Maximum Strength Daytime Non Drowsy Severe Cold and Flu

Description

This formulation is a maximum strength daytime non-drowsy severe cold and flu medication, designed to provide relief from multiple symptoms. Each softgel contains 325 mg of acetaminophen, serving as a pain reliever and fever reducer; 10 mg of dextromethorphan HBr, acting as a cough suppressant; 200 mg of guaifenesin, functioning as an expectorant; and 5 mg of phenylephrine HCl, which serves as a nasal decongestant. The product is indicated for the relief of headache, fever, sore throat, minor aches and pains, cough, chest congestion, nasal and sinus congestion, and sinus pressure. The medication is supplied in a package containing 10 softgels.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza, including minor aches and pains, headache, sore throat, nasal congestion, and cough. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby enhancing the productivity of coughs. The drug also temporarily reduces fever.

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

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 and must not be crushed, chewed, or dissolved to ensure proper release and absorption of the medication. It is important to note that the total dosage should not exceed 10 caplets within a 24-hour period.

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

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.

• Concurrent use with a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions.

• History of allergic reaction to this product or any of its ingredients, which may result in severe hypersensitivity reactions.

Healthcare professionals should ensure that patients are aware of these contraindications prior to prescribing or recommending this product.

Warnings and Precautions

This product contains acetaminophen, which necessitates careful monitoring due to the potential for severe liver damage. The maximum recommended daily dosage is 10 caplets, equating to 3,250 mg of acetaminophen within a 24-hour period. Healthcare professionals should advise patients against exceeding 4,000 mg of acetaminophen in a single day, using other medications that also contain acetaminophen concurrently, or consuming three or more alcoholic beverages daily while taking this product.

Acetaminophen may also provoke severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

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

Patients should be advised to stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if fever intensifies or lasts more than three days, medical consultation is warranted. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting longer than usual may indicate a serious condition requiring prompt evaluation.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 without delay, as timely intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can be categorized by seriousness and frequency.

Severe adverse reactions include significant liver damage, which may occur if the maximum daily dose of acetaminophen exceeds 4,000 mg, if the product is taken in conjunction with other medications containing acetaminophen, or if the patient consumes three or more alcoholic drinks daily while using this product. Patients should be vigilant for symptoms of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of such a reaction, it is imperative to discontinue use and seek medical assistance immediately.

Common adverse reactions that warrant discontinuation of use and consultation with a healthcare provider include nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if fever intensifies or lasts more than three days, medical advice should be sought. Patients should also be alert for signs of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache, as these may indicate a serious condition.

Before using this product, patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland should consult a healthcare professional. Furthermore, individuals with a persistent or chronic cough, particularly those associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Patients taking the anticoagulant warfarin should consult a doctor or pharmacist before using this product to avoid potential interactions.

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, 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 used for at least two weeks following the discontinuation of an MAOI, as this may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safe use and to mitigate the risk of potential interactions that could affect bleeding risk.

Packaging & NDC

Below are the non-prescription pack sizes of Maximum Strength Daytime Non Drowsy Severe Cold and Flu (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). 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

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the variability in pharmacokinetics and pharmacodynamics that can occur with aging.

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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. The maximum daily dose is limited to 10 caplets (3,250 mg of acetaminophen) within a 24-hour period. It is critical to note that severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients with liver disease are advised to consult a healthcare professional prior to use to assess the appropriateness of this product and to discuss potential risks associated with acetaminophen. Regular monitoring of liver function may be warranted in these patients to prevent adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is essential 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, vigilance and timely action are crucial in managing overdose situations effectively.

Nonclinical Toxicology

No teratogenic effects have been reported in the available data. Additionally, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any specific details. Furthermore, there is no information available concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may manifest 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 be sought.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to 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 signs or symptoms are apparent.

Patients should be cautioned against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a medication contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is important to inform patients that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be advised to check with their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be instructed not to use it. They should also be informed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

Additionally, patients should be advised to stop using the product and seek medical advice if their pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if they notice any redness or swelling. They should also be instructed to seek medical attention if new symptoms arise or if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition.

Patients must be reminded not to exceed the recommended dosage while using this product. Furthermore, they should be encouraged to consult a doctor before use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, or if they have a cough that produces excessive phlegm. Lastly, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist before using this product.

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 25ºC (77ºF). Temporary excursions from this temperature are permissible, provided they remain within the range of 15ºC to 30ºC (59ºF to 86ºF). Proper container requirements must be adhered to, ensuring that the product is protected from excessive heat and moisture. Special handling considerations should be observed to maintain the integrity of the product throughout its storage period.

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 crucial 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 at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)