Phenylephrine hydrochloride/Acetaminophen/Dextromethorphan hydrobromide

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 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 8 Softgels within a 24-hour period.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing. 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, is prohibited. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. This includes a restriction on use for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

• Additionally, the product should not be used in excess of the directed dosage.

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 8 Softgels in a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications that contain acetaminophen or if they consume three or more alcoholic drinks daily while using this product.

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

In cases of severe sore throat, particularly if it 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.

Emergency medical help should be sought in the event of an overdose. Patients or caregivers should be instructed to contact a Poison Control Center immediately, as timely medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and contact their healthcare provider if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than seven days; fever that worsens or persists beyond three days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache lasting for an extended period. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 8 Softgels 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.

Patients should discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than seven days; if fever worsens or persists for more than three days; if redness or swelling is observed; if new symptoms arise; or if a cough recurs or occurs alongside a rash or headache that lasts, as these may indicate a serious condition.

Prior to using this product, patients should seek medical advice if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Additionally, those with a cough that produces excessive phlegm or a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should consult a healthcare provider.

Patients taking the blood-thinning medication warfarin should also consult a doctor or pharmacist before using this product.

Drug Interactions

Concurrent use of this medication with any other product containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of severe liver damage.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as it may elevate the risk of bleeding. Monitoring of coagulation parameters may be warranted in such cases to ensure patient safety.

No additional drug interactions or laboratory test interactions have been identified.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen, Dextromethorphan Hydrobromide and 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 medication is not recommended for children under 4 years of age. For adolescents and adults aged 12 years and older, the recommended dosage is 2 Softgels taken with water every 4 hours, with a maximum of 8 Softgels in a 24-hour period.

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 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

There is no specific information 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 critical to adhere to the maximum daily dosage of 8 Softgels within a 24-hour period, as exceeding this limit may result in severe liver damage.

Additionally, patients must be cautioned against the concurrent use of other medications containing acetaminophen, as this can also lead to severe liver damage.

Furthermore, individuals who consume three or more alcoholic drinks daily should exercise extreme caution, as the risk of severe liver damage is significantly heightened when using this product in conjunction with alcohol. Regular assessment of liver function may be warranted in patients with compromised liver health to ensure safety and efficacy.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient’s condition is critical. Recommended actions include:

1. Assessment: Conduct a thorough evaluation of the patient, including vital signs and level of consciousness.

2. Supportive Care: Initiate supportive measures as necessary, which may involve airway management, oxygen supplementation, and intravenous fluids.

3. Toxicology Consultation: Consider consulting a poison control center or a toxicologist for guidance on specific management strategies tailored to the substance involved.

4. Monitoring: Continuous monitoring of the patient’s vital signs and clinical status is crucial to detect any deterioration promptly.

It is imperative that healthcare professionals document all findings and interventions meticulously to ensure comprehensive care and facilitate any necessary follow-up.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Similarly, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Additionally, there is no information regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may manifest as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

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 attention is crucial for both adults and children, even if no signs or symptoms are initially 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 with a doctor or pharmacist.

It is essential to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the past two weeks. Patients should be advised to verify with their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients should be counseled to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be advised to seek medical advice if pain, nasal congestion, or cough worsens or persists beyond seven days, or if fever intensifies or lasts more than three days. They should also be instructed to stop use and contact a healthcare professional if they notice any redness or swelling, if new symptoms arise, or if a cough recurs or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients must be reminded to adhere strictly to the recommended dosage and not exceed the directed amount.

Healthcare providers should encourage patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients should also be advised to seek medical guidance if they have a cough associated with excessive phlegm or a persistent or chronic cough related to smoking, asthma, or emphysema. Furthermore, patients taking the blood-thinning medication warfarin should be instructed to consult a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 15° to 25°C (59° to 77°F) to maintain its integrity and efficacy. Proper container requirements must be adhered to, ensuring that the product is kept in its original packaging. Special handling needs include protection from excessive heat and moisture to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)