Daytime Cold and Flu Multi-Symptom Relief

Description

AUROHEALTH is a multi-symptom relief formulation indicated for the management of cold and flu symptoms. Each capsule contains a combination of active ingredients: acetaminophen (325 mg), dextromethorphan hydrobromide (10 mg), and phenylephrine hydrochloride (5 mg). The product is designed for non-drowsy daytime relief and is available in a dosage form of capsules. Each package contains 16 capsules. The formulation is comparable to the active ingredients found in VICKS® DayQuil® Cold & Flu Multi-Symptom Relief LiquiCaps®. The National Drug Code (NDC) for this product is 58602-768-15.

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

Patients should take the medication only as directed, adhering to the overdose warning. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two capsules taken with water every four hours.

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

When using other daytime or nighttime products, it is essential to carefully read each label to ensure correct dosing and avoid exceeding the recommended limits.

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. 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 prohibition on use for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty about whether a prescription medication contains an MAOI, a healthcare professional should be consulted prior to using this product.

• It is also advised to adhere strictly to the recommended dosage and not exceed the directed amount when using this product.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the specified guidelines. Healthcare professionals should advise patients to adhere strictly to the following recommendations to mitigate this risk:

Liver Warning Patients must not exceed 4 doses within a 24-hour period, as this is the maximum daily amount for this product. Caution is also warranted when prescribing this medication in conjunction with other drugs that contain acetaminophen. Additionally, patients should be advised against consuming 3 or more alcoholic drinks daily while using this product, as this can further increase the risk of liver damage.

Sore Throat Warning In cases of severe sore throat that persists for more than 2 days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to seek medical attention promptly.

General Precautions Healthcare providers should emphasize the importance of adhering to the recommended dosage to prevent overdose, which can lead to serious health complications. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Quick medical intervention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Monitoring and Follow-Up Patients should be advised to discontinue use and consult a healthcare professional if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening symptoms that last beyond 5 days in children or 7 days in adults; fever that worsens or persists for more than 3 days; any signs of redness or swelling; the emergence of new symptoms; or a cough that recurs or is accompanied by a rash or headache that lasts. 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, particularly those related to liver health and severe throat conditions. The product contains acetaminophen, which can lead to severe liver damage if the maximum daily dosage of 4 doses within 24 hours is exceeded, if it is taken concurrently with other medications containing acetaminophen, or if consumed with three or more alcoholic drinks daily.

In the event of a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to seek medical attention promptly.

Patients should discontinue use and consult a healthcare professional if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, 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. Signs of serious conditions may also include the presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache.

Before using this product, patients with pre-existing conditions such as liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or urinary difficulties due to an enlarged prostate gland should consult a healthcare provider. Furthermore, individuals experiencing a cough with excessive phlegm or a persistent cough associated with smoking, asthma, or emphysema should also seek medical advice prior to use.

Patients taking the anticoagulant warfarin should consult a doctor or pharmacist before using this product to avoid potential interactions.

Drug Interactions

Concomitant use of this medication with any other drug 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) for depression, psychiatric or emotional conditions, or Parkinson's disease, as well as for a period of two weeks following the discontinuation of an MAOI. The combination may lead to serious and potentially life-threatening interactions.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to avoid potential alterations in the anticoagulant effect.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Cold and Flu Multi-Symptom Relief (acetaminophen, dextromethorphan 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 medication is not recommended for children under 4 years of age. For patients aged 12 years and older, the recommended dosage is 2 capsules with water every 4 hours.

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

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information. 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 therapeutic response, given the variability in drug metabolism and sensitivity that can occur with aging.

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 the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 4 doses within a 24-hour period. Additionally, patients must avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

It is also critical for patients with compromised liver function to limit alcohol consumption. Specifically, the intake of 3 or more alcoholic drinks daily while using this product is contraindicated, as it may exacerbate the potential for severe liver damage. Regular assessment of liver function is recommended for patients with hepatic impairment to ensure safe use of this medication.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product beyond the recommended limits.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if a patient exceeds four doses within a 24-hour period, which is the maximum daily dosage for this product. Additionally, the concomitant use of this product with other medications containing acetaminophen can also lead to severe liver damage.

Furthermore, patients who consume three or more alcoholic beverages daily while using this product are at an increased risk of experiencing severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to assess the patient's liver function and consider immediate medical intervention. Monitoring of liver enzymes and supportive care may be necessary, depending on the severity of the symptoms and the extent of the overdosage. Prompt recognition and management are crucial to mitigate potential complications associated with liver injury.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs.

Allergic reactions have been noted, including cases of anaphylaxis and angioedema. Hepatotoxicity has also been reported, with instances of severe liver injury documented. Skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been observed.

Additionally, cardiovascular events, including hypertension and arrhythmias, have been recorded. Gastrointestinal events, notably nausea and vomiting, have been reported as well. Neurological events, including dizziness and confusion, have also been documented in the postmarketing setting.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the directed dose can lead to serious health problems. In the event of an overdose, patients should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are present.

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 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 last 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 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 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 instructed to stop use and contact a healthcare professional. 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. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: 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 a persistent or chronic cough related to smoking, asthma, or emphysema should also be advised to seek medical guidance prior to use. Lastly, patients taking the blood-thinning medication warfarin should be encouraged to discuss their use of this product with a doctor or pharmacist.

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 to maintain its integrity and efficacy. Proper handling should be observed to ensure optimal conditions are met throughout the storage period.

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 Daytime Cold and Flu Multi-Symptom Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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