Cvs Severe Multi-Symptom Cough Cold Flu

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or influenza. Specifically, it addresses the following symptoms: cough due to minor throat and bronchial irritation, nasal congestion, sinus congestion and pressure, minor aches and pains, sore throat, headache, and fever. Additionally, this drug aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes and enhancing the productivity of coughs.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 20 milliliters (ml) administered every 4 hours as needed. It is imperative that no more than 6 doses are taken within a 24-hour period. Healthcare professionals should advise patients to adhere strictly to the recommended dosage, as exceeding this may result in serious liver damage.

For accurate dosing, it is essential to use the dosing cup provided with the product. Patients should be instructed to keep the dosing cup with the product to ensure proper measurement. This product is not intended for use in children under 12 years of age, and healthcare providers should refrain from recommending it for this age group.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson's disease, should not use this product. Additionally, use is contraindicated for 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

This product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is any doubt about the presence of acetaminophen in a medication, a healthcare professional should be consulted.

Furthermore, it is essential to adhere to the recommended dosage and not exceed the directed use of this product.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 6 doses within a 24-hour period (the maximum daily amount), concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any skin reaction occur, it is imperative to discontinue use immediately and seek medical assistance.

Consultation Prior to Use Healthcare professionals should advise patients to consult a physician before using this product 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 cough associated with excessive phlegm. Additionally, individuals with breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should also seek medical advice prior to use.

Patients should be cautioned to consult a doctor or pharmacist before using this product if they are currently taking the anticoagulant warfarin, any other oral nasal decongestants or stimulants, or any other pain relievers or fever reducers.

Emergency Medical Assistance In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent. Prompt intervention is essential for both adults and children.

Discontinuation of Use Patients should stop using this product and consult a healthcare provider if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening pain, cough, or nasal congestion lasting more than 7 days; fever that worsens or persists beyond 3 days; presence of redness or swelling; emergence of new symptoms; or a cough that recurs or is accompanied by a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of six doses 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 patients experience a severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

Patients are advised to stop use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness; if pain, cough, or nasal congestion worsens or lasts longer than seven days; if fever worsens or persists for more than three 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 requiring medical evaluation.

Drug Interactions

Co-administration of acetaminophen and warfarin may elevate the risk of bleeding. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients receiving this combination to ensure safe therapeutic levels.

Additionally, the use of this product in conjunction with other medications containing acetaminophen is contraindicated. This combination may lead to an overdose of acetaminophen, which poses a significant risk of liver damage. Therefore, careful consideration should be given to the total daily intake of acetaminophen from all sources to prevent potential toxicity.

Packaging & NDC

Below are the non-prescription pack sizes of Cvs Severe Multi-Symptom Cough Cold Flu (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. For patients aged 12 years and older, the recommended dosage is 20 ml every 4 hours. There are no established safety or efficacy profiles for children under 12 years, and therefore, use in this population is contraindicated.

Geriatric Use

Elderly patients may have an increased risk of adverse effects when using this product, particularly those aged 65 and older. It is essential for healthcare providers to exercise caution and consider potential dose adjustments based on individual health status and concurrent medications.

Before initiating treatment, it is advisable for elderly patients to consult with a healthcare professional if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland. Additionally, those with respiratory conditions such as chronic cough, asthma, chronic bronchitis, or emphysema should seek medical advice prior to use.

Elderly patients taking anticoagulants, such as warfarin, or other oral nasal decongestants or stimulants should also consult a healthcare provider or pharmacist to avoid potential drug interactions.

While using this product, elderly patients should adhere strictly to the recommended dosage and avoid exceeding the directed amount. They should be monitored for any adverse reactions, and if symptoms such as nervousness, dizziness, sleeplessness, worsening pain, cough, or nasal congestion occur or persist beyond the specified duration, it is crucial to discontinue use and seek medical attention. Signs such as fever worsening or lasting more than three days, the presence of redness or swelling, the emergence of new symptoms, or a cough that recurs with a rash or persistent headache may indicate a serious condition requiring prompt evaluation.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with its 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

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the insert. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance 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 amount of 6 doses within any 24-hour period. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if patients consume 3 or more alcoholic drinks daily while using this product.

It is recommended that patients with known liver disease consult a healthcare professional prior to use to assess the appropriateness of this medication and to discuss potential risks. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

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 crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, it is essential to monitor the patient closely and provide appropriate medical 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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

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 critical for both adults and children, even if no signs or symptoms are present.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the last two weeks. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist.

It is important to inform patients not to use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. Patients should be advised to verify the contents of their medications with a healthcare professional if they are unsure.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if pain, cough, or nasal congestion worsens or persists beyond 7 days, if fever worsens or lasts more than 3 days, or if any redness or swelling occurs. New symptoms that arise should also prompt a consultation with a healthcare provider.

Patients should be made aware that if a cough returns or occurs with a rash or headache that lasts, they should seek medical attention, as these may indicate a serious condition. When using this product, patients must be reminded not to exceed the recommended dosage.

Healthcare providers should encourage patients to consult a doctor before using this product 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 cough that produces excessive phlegm or those with breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should also seek medical advice prior to use.

Finally, patients should be advised to consult a doctor or pharmacist before using this product if they are taking the blood-thinning medication warfarin, any other oral nasal decongestant or stimulant, or any other pain reliever or fever reducer.

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 it is not refrigerated. Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

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, regardless of the presence of symptoms.

Drug Information (PDF)

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

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