Acetaminophen 325mg, Dextromethorphan Hbr 10mg and Phenyleprine Hcl 5mg

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or influenza. Specifically, it alleviates minor aches and pains, headache, cough, sore throat, and nasal and sinus congestion. Additionally, it temporarily reduces fever.

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

Dosage and Administration

Adults and children aged 12 years and over are advised to take 2 capsules with water every 4 hours as needed. The total daily dosage must not exceed 10 capsules within a 24-hour period, unless otherwise directed by a healthcare professional.

Use of this medication is not recommended for children under 12 years of age. It is imperative that patients adhere to the recommended dosing guidelines and avoid exceeding the specified limits to ensure safety and efficacy.

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.

• History of allergic reaction to this product or any of its ingredients, which may result in severe hypersensitivity reactions.

• In children under 12 years of age, due to safety concerns and lack of established efficacy in this population.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is essential to monitor patients for signs of liver dysfunction, particularly in those with a history of alcohol use or pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin or allergic reactions. Symptoms to be vigilant for include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. Should any of these symptoms manifest, patients must be advised to discontinue use immediately and seek medical assistance.

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

Emergency Medical Help In the event of an overdose, it is critical to seek emergency medical help or contact a Poison Control Center without delay. Quick medical intervention is vital for both adults and children, even if no immediate signs or symptoms are apparent.

Discontinuation and Consultation Patients should be advised to stop taking this product and consult a healthcare provider if any of the following occur: pain, cough, or nasal congestion worsens or lasts longer than seven days; fever worsens or persists beyond three days; redness or swelling is observed; new symptoms develop; cough recurs or is accompanied by a rash or headache that lasts; or if nervousness, dizziness, or sleeplessness occurs. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of potential adverse reactions, including serious warnings related to liver damage and allergic reactions.

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin or allergic reactions. Symptoms of such reactions can include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, as they should consult a doctor promptly.

It is recommended that patients stop use and consult a healthcare professional if pain, cough, or nasal congestion worsens or lasts longer than seven days; if fever worsens or lasts more than three days; if redness or swelling is present; if new symptoms occur; or if a cough returns or occurs with a rash or headache that persists. Symptoms such as nervousness, dizziness, or sleeplessness should also prompt a consultation with a doctor.

Before using this product, patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a cough with excessive phlegm, difficulty urinating due to prostate enlargement, or a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema) should seek medical advice. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may necessitate careful monitoring due to potential alterations in anticoagulant effects.

Additionally, it is advised that this medication not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. This precaution is essential to avoid the risk of acetaminophen overdose, which can lead to serious liver damage.

Currently, there are no specific drug interactions or laboratory test interactions reported for this medication. However, ongoing monitoring and consultation with healthcare providers are recommended to ensure safe and effective use.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen 325mg, Dextromethorphan Hbr 10mg and Phenyleprine Hcl 5mg (acetaminophen, dextromethorphan hbr and phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. There are no established safety or efficacy profiles for this age group, and the use of this medication in children under 12 is contraindicated. Healthcare professionals are advised to consider alternative treatments for pediatric patients in this age range.

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 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 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 this patient population.

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 if the total daily dosage of acetaminophen exceeds 4,000 mg within a 24-hour period. Additionally, the risk of liver damage increases if patients take other medications containing acetaminophen or consume three or more alcoholic drinks daily while using this product.

Due to these risks, patients with compromised liver function are advised to adhere strictly to the recommended dosage and to avoid concurrent use of other acetaminophen-containing products. Regular assessment of liver function may be warranted in these patients to ensure safety and prevent potential adverse effects.

Overdosage

In cases of acetaminophen overdosage, severe liver damage may occur if an individual ingests more than 4,000 mg within a 24-hour period. This threshold is critical, as exceeding it significantly increases the risk of hepatotoxicity.

Healthcare professionals are advised to seek emergency medical assistance immediately if an overdose is suspected or if the patient exhibits severe symptoms. Prompt intervention is essential to mitigate potential complications associated with acetaminophen overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include severe skin reactions such as skin reddening, blisters, rash, hives, and facial swelling. Additionally, cases of allergic reactions have been noted, including asthma characterized by wheezing and instances of shock.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

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 about the presence of acetaminophen in their medications, they should be encouraged to consult a doctor or pharmacist.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson's disease, or within two weeks of discontinuing an MAOI. Patients should be advised to verify with a healthcare professional if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Additionally, this product is not recommended for children under 12 years of age.

Healthcare providers should instruct patients to discontinue use and consult a doctor if pain, cough, or nasal congestion worsens or persists beyond seven days, if fever intensifies or lasts more than three days, if redness or swelling occurs, or if new symptoms develop. Patients should also be advised to seek medical attention if a cough recurs or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

Patients should be informed to stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness. It is essential to emphasize that patients must not exceed the recommended dosage while using this product.

Before initiating treatment, patients should be encouraged to consult a doctor if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, cough with excessive phlegm, difficulty urinating due to prostate enlargement, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Furthermore, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is kept away from excessive heat, particularly temperatures exceeding 40ºC (104ºF). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Acetaminophen 325mg, Dextromethorphan Hbr 10mg and Phenyleprine Hcl 5mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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