Agrifen

Description

AGRIFEN is a combination medication containing Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, and Phenylephrine HCl 5 mg. Each package contains 10 soft gels. The product is exclusively distributed by OPMX, located in Chula Vista, CA 91910. The National Drug Code (NDC) for AGRIFEN is 69729-802-10. The product features a tamper-evident packaging; it should not be used if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. For inquiries, the contact number is 619-600-5632.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates nasal congestion, cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, and fever.

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

Dosage and Administration

The medication should be taken only as directed. For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, not to exceed 4 doses within a 24-hour period.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing recommendations. The use of this medication is not recommended for children under 4 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.

• In cases where there is uncertainty regarding the presence of acetaminophen in other medications; consultation with a healthcare professional is advised.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as this may lead to serious drug interactions. If there is uncertainty about the presence of an MAOI in a prescription drug, a healthcare professional should be consulted prior to 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 maximum daily dosage of 4 doses within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications containing acetaminophen or consuming three or more alcoholic beverages daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

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 advised to consult a physician promptly.

General precautions should be taken for patients with pre-existing conditions. Healthcare providers should recommend that patients consult a doctor prior to use if they have liver disease, heart disease, diabetes, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Additionally, patients with a persistent or chronic cough due to smoking, asthma, chronic bronchitis, or emphysema should seek medical advice before using this product. It is also advisable for patients taking the anticoagulant warfarin to consult with a healthcare professional or pharmacist prior to use.

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. They should also seek medical advice if symptoms worsen or persist beyond 5 days for children or 7 days for adults, if fever worsens or lasts more than 3 days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs or is accompanied by a rash or headache lasting longer than expected, as these may indicate a serious condition.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed the maximum daily dosage of four doses within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider promptly.

Patients should stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness, if symptoms worsen or persist beyond five days for children or seven days for adults, if fever worsens or lasts more than three days, if redness or swelling is present, if new symptoms arise, or if a cough recurs with a rash or headache that lasts, as these may indicate a serious condition.

Before using this product, patients with liver disease, heart disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland should consult a healthcare provider. Those experiencing a cough with excessive phlegm or a persistent cough associated with smoking, asthma, chronic bronchitis, or emphysema should also seek medical advice. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

An overdose of this product can lead to serious health complications. In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

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), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be used for at least two weeks following the discontinuation of an MAOI to avoid potential hypertensive crises.

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 warranted to ensure safe use and to mitigate the risk of increased bleeding.

Packaging & NDC

Below are the non-prescription pack sizes of Agrifen (acetaminophen, dextomethorphan hydrobromide, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The product is not recommended for children under 4 years of age.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is crucial for patients to adhere to the following guidelines to minimize this risk:

• Patients must not exceed 4 doses within a 24-hour period, as this is the maximum daily amount for this product.

• Caution is advised against the concurrent use of other medications containing acetaminophen, as this may lead to unintentional overdose and increased risk of liver damage.

• Patients who consume 3 or more alcoholic drinks daily should avoid using this product, as alcohol can exacerbate the potential for liver injury.

Before using this product, patients with a history of liver disease should consult a healthcare professional to assess the appropriateness of use and to discuss any necessary monitoring or dosage adjustments.

Overdosage

In cases of overdosage, taking more than the recommended dose can lead to serious health complications. It is imperative that individuals seek immediate medical assistance or contact a Poison Control Center without delay if an overdose is suspected.

Importance of Prompt Medical Attention

Quick medical intervention is crucial for both adults and children. Even in the absence of noticeable signs or symptoms, the potential for serious health issues necessitates that healthcare professionals remain vigilant and proactive in managing overdose situations.

Healthcare providers are advised to assess the situation thoroughly and initiate appropriate management procedures as soon as possible to mitigate any adverse effects associated with the overdose.

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 associated with the use of the product. Severe skin reactions have been reported, characterized by symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the product be discontinued immediately and medical assistance sought.

Additionally, new symptoms that arise following the use of the product may indicate a serious condition. Reports have included nervousness, dizziness, and sleeplessness. It is recommended that individuals consult a healthcare professional if symptoms worsen or persist beyond specified durations—5 days for children and 7 days for adults.

Concerns should also be raised if fever persists or worsens beyond 3 days. The presence of redness or swelling should prompt discontinuation of the product and consultation with a healthcare provider. Furthermore, if a cough returns or occurs alongside a rash or headache that lasts, this may suggest a serious condition requiring medical evaluation.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed not to use this product in conjunction with any other medication 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 for clarification.

It is crucial to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. Patients should be advised to seek guidance from a healthcare professional if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop using the product and seek medical advice if their symptoms worsen or persist beyond 5 days for children or 7 days for adults. If a fever worsens or lasts more than 3 days, or if there is any redness or swelling, patients should also be directed to contact their healthcare provider. New symptoms or a recurrence of cough, especially if accompanied by a rash or persistent headache, 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 dosage. It is important for patients to consult a doctor before using this medication if they have any of the following conditions: liver disease, heart disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Patients with a cough that produces excessive phlegm or a persistent cough related to smoking, asthma, chronic bronchitis, or emphysema should also seek medical advice prior to use. Lastly, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)