Meijer Nighttime Cold and Flu Softgel

Description

Nighttime Cold and Flu SOFTGEL is a dosage form designed to alleviate symptoms associated with cold and flu during nighttime. The formulation is specifically engineered to provide relief while promoting restful sleep. The softgel presentation allows for easy ingestion and rapid dissolution in the gastrointestinal tract, facilitating the absorption of active ingredients.

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 take the medication only as directed. The recommended dosage for adults and children aged 12 years and older 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 recommendations. The use of this medication is not recommended for children under 4 years of age.

Contraindications

There are no specific contraindications listed for 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 to adhere strictly to the maximum daily dosage of 8 softgels within a 24-hour period. Caution is warranted when this product is taken in conjunction with other medications containing acetaminophen, as well as when consuming three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, patients should discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days, or if accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a physician promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a healthcare professional. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Patients should be encouraged to verify with their healthcare provider or pharmacist if they are unsure about the presence of an MAOI in their prescription.

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, thyroid disease, diabetes, glaucoma, a cough that produces excessive phlegm, or a history of breathing problems such as asthma, chronic bronchitis, or emphysema. Patients experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use.

Patients should be advised to consult a doctor or pharmacist before using this product if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

While using this product, patients must not exceed the recommended dosage. Excitability may occur, particularly in children, and marked drowsiness is a potential side effect. Patients should be cautioned to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery, given that alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Patients should discontinue use and seek medical advice if pain or cough worsens or persists beyond 7 days, if fever worsens 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. These symptoms may indicate a serious condition.

For individuals who are pregnant or breastfeeding, consultation with a healthcare professional is recommended prior to use.

In the event of an overdose, immediate medical attention should be sought, or contact with a Poison Control Center is advised. Prompt medical intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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.

Participants should also be cautioned regarding the risk of excitability, particularly in children, and marked drowsiness, which may occur during the use of this product. It is advisable to avoid alcoholic beverages, as well as sedatives and tranquilizers, as these may exacerbate drowsiness. Patients should exercise caution when driving or operating machinery.

In clinical observations, patients are advised to stop use and consult a healthcare provider if pain or cough worsens or persists beyond 7 days, if fever worsens or lasts more than 3 days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs with a rash or headache that lasts. These symptoms could indicate a serious underlying condition.

In cases of overdose, it is critical for patients to seek immediate medical attention or contact a Poison Control Center, as prompt medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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), which includes certain medications for depression, psychiatric conditions, or Parkinson's disease. Additionally, it should not be administered for at least 2 weeks following the discontinuation of an MAOI.

Caution is advised when considering the use of this medication in conjunction with sedatives or tranquilizers. Patients should consult a healthcare professional prior to use to evaluate potential interactions and the need for dosage adjustments.

Furthermore, individuals taking the anticoagulant warfarin should seek guidance from a healthcare provider before using this medication, as interactions may affect anticoagulation control.

It is important to note that the concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, necessitating careful monitoring of patients for increased sedation and impairment.

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 aged 4 to under 12 years should consult a healthcare professional before use. The product is contraindicated in children under 4 years of age. For dosing, adults and children aged 12 years and older may take 2 softgels with water every 6 hours, with a maximum of 8 softgels in a 24-hour period.

Caution is advised as excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

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

Healthcare professionals are advised to remain vigilant and proactive in managing potential overdose situations. The importance of rapid response cannot be overstated, as timely treatment may significantly influence patient 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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: severe skin reactions, which include skin reddening, blisters, and rash.

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 households 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 impact the outcome in overdose situations.

Storage and Handling

The product is supplied in packaging that ensures its integrity and stability. It should be stored at room temperature, specifically within the range of 20° to 25°C (68° to 77°F). It is essential to protect the product from light, heat, and moisture to maintain its efficacy and safety. Proper handling and storage conditions are crucial 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 should seek immediate medical assistance or contact a Poison Control Center, as prompt 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)