Cold and Flu Severe

Description

NDC 3600-502-05. Topcare® Health Cold + Flu Severe is a combination medication formulated for the relief of symptoms associated with severe cold and flu. Each dosage form contains Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, and Guaifenesin, serving as a pain reliever/fever reducer, cough suppressant, nasal decongestant, and expectorant. This product is indicated for the relief of head and body aches, fever, sore throat, cough, nasal congestion, and mucus and chest congestion. It is intended for adult use and is available in a package containing 24 cool taste caplets.

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; they must not be crushed, chewed, or dissolved to ensure proper absorption and efficacy. It is important to note that the maximum dosage should not exceed 10 caplets 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 uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• 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. If there is uncertainty regarding the presence of an MAOI in a prescription medication, a healthcare professional should be consulted.

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

Warnings and Precautions

This product contains acetaminophen, and it is crucial to adhere to the maximum daily dose of 10 caplets (3,250 mg acetaminophen) within a 24-hour period. Severe liver damage may occur if the following conditions are met: exceeding 4,000 mg of acetaminophen in 24 hours, using other medications that contain acetaminophen concurrently, or consuming three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance. Additionally, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Healthcare professionals should advise patients to consult a doctor prior to 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 a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients should be cautioned to seek guidance from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin. It is essential that patients do not exceed the recommended dosage while using this product.

In cases of overdose, immediate medical attention is necessary. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) without delay, as rapid 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 they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 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 or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

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

Patients may experience severe skin reactions associated with acetaminophen, which can 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 should consult a healthcare professional promptly.

Patients are advised against using this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Additionally, it should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Those with a known allergy to this product or any of its ingredients should also refrain from use.

Before using this product, patients should consult a doctor if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Individuals with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

While using this product, patients must adhere to the recommended dosage and should discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists for more than seven days, or if fever worsens or lasts more than three days, medical advice should be sought. Patients should also seek medical attention if redness or swelling occurs, new symptoms develop, or if a cough recurs with a rash or headache that lasts.

In the event of an overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, 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 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 disorders, or Parkinson's disease. Additionally, it should not be used for at least 2 weeks following the discontinuation of an MAOI to avoid potential hypertensive crises or other 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 mitigate the risk of increased bleeding.

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Flu Severe (acetaminophen, dextromethorphan hydrobromide, guaifenesin, and 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 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 the safety of both the mother and the developing fetus.

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 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. 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 based on their specific liver function status. Monitoring of liver function may be warranted in these patients to prevent potential adverse effects associated with acetaminophen use.

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 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, vigilance and timely action are essential in managing overdose situations effectively.

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

Postmarketing experience has identified reports of severe skin reactions associated with acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Patients should be advised to keep this product out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. MAOIs are often prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If patients are unsure whether their prescription includes an MAOI, they should seek guidance from a healthcare professional.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised not to use it. They should also be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be informed to stop using the product and 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 or a recurrence of cough, especially if accompanied by a rash or persistent headache, should prompt patients to contact their healthcare provider, as these may indicate a serious condition.

Patients must be reminded not to exceed the recommended dosage while using this product. It is essential for patients to consult a doctor before use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, 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 before using this product. Furthermore, patients who have a cough accompanied by excessive phlegm should consult a healthcare professional prior to use. Lastly, patients taking the blood-thinning medication warfarin should be advised to discuss their use of this product with a doctor or pharmacist.

Storage and Handling

The product is supplied in a carton that should be retained for complete product information. It is essential to store the product in a dry place at a temperature range of 20-25°C (68-77°F) to ensure its stability and efficacy. Proper storage conditions are critical for maintaining the integrity of the product.

Additional Clinical Information

The medication is administered orally. For adults and children 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. Patients should swallow the caplets whole and are advised not to crush, chew, or dissolve them. For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

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