Cold and Flu

Description

meijer® Cold & Flu Severe is a combination medication formulated to provide relief from multiple symptoms associated with cold and flu. The active ingredients include Acetaminophen, Dextromethorphan HBr, Guaifenesin, and Phenylephrine HCl, which collectively function as a pain reliever, fever reducer, cough suppressant, expectorant, and nasal decongestant.

This product is designed to alleviate symptoms such as headache, fever, sore throat, nasal congestion, cough, mucus, and chest congestion. It is available in the form of caplets, with a total count of 24 caplets per package.

The product is packaged with a tamper evident warning, indicating that it should not be used if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. meijer® Cold & Flu Severe is distributed by Meijer Distribution, Inc., located in Grand Rapids, MI 49544, and is not manufactured or distributed by Kenvue Inc., the owner of the registered trademark Tylenol® COLD + FLU SEVERE. For more information, visit www.meijer.com.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including sore throat, cough, nasal congestion, headache, and minor aches and pains. It also aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby making coughs more productive. Additionally, this drug temporarily reduces fever.

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 caplets every 4 hours as needed. The caplets should be swallowed whole; they must not be crushed, chewed, or dissolved. It is imperative that no more than 10 caplets are taken within a 24-hour period.

For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

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) for depression, psychiatric, or emotional conditions, or Parkinson’s disease, and for a period of 2 weeks following the discontinuation of the MAOI. This is due to the potential for serious interactions. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is imperative to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms arise, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning 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.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: heart disease, liver disease, diabetes, a cough associated with excessive phlegm, persistent or chronic cough (such as that seen in smoking, asthma, chronic bronchitis, or emphysema), thyroid disease, high blood pressure, or difficulty urinating due to prostate enlargement. Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare provider or pharmacist before using this product.

Emergency Medical Help 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 right away, regardless of whether symptoms are present.

Discontinuation of Use Patients should be advised to stop taking this product and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if new symptoms develop; if fever worsens or lasts more than three days; if redness or swelling occurs; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur with the use of acetaminophen, particularly if patients exceed 4,000 mg in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is recommended that they consult a healthcare professional promptly.

Participants should stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Furthermore, if pain, nasal congestion, or cough worsens or lasts longer than seven days, or if new symptoms arise, medical consultation is warranted. Patients should also be vigilant if fever worsens or persists for more than three days, if redness or swelling is observed, or if a cough recurs or occurs alongside a rash or headache lasting for an extended period, as these may indicate a serious condition.

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), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be administered within two weeks of discontinuing an MAOI, as this may lead to serious adverse effects.

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 interactions that could affect bleeding risk.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period.

Geriatric Use

There is no specific information available 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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended 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 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 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concurrent use with other medications that contain acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks per day while using this product is strongly discouraged, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

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 should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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 associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed not to exceed the recommended dosage of the medication. They should also be informed to discontinue use and consult a doctor if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 7 days; the emergence of new symptoms; a fever that worsens or persists for more than 3 days; any redness or swelling; or if a cough recurs or is accompanied by a rash or headache that lasts, as these may indicate a serious condition.

It is important for patients to consult with a healthcare provider before using the medication if they have any of the following conditions: heart disease, liver disease, diabetes, a cough associated with excessive phlegm, a persistent or chronic cough (such as that which occurs with smoking, asthma, chronic bronchitis, or emphysema), thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland.

Additionally, patients should be advised to speak with a doctor or pharmacist prior to use if they are currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a tamper-evident package. It should not be used if the outer package is opened or if the blister is torn or broken. The recommended storage temperature is 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). Healthcare professionals are advised to check the end flap for the expiration date and lot number to ensure product integrity and safety.

Additional Clinical Information

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

Clinicians should be aware of the potential for medicine abuse, particularly among adolescents, and can refer to www.StopMedicineAbuse.org for further information. The recommended route of administration is oral. For adults and children aged 12 years and older, the dosage is 2 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period. For children under 12 years, it is advised to consult a doctor. Additionally, patients who are pregnant or breastfeeding should seek guidance from a health professional before use.

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)