Daytime Severe Cold and Flu

Description

No specific information related to the Description section for SPL code 34089-3 is provided in the text.

Uses and Indications

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

Additionally, this drug reduces swelling of the nasal passages and temporarily restores freer breathing through the nose. It promotes nasal and/or sinus drainage and assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of bothersome mucus and enhancing the productivity of coughs.

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

Dosage and Administration

The medication should be taken only as directed, and the maximum dosage should not exceed 8 softgels within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours as needed.

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

There are no specific contraindications associated with this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed the maximum daily dosage of 8 softgels within a 24-hour period, combine this product with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients must 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 instructed to consult a physician without delay.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their other medications, they should be advised to consult a healthcare professional. Additionally, this product is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have taken an MAOI within the past two weeks. Patients should be encouraged to verify with their healthcare provider or pharmacist if they are unsure about their medications.

Healthcare professionals should recommend that patients 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, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Furthermore, patients taking the anticoagulant warfarin should consult a healthcare professional before using this product.

Patients must adhere strictly to the recommended dosage and should be instructed to stop use and seek medical advice if they experience nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or cough lasting more than seven days. They should also seek medical attention if fever worsens or persists beyond three days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs with a rash or headache lasting for an extended period, as these may indicate a serious condition.

In the event of an overdose, immediate medical assistance should be sought, or patients should contact a Poison Control Center without delay.

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 where a sore throat is severe, 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 also stop use and seek medical advice 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 occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

Drug Interactions

Co-administration 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), which includes certain medications for depression, psychiatric disorders, 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 or other serious adverse effects.

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

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Severe Cold and Flu (acetaminophen, dextromethorphan hydrobromide, guaifenesin, 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 prior to use. The product is not recommended for children under 4 years of age.

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, 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 drug 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• The maximum recommended dosage is 8 softgels in a 24-hour period. Exceeding this dosage may lead to severe liver damage.

• Patients should avoid concomitant use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

• Consumption of 3 or more alcoholic drinks per day while using this product is contraindicated, as it may exacerbate the potential for liver damage.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in patients with compromised liver function to detect any potential adverse effects promptly.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert to the signs of overdose and to act swiftly to ensure patient safety and optimal outcomes.

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

There have been reports of severe skin reactions associated with acetaminophen, including symptoms such as skin reddening, blisters, and rash. In cases where a skin reaction occurs, users are advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in packaging that ensures its integrity during storage and handling. It should be stored at a temperature range of 20-25°C (68-77°F). Care must be taken to protect the product from light, heat, and moisture to maintain its efficacy and safety.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours. For children aged 4 to under 12 years, it is advised to consult a doctor before use. The medication is not recommended for children under 4 years of age.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)