Meijer Daytime Cold and Flu Softgel

Description

Daytime Cold and Flu is a pharmaceutical formulation designed to alleviate symptoms associated with cold and flu conditions. It is specifically formulated for daytime use, providing relief without causing drowsiness. The product contains a combination of active ingredients that target common symptoms such as nasal congestion, cough, and fever. The formulation is available in a convenient dosage form, ensuring ease of administration.

Uses and Indications

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

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 4 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

There are no specific contraindications listed for this product. However, in the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt medical attention is crucial for both adults and children, regardless of the presence of signs or symptoms.

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 also warranted when this product is taken in conjunction with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily.

Acetaminophen has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. Should any skin reaction occur, patients must 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 instructed to consult a physician without delay.

This product should not be used concurrently with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be advised 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.

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, diabetes, high blood pressure, thyroid disease, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm or chronic conditions such as smoking, asthma, or emphysema. Furthermore, patients taking the anticoagulant warfarin should seek advice from a healthcare provider or pharmacist prior to use.

Patients must be cautioned against exceeding the directed dosage when using this product.

If patients experience symptoms such as nervousness, dizziness, or sleeplessness, or if pain, nasal congestion, or cough worsens or persists beyond seven days, they should be advised to stop use and consult a physician. Additionally, if fever worsens or lasts more than three days, or if redness or swelling occurs, medical advice should be sought. New symptoms or a recurrence of cough, particularly if accompanied by a rash or headache that lasts, may indicate a serious condition, warranting immediate medical evaluation.

In the event of an overdose, patients must seek emergency medical assistance or contact a Poison Control Center immediately. Prompt medical attention is crucial 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.

In cases of severe sore throat that 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.

Patients should also discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs with a rash or headache that persists. These symptoms may indicate a serious underlying condition.

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

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

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

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to avoid potential alterations in anticoagulant effect.

Packaging & NDC

Below are the non-prescription pack sizes of Meijer Daytime Cold and Flu Softgel (acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride). 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 adolescents and adults aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, with a maximum of 8 softgels in a 24-hour period.

Geriatric Use

There is no specific information regarding the use of Meijer Daytime Cold and Flu Softgel in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the lack of data and the potential for increased sensitivity to medications in this population. Monitoring for efficacy and adverse effects is recommended when administering this product to elderly individuals.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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 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. The maximum recommended dosage is 8 softgels in a 24-hour period. Exceeding this dosage, using other medications that contain acetaminophen concurrently, or consuming 3 or more alcoholic drinks daily while using this product may significantly increase the risk of liver injury.

It is advised that patients with known liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks. Monitoring of liver function may be warranted in these patients to ensure safety and to mitigate the risk of adverse effects.

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 early intervention may significantly influence the outcome.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this 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 cases of accidental overdose.

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.

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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)