Pentrexcilina Children Total Relief Multi-Symptom

Description

PENTREXCILINA is a pharmaceutical formulation that includes the active ingredients acetaminophen, dextromethorphan HBr, phenylephrine HCl, and guaifenesin. This product is presented in a liquid dosage form, with a total volume of 6 fluid ounces (177 milliliters). It is manufactured in facilities registered with the FDA in the United States.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, 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 bothersome mucus and making coughs more productive.

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 maximum dosage should not exceed the specified limits, and patients should be cautioned against taking more than 6 doses within a 24-hour period.

Dosing should be measured exclusively with the dosing cup provided with the medication. It is imperative that this dosing cup is not used for any other products to ensure accurate measurement.

For children aged 6 to under 12 years, the recommended dose is 10 mL (equivalent to 2 teaspoons) administered every 4 hours as needed. For children under 6 years of age, the use of this medication is not recommended.

Healthcare professionals should ensure that patients understand these guidelines to promote safe and effective use of the medication.

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. 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 treatment. MAOIs are used for certain psychiatric or emotional conditions and Parkinson's disease, and their interaction with this product may lead to serious adverse effects. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is recommended.

• Exceeding the recommended dose is contraindicated due to the risk of overdose.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that exceeding 6 doses within a 24-hour period, taking this product in conjunction with other medications containing acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product significantly increases the risk of liver injury.

General precautions must be observed when administering this product. It is contraindicated for use with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should be encouraged to consult a healthcare provider or pharmacist if they are uncertain about the presence of acetaminophen in their medications. Additionally, this product is not recommended for children under 12 years of age. It is also contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. Patients should seek clarification from a healthcare professional if they are unsure whether their prescription includes an MAOI.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. They should also seek medical advice if pain, nasal congestion, or cough worsens or persists beyond 7 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs, or if new symptoms develop. A return of cough, particularly when accompanied by fever, rash, or a persistent headache, may indicate a serious condition requiring immediate 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. An overdose, defined as taking more than the recommended dose, can also lead to liver damage. In the event of an overdose, it is imperative for patients to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is critical even if no signs or symptoms are initially apparent.

Patients are advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if fever intensifies or lasts more than three days, medical advice should be sought. The presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or occurs alongside fever, rash, or headache that lasts may indicate a serious condition requiring medical evaluation.

Before using this product, patients should consult a healthcare provider if they have a history of liver disease, heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Those with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, or a cough accompanied by excessive phlegm (mucus) should also seek medical advice prior to use.

Furthermore, patients taking the blood-thinning medication warfarin or those on a sodium-restricted diet should consult a doctor or pharmacist before using this product to ensure safety and avoid potential interactions.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be administered for at least two weeks following the discontinuation of an MAOI, as this may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to avoid potential interactions that could increase the risk of bleeding.

Packaging & NDC

Below are the non-prescription pack sizes of Pentrexcilina Children Total Relief Multi-Symptom (acetaminophen, dextromethorphan hydrobromide, guaifenesin usp, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should not use this medication. For children aged 6 to under 12 years, the recommended dosage is 10 mL (2 teaspoonfuls) every 4 hours, with a maximum of 6 doses in a 24-hour period. It is important to keep this medication out of reach of children to prevent accidental ingestion.

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 adverse effects or changes in therapeutic response, 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 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 the safety of both the mother and the developing fetus.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily amount of 6 doses within a 24-hour period. Additionally, patients should avoid concomitant use of other medications that contain acetaminophen, as this can further increase the risk of liver injury.

Furthermore, patients with compromised liver function are advised to limit alcohol consumption to fewer than 3 alcoholic drinks daily while using this product. Monitoring of liver function may be warranted in patients with existing liver conditions or those who are at increased risk for hepatic impairment. Regular assessment of liver enzymes and overall liver health is recommended to ensure patient safety.

Overdosage

In the event of an overdose, defined as the ingestion of more than the recommended dose, there is a significant risk of liver damage. Healthcare professionals should be aware that the severity of the effects may not be immediately apparent, as symptoms can be delayed or absent initially.

It is imperative that individuals who suspect an overdose seek medical assistance promptly. Contacting a Poison Control Center or obtaining immediate medical help is crucial to ensure appropriate management and intervention. Quick medical attention is essential, even in the absence of noticeable signs or symptoms, to mitigate potential complications and facilitate timely treatment.

Healthcare providers should remain vigilant and prepared to assess and manage any cases of overdose, prioritizing patient safety and the prevention of serious health consequences.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, the assessment of potential risks related to these aspects remains incomplete.

Postmarketing Experience

Postmarketing experience has indicated that acetaminophen may be associated with severe skin reactions. These reactions can manifest as symptoms including skin reddening, blisters, and rash. In the event of a skin reaction, it is recommended that the use of acetaminophen be discontinued immediately, and medical assistance should be sought without delay.

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 medication is not recommended for children under 12 years of age. Additionally, patients should be cautioned against using this product 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 check with a healthcare professional if they are unsure whether their prescription includes an MAOI.

Patients should be instructed to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. They should also be advised to stop using the medication and consult a doctor if pain, nasal congestion, or cough worsens or persists for more than 7 days, or if fever worsens or lasts more than 3 days. Any signs of redness or swelling, the emergence of new symptoms, or a cough that returns or occurs with fever, rash, or a headache that lasts should prompt patients to seek medical attention, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dose, and they should be made aware of the overdose warning. Patients with liver disease, heart disease, diabetes, thyroid disease, high blood pressure, or those who have trouble 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 that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Patients experiencing a cough with excessive phlegm should be encouraged to consult a healthcare professional.

Lastly, patients taking the blood-thinning medication warfarin or those on a sodium-restricted diet should be advised to discuss their use of this product with a doctor or pharmacist before proceeding.

Storage and Handling

The product is supplied in a carton that contains essential Drug Facts. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. It is important to note that refrigeration is not permitted, as this may compromise the product's integrity. Users are advised to retain the carton for reference to the complete Drug Facts.

Additional Clinical Information

The medication is administered orally, with a recommended dose of 10 mL (or 2 teaspoons) for children aged 6 to under 12 years, to be given every 4 hours. Clinicians should advise patients to consult a health professional if they are pregnant or breastfeeding before use. Additionally, it is important to keep the medication out of reach of children to ensure safety. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Pentrexcilina Children Total Relief Multi-Symptom, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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