Meijer Nighttime Cold and Flu Softgel

Description

Nighttime Cold & Flu is a pharmaceutical formulation designed to alleviate symptoms associated with cold and flu during nighttime. It is specifically engineered to provide relief from discomfort, allowing for improved sleep quality. The product contains a combination of active ingredients that target common symptoms such as cough, congestion, and fever. The formulation is available in a liquid dosage form, facilitating ease of administration. The appearance of the product is a clear to slightly opalescent solution, typically presented in a dark-colored bottle to protect the contents from light.

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

The medication should be taken only as directed. For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 6 hours, not to exceed 8 softgels within a 24-hour period.

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

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is essential. Quick medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 8 softgels within a 24-hour period, concurrent use with other acetaminophen-containing medications, or consumption of three or more alcoholic drinks daily while using this product.

Severe skin reactions may occur due to acetaminophen, with symptoms including skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Contraindications and Precautions

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should be directed to consult a healthcare professional. Additionally, this product is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. Patients should be encouraged to verify with their healthcare provider or pharmacist if they are unsure about their prescription drugs.

Patients should be advised to seek medical guidance before using this product if they have any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, glaucoma, a cough associated with excessive phlegm, or any breathing problems such as chronic cough, asthma, chronic bronchitis, or emphysema. Furthermore, individuals experiencing difficulty urinating due to an enlarged prostate gland should also consult a healthcare professional prior to use.

Drug Interactions and Usage Guidelines

Patients taking sedatives, tranquilizers, or the anticoagulant warfarin should consult a doctor or pharmacist before using this product. When using this medication, it is crucial to adhere strictly to the recommended dosage. Notably, excitability may occur, particularly in children, and marked drowsiness may be experienced. Patients should be cautioned against consuming alcoholic beverages and should exercise caution when driving or operating machinery, as alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Emergency Situations

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

Monitoring and Follow-Up

Patients should discontinue use and contact their healthcare provider 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 underlying condition requiring further evaluation.

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.

Additional adverse reactions that may occur during the use of this product include excitability, particularly in children, and marked drowsiness. Patients are cautioned to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Care should be taken when driving a motor vehicle or operating machinery.

Patients should discontinue use and consult a doctor if pain or cough worsens or lasts longer than seven days, if fever worsens or persists for more than three days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs or occurs alongside a rash or headache that lasts. These symptoms could indicate a serious condition requiring medical evaluation.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson’s disease, as well as for a period of 2 weeks following the discontinuation of an MAOI. This combination may lead to serious and potentially life-threatening interactions.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as these substances may enhance the sedative effects of the medication, leading to increased drowsiness.

Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider before using this medication, as there may be an increased risk of bleeding or other adverse effects.

Caution is advised when consuming alcohol, as it may further increase drowsiness when taken in conjunction with this medication, along with other sedatives and tranquilizers. Monitoring for excessive sedation and other related effects is recommended in such cases.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 4 years of age should not use this medication. For children aged 4 to under 12 years, it is advised to consult a healthcare professional before use.

For adolescents and adults aged 12 years and older, the recommended dosage is 2 softgels taken with water every 6 hours, with a maximum of 8 softgels in a 24-hour period.

Healthcare professionals should be aware that excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients.

Geriatric Use

There is no specific information 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy 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 the safety of both the mother and the developing fetus.

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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 8 softgels within a 24-hour period. Additionally, patients should avoid concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than 3 drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

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 essential for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are crucial in managing overdose situations effectively.

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notably, severe skin reactions have been reported, which 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.

Patient Counseling

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

In the event of an overdose, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. They should stress that quick medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can significantly enhance patient safety and outcomes.

Storage and Handling

The product is supplied in packaging that ensures its integrity and stability. It should be stored at a controlled room temperature 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. Proper storage conditions are essential for preserving the quality 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 health professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients must seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)