induce sleep in children. Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain or cough worsens or persists beyond seven days; if new symptoms arise; if fever worsens or lasts more than three days; if redness or swelling occurs; or if a cough returns or is accompanied by a rash or headache lasting longer than usual, as these may indicate a serious condition.

While using this product, patients should be reminded not to exceed the recommended dosage, as excitability may occur, particularly in children. Marked drowsiness may also be a side effect, and patients should avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution should be exercised when driving or operating machinery.

Patients taking the blood-thinning medication warfarin should be advised to consult their doctor or pharmacist before using this product. Similarly, those taking sedatives or tranquilizers should also seek guidance from their healthcare provider prior to use.

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

Patients should be informed that the product is administered orally. Clinicians are advised to counsel patients to consult a doctor or pharmacist prior to use if they are taking warfarin, sedatives, or tranquilizers. While using the product, patients should adhere to the directed dosage, as excitability may occur, particularly in children, and marked drowsiness is possible. It is recommended to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution is advised when driving or operating machinery.

Patients with specific medical conditions, such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or those experiencing urinary issues due to an enlarged prostate, should seek medical advice before use. Additionally, patients should stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness, if pain or cough worsens or persists beyond 7 days, if new symptoms arise, if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if a cough returns with a rash or headache that lasts.

Drug Information (PDF)

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

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