Maximum Strength Cold and Flu

Description

The product identified by SPL code 34089-3 is categorized under the 628T-Family Dollar. This designation indicates its classification within a specific family of products, although further details regarding its chemical composition, molecular weight, or dosage form are not provided in the extracted facts.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including nasal congestion, headache, cough, stuffy nose, minor aches and pains, sore throat, and sinus congestion and pressure. Additionally, it is indicated for the temporary reduction of fever. This medication also aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage guidelines. For adults and children aged 12 years and older, the prescribed dosage is 2 softgels every 4 hours, with a maximum limit of 12 softgels within a 24-hour period.

It is imperative that patients do not exceed the stated dosage to avoid the risk of overdose. 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:

• Co-administration 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.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. This includes a prohibition on use for 2 weeks following the discontinuation of an MAOI. If there is uncertainty about whether a prescription medication contains an MAOI, a healthcare professional should be consulted prior to use.

• It is also advised to adhere strictly to the recommended dosage and not exceed the directed amount when using this product.

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 recommended dosage, which is a maximum of 12 softgels within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications that contain acetaminophen or if they consume three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician without delay.

In the event of an overdose, it is imperative to seek emergency medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than seven days; fever that worsens or persists beyond three days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache lasting for an extended period. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 12 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.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts longer than seven days, or if fever worsens or persists beyond three days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting longer than expected may indicate a serious condition, warranting immediate medical evaluation.

Drug Interactions

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

The use of this product 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 used for a period of two weeks following the discontinuation of an MAOI to avoid serious interactions.

Caution is advised when this product is used in conjunction with warfarin, a blood-thinning medication. The combination may elevate the risk of bleeding; therefore, close monitoring of coagulation parameters is recommended in patients receiving both therapies. Adjustments to the dosage of warfarin may be necessary based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Maximum Strength 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 not use this medication. For adolescents aged 12 years and older, the recommended dosage is 2 softgels every 4 hours.

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 adverse effects or changes in therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics 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

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 12 softgels within a 24-hour period. Additionally, patients are advised against the concurrent use of other medications containing acetaminophen, as this may further increase the risk of liver injury.

It is also important for patients with compromised liver function to limit alcohol consumption. Specifically, the intake of three or more alcoholic drinks daily while using this product is contraindicated, as it may exacerbate the potential for liver damage. Monitoring of liver function is recommended for patients with hepatic impairment who are prescribed this product, to ensure safety and mitigate the risk of adverse effects.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product.

Risk of Severe Liver Damage Taking more than 12 softgels within a 24-hour period, which is the maximum recommended daily dosage, can lead to severe liver damage. Healthcare professionals should be vigilant in assessing patients who may have exceeded this limit.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a further risk of severe liver damage. It is crucial for healthcare providers to inquire about all medications a patient is taking to prevent potential interactions that could exacerbate liver toxicity.

Alcohol Consumption Patients who consume three or more alcoholic drinks daily while using this product are also at an increased risk of severe liver damage. Healthcare professionals should advise patients on the dangers of combining alcohol with this medication and monitor for signs of liver impairment.

In the event of suspected overdosage, immediate medical attention is warranted. Healthcare providers should initiate appropriate management procedures, which may include supportive care and monitoring of liver function tests, to mitigate the risk of serious complications.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified reports of severe skin reactions associated with acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, users are advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients about the risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be cautioned against using this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification.

Healthcare providers should instruct patients not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients should be advised to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. New symptoms that arise should also prompt a consultation with a healthcare provider.

Patients should be informed that if a cough returns or occurs alongside a rash or persistent headache, they should seek medical attention, as these may indicate a serious condition. It is essential to remind patients to adhere strictly to the directed dosage and not exceed it.

Before using this product, patients should be encouraged to consult their healthcare provider if they have any of the following conditions: liver disease, heart disease, diabetes, high blood pressure, thyroid disease, or difficulty urinating due to an enlarged prostate gland. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Furthermore, patients experiencing a cough accompanied by excessive phlegm should consult a healthcare provider. Lastly, patients taking the blood-thinning medication warfarin should discuss their use of this product with their doctor or pharmacist.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat to maintain product integrity. Proper storage conditions are essential to ensure the efficacy and safety of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)