Non-Drowsy Daytime Cold and Flu Max Softgels Maximum Strength

Description

TopCare health offers a non-drowsy daytime cold and flu relief formulation, available in a maximum strength softgel dosage form. The product is comparable to Alka-Seltzer® Plus® Maximum Strength Daytime Cold & Flu PowerMax™ Gels and is identified by NDC 36800-720-24. Each liquid-filled capsule contains the following active ingredients: acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and phenylephrine HCl, a nasal decongestant. This formulation is designed to relieve symptoms associated with nasal congestion, cough, headache and body ache, sore throat, and sinus pressure. The product is packaged in a count of 24 softgels, featuring a smaller capsule size while maintaining the same strength as the original formulation.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or influenza. Specifically, it alleviates minor aches and pains, headache, cough, sore throat, and nasal and sinus congestion. Additionally, it temporarily reduces fever.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 softgels with water every 4 hours as needed. The maximum dosage should not exceed 10 softgels within a 24-hour period, unless otherwise directed by a healthcare professional.

This medication is not recommended for use in children under 12 years of age.

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.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as this may lead to serious drug interactions.

• In individuals with a history of allergic reactions to this product or any of its ingredients, to prevent potential anaphylactic reactions.

• In children under 12 years of age, due to safety concerns and lack of efficacy data in this population.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin or allergic reactions. Symptoms indicative of such reactions include skin reddening, blisters, rash or hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, it is imperative to 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, prompt consultation with a healthcare provider is advised.

It is crucial to avoid the concurrent use of this product with any other medications containing acetaminophen, whether prescription or nonprescription. Healthcare professionals should be consulted if there is uncertainty regarding the presence of acetaminophen in other medications. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. If there is any doubt regarding the presence of an MAOI in a prescription, a healthcare provider should be consulted prior to use.

Individuals with a history of allergic reactions to this product or any of its components should refrain from its use. Furthermore, this product is not recommended for children under 12 years of age.

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

Patients should discontinue use and consult a healthcare provider if any of the following occur: worsening pain, cough, or nasal congestion lasting more than seven days; fever worsening or persisting beyond three days; presence of redness or swelling; emergence of new symptoms; recurrence of cough accompanied by rash or headache lasting; or the onset of nervousness, dizziness, or sleeplessness. Pregnant or breastfeeding individuals should seek advice from a healthcare professional before using this product.

Side Effects

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

Patients should be aware of the potential for severe skin or allergic reactions associated with acetaminophen. Symptoms of such reactions may include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients are advised to stop use and consult a healthcare professional if pain, cough, or nasal congestion 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 or occurs alongside a rash or headache that lasts. These symptoms may indicate a serious condition. Additionally, if patients experience nervousness, dizziness, or sleeplessness, they should seek medical advice.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a doctor promptly. In the event of an overdose, it is crucial to obtain medical help or contact a Poison Control Center immediately, as timely 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), which includes certain medications prescribed for depression, psychiatric disorders, 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 Non-Drowsy Daytime Cold and Flu Max Softgels Maximum Strength (acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride). 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 taken with water every 4 hours, with a maximum of 10 softgels in a 24-hour period, unless otherwise directed by a healthcare professional. Caution is advised to ensure adherence to the specified dosage limits.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including 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 potential adverse effects or changes in efficacy, given the lack of targeted data for 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 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. It is important to note that severe liver damage may occur if patients exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period, take other medications that also contain acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product. It is crucial for patients to adhere strictly to the recommended dosage and to avoid exceeding it, as doing so may significantly increase the risk of liver injury. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy while using this product.

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 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 comprehensive 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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include severe skin reactions such as skin reddening, blisters, rash, hives, and facial swelling. Additionally, allergic reactions have been noted, which encompass symptoms like asthma (wheezing) and shock. Reports of nervousness, dizziness, and sleeplessness have also been documented.

Patient Counseling

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

Patients who are pregnant or breastfeeding should be encouraged to consult with a healthcare professional prior to using this product. This discussion is important to ensure the safety of both the patient and the child.

Additionally, healthcare providers should instruct patients to adhere strictly to the recommended dosage and to avoid exceeding it while using this product. This guidance is essential to minimize the risk of adverse effects and ensure safe usage.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that temperatures do not exceed 25°C (77°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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