Leader Daytime Severe Cold and Flu

Description

Acetaminophen, Dextromethorphan HBr, Guaifenesin, and Phenylephrine HCl are the active ingredients in this formulation, which serves multiple therapeutic purposes including pain relief, fever reduction, cough suppression, expectoration, and nasal decongestion. The product is presented in an 8 fluid ounce (237 mL) dosage form and is characterized by its original flavor. It is formulated to be alcohol-free, ensuring suitability for a wider range of patients.

Uses and Indications

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

Additionally, this drug promotes nasal and/or sinus drainage, helps restore freer breathing through the nose, and aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

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

Dosage and Administration

Patients should adhere strictly to the prescribed dosage and administration guidelines. It is imperative to utilize only the dose cup provided with the medication to ensure accurate dosing.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours, with a maximum of 4 doses within a 24-hour period. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours, also not to exceed 4 doses in a 24-hour timeframe.

For children aged 4 to under 6 years, it is advised to consult a healthcare professional for appropriate dosing recommendations. The medication is not indicated for use in children under 4 years of age.

Healthcare professionals should monitor patients for adherence to these guidelines to prevent the risk of overdose.

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) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease, as the combination may lead to serious adverse effects. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted.

• History of allergic reaction to this product or any of its ingredients, as this may result in severe allergic responses.

Warnings and Precautions

Severe liver damage may occur with the use of this product containing acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly under the following circumstances:

• An adult should not exceed 4,000 mg of acetaminophen within a 24-hour period.

• A child should not take more than 5 doses in a 24-hour period.

• Caution is advised when this product is taken concurrently with other medications containing acetaminophen.

• Adults consuming 3 or more alcoholic beverages daily while using this product are at heightened risk for liver damage.

In addition to liver-related concerns, healthcare providers should be aware of the potential for severe skin reactions associated with acetaminophen. Symptoms indicative of such reactions may include skin reddening, blisters, or rash. Should any of these symptoms manifest, patients must be instructed to discontinue use immediately and seek medical assistance.

Healthcare professionals should also monitor patients for severe sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is warranted.

In the event of an overdose, immediate medical attention is critical. Patients should be advised to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help, regardless of the presence of symptoms.

Patients should be instructed to 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 5 days in children or 7 days in adults.

• Fever that worsens or persists for more than 3 days.

• Presence of redness or swelling.

• Onset of new symptoms.

• Recurrence of cough, particularly if accompanied by a rash or headache lasting beyond a few days, 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 an adult takes more than 4,000 mg of acetaminophen in 24 hours, if a child takes more than 5 doses in 24 hours, if the product is taken with other drugs containing acetaminophen, or if an adult consumes 3 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 skin reaction occurs, patients should stop use immediately and seek medical assistance.

Patients should also be cautious if they experience a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, as these symptoms warrant prompt consultation with a healthcare provider.

Common adverse reactions that may necessitate discontinuation of use and consultation with a doctor include nervousness, dizziness, or sleeplessness. Patients should also seek medical advice if pain, nasal congestion, or cough worsens or lasts longer than 5 days in children or 7 days in adults, if fever worsens or lasts more than 3 days, if redness or swelling is present, if new symptoms occur, or if a cough recurs with a rash or headache that persists. These symptoms could indicate a serious condition.

Before using this product, patients should consult a doctor if they have liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or trouble urinating due to an enlarged prostate gland. Additionally, those with a cough that occurs with excessive phlegm or a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice prior to use.

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

Drug Interactions

Patients should exercise caution when using this product in conjunction with certain medications due to potential drug interactions.

Anticoagulants Co-administration with warfarin, a blood-thinning agent, may necessitate careful monitoring. It is advisable for patients to consult with a healthcare professional prior to using this product if they are currently taking warfarin.

Monoamine Oxidase Inhibitors (MAOIs) The use of this product is contraindicated in patients currently taking prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed 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. Patients uncertain about whether their prescription includes an MAOI should seek guidance from a healthcare provider before initiating this product.

Packaging & NDC

Below are the non-prescription pack sizes of Leader Daytime Severe Cold and Flu (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive a dosage of 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a healthcare professional before administration. The use of this medication is not recommended for children under 4 years of age.

Healthcare providers should be aware of the critical nature of overdose situations. Quick medical attention is essential for both adults and pediatric patients, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 potential for altered pharmacokinetics and pharmacodynamics in this population.

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 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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if the following conditions are met:

• An adult consumes more than 4,000 mg of acetaminophen within a 24-hour period.

• A child takes more than 5 doses of the product in a 24-hour period.

• The product is taken concurrently with other medications that contain acetaminophen.

• An adult consumes 3 or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver damage, it is advisable for patients with compromised liver function to adhere strictly to the recommended dosage guidelines and to consult healthcare professionals for personalized advice regarding the use of this product. Regular monitoring of liver function may be warranted in these patients to prevent adverse effects.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of acetaminophen.

Risk of Severe Liver Damage Severe liver damage may occur in adults who exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period. For pediatric patients, the risk is similarly elevated; children are at risk of severe liver damage if they take more than five doses of acetaminophen in a 24-hour timeframe.

Additionally, the concomitant use of acetaminophen with other medications that also contain acetaminophen can lead to severe liver damage, underscoring the importance of careful medication management and patient education regarding combination therapies.

Furthermore, adults who consume three or more alcoholic drinks daily while using acetaminophen are at an increased risk for severe liver damage.

Recommended Actions Healthcare professionals should monitor patients for signs of liver injury, particularly in cases of suspected overdosage. Immediate medical attention is warranted if an overdose is suspected, and appropriate management strategies should be initiated. This may include supportive care and, in severe cases, the administration of N-acetylcysteine as an antidote to mitigate liver damage.

It is crucial for healthcare providers to educate patients on the risks associated with acetaminophen overdosage and to encourage adherence to recommended dosing guidelines to prevent potential adverse effects.

Nonclinical Toxicology

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

Postmarketing Experience

Severe skin reactions, including symptoms such as skin reddening, blisters, and rash, have been reported in association with acetaminophen use. In cases of skin reactions, it is advised to discontinue use and seek medical assistance immediately.

Additionally, it is recommended to stop use and consult a healthcare professional if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults. Other indicators for medical consultation include worsening fever lasting more than 3 days, presence of redness or swelling, emergence of new symptoms, or recurrence of cough accompanied by rash or a headache that lasts. These symptoms may signify a serious underlying condition.

Patient Counseling

Healthcare providers should advise patients about the importance of seeking immediate medical help or contacting a Poison Control Center (1-800-222-1222) in the event of an overdose. Quick medical attention is critical 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 whether a drug contains acetaminophen, 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 an MAOI within the past two weeks. Patients should be advised to check with a healthcare professional if they are unsure whether their prescription medication contains an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness.

Patients should also be advised to stop using the product and seek medical advice if their pain, nasal congestion, or cough worsens or persists beyond 5 days for children or 7 days for adults. Additionally, they should be informed to seek medical attention if a fever worsens or lasts more than 3 days, or if they notice any redness or swelling.

Healthcare providers should emphasize the importance of stopping use and consulting a doctor if new symptoms arise, or if a cough returns or occurs alongside a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients should be reminded not to exceed the recommended dosage. It is also crucial to advise 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 should be encouraged to seek medical advice if they have a cough accompanied by excessive phlegm or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

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 available for identification. It is essential to store the product at a controlled room temperature of 20-25°C (68-77°F). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling should be observed to maintain the quality and efficacy of the product throughout its shelf life.

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 essential to keep the medication out of reach of children. In the event of an overdose, patients should 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.

Drug Information (PDF)

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

View product document (PDF)