Cold and Flu

Description

LEADER™ Nighttime Cold & Flu is a liquid formulation designed for the relief of multiple cold and flu symptoms. The product contains three active ingredients: Acetaminophen, which serves as a pain reliever and fever reducer; Dextromethorphan HBr, functioning as a cough suppressant; and Doxylamine Succinate, an antihistamine.

This product is indicated for the relief of headache, fever, sore throat, minor aches and pains, sneezing, runny nose, and cough. It is suitable for individuals aged 12 years and older. The formulation is presented in a cherry flavor and is packaged in a 12 FL OZ (355 mL) bottle.

A tamper evident warning is included, stating that the product should not be used if the printed neck wrap is broken or missing. This product is comparable to Vicks® Nyquil® Cold & Flu but is not manufactured or distributed by The Procter & Gamble Company, the owner of the registered trademark.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including headache, minor aches and pains, sore throat, runny nose, sneezing, and cough due to minor throat and bronchial irritation. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Healthcare professionals are advised to instruct patients to adhere strictly to the recommended dosage guidelines. The maximum dosage should not exceed four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dose is 30 mL administered every 6 hours as needed. It is imperative that patients utilize only the dose cup provided with the medication to ensure accurate dosing.

The use of this medication is not recommended for children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use 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.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric, or emotional conditions, as well as for Parkinson’s disease. Verification of MAOI status should be conducted with a healthcare professional if there is any doubt.

• In individuals with a known history of allergic reactions to this product or any of its components, as this may lead to 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 that exceeding 4,000 mg of acetaminophen within a 24-hour period, using other medications containing acetaminophen concurrently, or consuming three or more alcoholic drinks daily while using this product significantly increases the risk of liver injury.

Acetaminophen may also provoke severe skin reactions. Symptoms such as skin reddening, blisters, or rash may indicate a serious allergic response. In the event of any skin reaction, patients should be instructed to 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 advised to consult a healthcare provider promptly.

General precautions should be taken prior to use. Patients should be encouraged to consult a physician if they have difficulty urinating due to prostate gland enlargement, liver disease, glaucoma, or any respiratory issues, including chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should seek guidance from a healthcare professional if they are currently taking blood thinners such as warfarin or sedatives and tranquilizers.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

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

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Additionally, patients may experience severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative that patients discontinue use and seek medical assistance immediately.

Marked drowsiness and excitability, particularly in children, have been reported among participants using this product. Patients are advised to avoid alcoholic beverages, as the concomitant use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Caution is recommended when driving or operating machinery due to the potential for impaired alertness.

Patients should discontinue use and consult a healthcare provider if pain or cough worsens or persists beyond 7 days, if redness or swelling occurs, if fever worsens or lasts more than 3 days, or if new symptoms arise. A return of cough accompanied by rash or headache that persists may indicate a serious condition requiring medical evaluation.

Additional considerations include the need for patients to consult a healthcare professional prior to use if they have difficulty urinating due to prostate enlargement, liver disease, glaucoma, or chronic respiratory conditions such as asthma, chronic bronchitis, or emphysema. Patients taking blood thinners such as warfarin or those on sedatives or tranquilizers should also seek advice before using this product.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription, without prior consultation with a healthcare provider. Furthermore, it is contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such treatment. Individuals with a history of allergic reactions to this product or any of its ingredients should avoid its use.

Drug Interactions

Co-administration of this medication with any other product containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease, and their interaction with this medication may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding.

Additionally, caution is advised for individuals using sedatives or tranquilizers. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, which could impair the ability to perform tasks requiring alertness. Monitoring for increased sedation is recommended in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Flu (acetaminophen, dextromethorphan hbr, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For patients aged 12 years and older, the recommended dosage is 30 mL every 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in children. It is essential to keep this medication out of reach of children. Prompt medical attention is critical for both adults and pediatric patients, even if no signs or symptoms are immediately noticeable.

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 potential adverse effects or changes in therapeutic response, given the lack of detailed information on the use of this medication in the elderly population. Individualized assessment and clinical judgment are essential when determining the appropriateness of treatment in this demographic.

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 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be advised of the potential risks associated with the use of this product, particularly due to its acetaminophen content. Severe liver damage may occur if patients exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period, especially when taken in conjunction with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product.

It is recommended that patients with known liver disease 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 without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals are advised to remain vigilant and proactive in managing potential overdose situations. The lack of immediate symptoms does not preclude the possibility of serious health consequences, and therefore, timely evaluation and treatment are essential.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the substance. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notably, severe skin reactions have been reported, which may 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. Additionally, prompt medical attention is critical for both adults and children in cases of overdose, even if no signs or symptoms are apparent.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are 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 medication contains acetaminophen, they should be encouraged to consult with 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 an MAOI within the past two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be cautioned against using this product if they have a history of allergic reactions to it or any of its ingredients. They should be instructed to discontinue use and consult a doctor if their pain or cough worsens or persists for more than seven days, if they experience redness or swelling, or if a fever worsens or lasts more than three days. Additionally, patients should be advised to seek medical attention if new symptoms arise or if a cough recurs, particularly if accompanied by a rash or headache that persists, as these may indicate a serious condition.

When using this product, patients should be made aware that marked drowsiness may occur, and excitability may be experienced, especially in children. They should be advised to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should exercise caution when driving a motor vehicle or operating machinery while using this product. It is also essential to recommend that patients consult a doctor before use if they have difficulty urinating due to an enlarged prostate gland, liver disease, glaucoma, or any breathing problems or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients should be advised to seek guidance from a doctor or pharmacist if they have a cough that produces excessive phlegm or if they are taking the blood-thinning medication warfarin, sedatives, or tranquilizers.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permitted between 15°C and 30°C (59°F and 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

No additional information is available regarding laboratory tests or postmarketing experience.

Clinicians should be aware that the medication is administered orally, with a recommended dosage of 30 mL every 6 hours for adults and children aged 12 years and older. It is contraindicated for children under 12 years. Patients who are pregnant or breastfeeding are advised to consult a healthcare professional prior to use. Additionally, resources regarding the potential for medicine abuse, particularly among teens, can be found at www.StopMedicineAbuse.org.

Drug Information (PDF)

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

View product document (PDF)