Acetaminophen/Dextromethorphan hydrobromide/Phenylephrine hydrochloride

Description

SPL Code 34089-3 corresponds to a formulation indicated for the management of symptoms associated with daytime cold and flu. This product is designed to alleviate discomfort while allowing for continued daily activities.

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 mentioned in the available data.

Dosage and Administration

Patients should take the medication 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 medication is not recommended for use in children under 4 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is any doubt about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Furthermore, it is essential to adhere to the recommended dosage and not exceed the directed amount.

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 warranted if patients are concurrently using other medications containing acetaminophen, consuming three or more alcoholic drinks daily, or have pre-existing liver conditions.

Acetaminophen may also induce severe skin reactions. Symptoms such as skin reddening, blisters, or rash should prompt immediate cessation of the product and urgent medical evaluation.

In cases of severe sore throat that persists beyond two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to seek medical attention promptly.

General precautions should be communicated to patients, including the necessity of consulting a healthcare provider prior to use if they have a history of liver disease, heart disease, thyroid disease, diabetes, high blood pressure, urinary difficulties due to an enlarged prostate, or a persistent cough associated with excessive phlegm or chronic conditions such as smoking, asthma, or emphysema. Additionally, patients taking the anticoagulant warfarin should consult a healthcare professional or pharmacist before using this product.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or insomnia; 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 underlying 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. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious if they experience a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, as these symptoms warrant prompt medical consultation.

Patients are advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Furthermore, if symptoms worsen or persist beyond five days in children or seven days in adults, or if fever worsens or lasts more than three days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache that lasts may indicate a serious condition, necessitating immediate medical evaluation.

Drug Interactions

Concurrent use of this product with any other medication containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease should consult a healthcare professional before using this product. This consultation is also advised for patients who have discontinued MAOI therapy within the past two weeks, as interactions may still pose a risk during this period.

Additionally, individuals on the anticoagulant warfarin should seek guidance from a healthcare provider prior to using this product, as there may be an increased risk of bleeding or other adverse effects associated with the combination. Monitoring of coagulation parameters may be warranted in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Cold and Flu Relief. 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. For patients 12 years and older, the recommended dosage is 2 softgels with water every 4 hours, with a maximum of 4 doses in a 24-hour period.

If symptoms worsen or persist beyond 5 days in children, or 7 days in adults, it is advised to discontinue use and seek medical advice.

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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 drug 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed four doses within a 24-hour period, as this represents the maximum daily amount for this product. Additionally, patients should avoid concurrent use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, it is recommended that patients limit alcohol consumption to fewer than three alcoholic drinks per day while using this product to mitigate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

Overdosage

Taking more than the recommended dosage of this medication can lead to serious health complications. It is imperative that healthcare professionals remain vigilant regarding the potential risks associated with overdosage.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt intervention is crucial, as the severity of symptoms may not be immediately apparent.

Both adults and children are at risk, and quick medical attention is essential, even in the absence of noticeable signs or symptoms. This proactive approach can significantly mitigate the potential adverse effects associated with an 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. 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 advised that the use of the product be discontinued immediately, and medical assistance should be sought without delay.

Patient Counseling

Healthcare providers should advise patients to adhere strictly to the recommended dosage, as taking more than directed can lead to serious health complications. In the event of an overdose, patients must seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should stop use and seek medical advice if their symptoms worsen or persist beyond 5 days for children or 7 days for adults. If a fever intensifies or lasts more than 3 days, or if there is any redness or swelling, patients should also stop use and consult a healthcare professional. New symptoms that arise should prompt a discussion with a doctor, as should a recurrence of cough, particularly if accompanied by a rash or a headache that persists.

It is important for patients to consult with their healthcare provider before using the medication if they have a history of liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Patients with a cough that produces excessive phlegm or those with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice prior to use. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in blister packaging. Each blister unit must be inspected prior to use; do not use if the blister unit is torn or open.

For optimal storage, the product should be maintained at room temperature, specifically within the range of 20-25 °C (68-77 °F). Proper handling and storage conditions are essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is crucial to inform patients that exceeding the recommended dosage can lead to serious health issues. In the event of an overdose, immediate medical assistance should be sought, and patients are encouraged to contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)