Rompe Pecho

Description

The provided information does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available data. Further information is required to create a comprehensive description.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, headache, nasal congestion, sore throat, runny nose, sneezing, cough, and sinus congestion and pressure. It aids in clearing nasal passages and provides relief from cough to facilitate sleep. Additionally, this drug temporarily reduces fever.

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage and administration guidelines. The product should not be taken in excess of the directed amount, and a maximum of 6 doses is permitted within a 24-hour period.

Prior to administration, the product must be shaken well. It is essential to measure the dosage using the dosing cup provided; no other dosing device should be utilized. The product's color and flavor may vary due to the natural honey content.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours as needed. The product is not indicated for use in children under 12 years of age.

It is important to keep the dosing cup with the product to ensure accurate measurement and administration.

Contraindications

Use is contraindicated in individuals who are unable to keep the product out of reach of children. This precaution is necessary to prevent accidental ingestion or misuse by pediatric patients. No other contraindications have been identified.

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, which is a maximum of 6 doses in 24 hours. Patients should be cautioned against using this product in conjunction with other medications containing acetaminophen, as well as against consuming 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also cause severe skin reactions, including symptoms such as skin reddening, blisters, and rash. If any of these symptoms occur, patients must be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a healthcare professional. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping such medication. Patients should be advised to inquire with their doctor or pharmacist if they are unsure about the presence of an MAOI in their prescription drugs. Furthermore, this product is not intended to induce sleep in children.

Patients should seek medical advice before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, difficulty urinating due to an enlarged prostate gland, a cough that produces excessive phlegm, or a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Those on a sodium-restricted diet should also consult a healthcare professional prior to use.

It is essential for patients to consult a doctor or pharmacist before using this product if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin. While using this product, patients should be advised to follow the dosing instructions carefully, as excitability may occur, particularly in children. Marked drowsiness may also be experienced, and patients should be cautioned to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can exacerbate drowsiness. Caution is advised when driving or operating machinery.

In the event of an overdose, patients should seek emergency medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, 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 is observed; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious condition requiring medical evaluation.

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 of severe sore throat that 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.

While using this product, excitability may occur, particularly in children, and marked drowsiness is also a possibility. Patients are cautioned to avoid alcoholic beverages, as the combination of alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Care should be taken when driving or operating machinery.

Patients should discontinue 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 new symptoms arise; if fever worsens or persists for more than three days; if redness or swelling is observed; or if a cough recurs or occurs with a rash or headache lasting longer than usual, as these 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 to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

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 commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. The combination may lead to serious adverse effects.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as these substances may enhance drowsiness and sedation.

Additionally, individuals on the anticoagulant warfarin should seek advice from a healthcare provider before using this medication. The interaction may increase the risk of bleeding due to potential alterations in warfarin metabolism or effects.

Caution is advised when consuming alcohol, as it may further increase drowsiness when taken with this medication, particularly in conjunction with sedatives or tranquilizers. Monitoring for increased sedation and potential respiratory depression is recommended in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Rompe Pecho (acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl). 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. Children in this age group should not use this medication.

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 use. It is important to assess the potential risks and benefits associated with the use of this medication during pregnancy and lactation. Additionally, this product should be kept out of reach of children to prevent accidental ingestion or exposure.

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 individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 be advised of the potential risks associated with the use of this product, which contains acetaminophen. Severe liver damage may occur if patients exceed 6 doses within a 24-hour period, which is the maximum daily amount, or if they concurrently use other medications containing acetaminophen. Additionally, consumption of 3 or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

It is recommended that patients with liver disease consult a healthcare professional prior to using this product. In the event of an overdose, which may result from taking more than the recommended dose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dose is exceeded. It is imperative that healthcare professionals remain vigilant regarding the signs and symptoms of overdose, as these may not always be immediately apparent.

Recommended Actions In the case of suspected overdose, it is crucial to seek medical assistance promptly. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay. Quick medical intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Management Procedures Upon recognition of an overdose, immediate evaluation and management by healthcare professionals are necessary. Monitoring liver function and assessing for any signs of hepatic impairment should be prioritized. The management plan may include supportive care and specific interventions based on the clinical presentation and severity of the overdose.

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

Acetaminophen has been associated with severe skin reactions reported in postmarketing experience. Symptoms of these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a configuration that includes a dosing cup, which must be kept with the product. 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 should be shaken well. For accurate dosing, it is important to measure only with the dosing cup provided. The dosing cup should be discarded after the product is opened to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 30 mL every 4 hours for adults and children aged 12 years and older. It is contraindicated for children under 12 years of age. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the medication out of reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

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