Leader Nighttime Cold and Flu

Description

Acetaminophen and Dextromethorphan HBr are the active ingredients in this formulation, which serves as a pain reliever, fever reducer, cough suppressant, and antihistamine. The product is presented in a liquid dosage form with a cherry flavor, enhancing palatability. It contains 10% alcohol and is packaged in an 8 fluid ounce (237 mL) container.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, fever, as well as runny nose and sneezing.

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. 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 30 mL every 6 hours as needed.

For children aged 4 to under 12 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 remind patients of the importance of not exceeding the recommended dosage to avoid potential 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, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, using other medications that contain acetaminophen concurrently, or consuming three or more alcoholic drinks daily while using this product.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance. Additionally, if a patient experiences a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a physician promptly.

General precautions should be taken for patients with specific medical conditions. Prior to use, patients should be advised to consult a healthcare provider if they have liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough related to smoking, asthma, or emphysema, or if they are on a sodium-restricted diet. Furthermore, patients should seek guidance from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, even if no signs or symptoms are apparent.

Patients should discontinue use and consult a healthcare professional if pain or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs alongside a rash or headache that lasts. These symptoms may indicate a serious condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using the product. Patients should be aware of the potential for severe skin reactions, 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.

Participants may experience excitability, particularly in children, as well as marked drowsiness. Caution is advised when driving or operating machinery, and the consumption of alcoholic drinks should be avoided, as alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Patients are advised to stop use and consult a healthcare provider if pain or cough worsens or persists beyond 7 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs with a rash or headache that lasts, as these may indicate a serious condition.

Before using this product, patients should consult a doctor if they have liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough related to smoking, asthma, or emphysema, or if they are on a sodium-restricted diet. Additionally, patients should seek advice from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the potential for acetaminophen overdose and associated hepatotoxicity.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson’s disease should consult a healthcare professional prior to use. This includes individuals who have discontinued MAOI therapy within the past two weeks, as significant interactions may occur.

Caution is advised when this medication is used concurrently with warfarin, a blood-thinning agent, as it may elevate the risk of bleeding. Monitoring of coagulation parameters is recommended to ensure patient safety and to adjust warfarin dosage if necessary.

No specific laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Leader Nighttime Cold and Flu (acetaminophen, dextromethorphan hbr, doxylamine succinate). 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. Caution is advised as excitability may occur, particularly in pediatric patients.

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. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 be advised of the potential risks associated with the use of this product, which contains acetaminophen. Severe liver damage may occur if the total daily dosage of acetaminophen exceeds 4,000 mg. Additionally, patients should be cautioned against the concurrent use of other medications containing acetaminophen, as this may further increase the risk of liver damage.

It is also important for patients to be aware that the consumption of three or more alcoholic drinks per day while using this product may significantly heighten the risk of severe liver damage.

Patients with known liver disease are strongly encouraged to consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss any necessary dosage adjustments or monitoring requirements.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

Nonclinical Toxicology

No teratogenic effects have been observed in nonclinical studies. Additionally, there are no reported non-teratogenic effects. The available data do not provide any details regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse events associated with the use of acetaminophen, reported voluntarily or through surveillance programs.

Severe skin reactions, including symptoms such as skin reddening, blisters, and rash, have been noted. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, excitability has been reported, particularly in pediatric populations. Marked drowsiness is another noted effect, which may be exacerbated by the concurrent use of alcohol, sedatives, or tranquilizers.

Reports indicate that if pain or cough worsens or persists beyond 7 days, or if fever intensifies or lasts more than 3 days, medical evaluation should be sought. The presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting for an extended period may indicate a serious underlying condition requiring prompt medical attention.

Patient Counseling

Healthcare providers should advise patients about the importance of seeking immediate medical attention in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222, as prompt medical intervention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients must be cautioned against using this product in conjunction with any other medications that contain 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 inform patients that this product should not be used 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 verify with their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be instructed not to use it. Additionally, they should be advised to discontinue use and consult a doctor if their pain or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, or if new symptoms develop. Patients should also be informed to seek medical advice if a cough recurs or is accompanied by a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. They should be cautioned to avoid alcoholic beverages while using this product, as well as to exercise caution when driving or operating machinery. Patients should also be informed that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Healthcare providers should recommend that patients consult a doctor before using this product if they have liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough related to smoking, asthma, or emphysema, or if they are on a sodium-restricted diet. Furthermore, patients should be advised to seek guidance from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

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 temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures, which may compromise the product's quality.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. Patients are advised to avoid alcoholic beverages and to exercise caution when driving or operating machinery due to potential effects of the medication.

Drug Information (PDF)

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

View product document (PDF)