Pentrexcilina Adult 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

Patients should adhere strictly to the recommended dosage and administration guidelines to ensure safety and efficacy. The maximum dosage should not exceed the specified limits, and healthcare professionals should be aware of the overdose warning associated with this medication.

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 the dosing cup is used exclusively for this medication and not with any other products to avoid dosing errors.

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

Healthcare professionals should counsel patients to refrain from taking more than 6 doses within a 24-hour period to prevent potential adverse effects.

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 treatment. MAOIs are commonly prescribed for depression, psychiatric, or emotional conditions, as well as for Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Additionally, it is essential to adhere to the recommended dosage to avoid 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.

It is imperative to exercise caution when prescribing this product. Patients should be instructed not to use it alongside any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a healthcare provider or pharmacist for clarification. Additionally, this product is contraindicated for children under 12 years of age.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson’s disease should not use this product. Furthermore, it should not be used for at least 2 weeks following the discontinuation of an MAOI. If patients are unsure whether their prescription includes an MAOI, they should seek guidance from a healthcare professional.

Healthcare providers should monitor patients for specific symptoms that warrant discontinuation of the product and further medical evaluation. Patients should be advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; 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; if new symptoms develop; or if a cough recurs with fever, rash, or headache that persists. These symptoms may indicate a serious underlying condition requiring prompt medical attention.

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 further 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 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), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. This contraindication extends for a period of two weeks following the discontinuation of the MAOI.

Patients who are prescribed 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 warranted to ensure safe and effective use.

Packaging & NDC

Below are the non-prescription pack sizes of Pentrexcilina Adult 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 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 prescribing to pediatric patients, as safety and efficacy have not been established in those younger than 12 years.

Geriatric Use

There is no specific information available 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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 recommended dosage 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 and to mitigate the risk of potential hepatotoxicity.

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 medical help without delay is crucial for effective management. Quick medical attention is essential, even in the absence of noticeable signs or symptoms, to mitigate potential complications and ensure appropriate treatment is administered.

Healthcare providers should remain vigilant and prepared to assess and manage any cases of overdose, emphasizing the importance of early intervention in safeguarding patient health.

Nonclinical Toxicology

No teratogenic effects have been observed in the studies conducted. Additionally, there are no reported non-teratogenic effects. The available data does not provide any specific details regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of acetaminophen. Notably, severe skin reactions have been reported, which include symptoms such as 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 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 check with their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness. They should also be advised to discontinue use and consult a doctor 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 fever, rash, or a headache that lasts, as these may indicate a serious condition.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and inform patients about the 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 product. 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 should be reminded 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 encouraged to discuss their use of this product with a doctor or pharmacist.

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). It is important to note that refrigeration is not permitted. To ensure proper handling and storage, the carton should be retained for reference to the complete Drug Facts.

Additional Clinical Information

The medication is administered orally, with a recommended dose of 20 mL in the provided dosing cup every 4 hours for adults and children aged 12 years and older. Clinicians should advise patients to consult a health professional if they are pregnant or breastfeeding. 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 Pentrexcilina Adult Total Relief Multi-Symptom, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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