Daytime Severe Cold and Flu Relief

Description

SPL code 34089-3 corresponds to CVS DT Severe, a pharmaceutical product. The formulation is designed for specific therapeutic applications, although detailed information regarding its molecular weight, chemical formula, and dosage form is not provided in the extracted data. Further specifications regarding the appearance and inactive ingredients are also not included.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates nasal congestion, sinus congestion and pressure, cough due to minor throat and bronchial irritation, minor aches and pains, headache, fever, and sore throat.

Additionally, this drug reduces swelling of the nasal passages and temporarily restores freer breathing through the nose. It promotes nasal and/or sinus drainage and assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of bothersome mucus and enhancing the productivity of coughs.

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

Dosage and Administration

Patients should take the medication only as directed. The maximum dosage should not exceed 8 softgels within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours as needed.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing recommendations.

The medication is not intended for use in children under 4 years of age.

When using other nighttime or daytime products, healthcare professionals should instruct patients to carefully read each label to ensure correct dosing and avoid potential overdosing.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited 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.

• The product should not be used in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

This product contains acetaminophen, which carries specific warnings and precautions that healthcare professionals should be aware of to ensure safe use.

Liver Warning Severe liver damage may occur if the maximum daily dosage of 8 softgels is exceeded within a 24-hour period. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if the patient consumes three 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 of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare provider promptly.

General Precautions Prior to use, patients should be advised to consult a healthcare professional if they have any of the following conditions: liver disease, diabetes, heart disease, thyroid disease, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking the anticoagulant warfarin.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center without delay, as prompt intervention is vital for both adults and children, even in the absence of noticeable signs or symptoms.

Discontinuation and Consultation Patients should stop taking this product 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 a cough that recurs or is accompanied by a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed the maximum daily dosage of 8 softgels within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. In the event of an overdose, immediate medical assistance is crucial, and patients are advised to contact a Poison Control Center, even if no symptoms are initially apparent.

Patients should also be alert to the possibility of severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. If any of these symptoms occur, patients should discontinue use and seek medical help 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 are advised to consult a healthcare professional promptly.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or cough lasting more than seven days, or if fever worsens or lasts more than three days. Additionally, the presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or occurs with a rash or headache that lasts should prompt medical consultation, as these may indicate a serious condition.

Overall, careful monitoring of symptoms and adherence to recommended dosages are essential to minimize the risk of serious adverse reactions.

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 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 and effective use, as interactions could potentially alter the anticoagulant effect of warfarin.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Severe Cold and Flu Relief (acetaminohpen, dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The product is contraindicated in children under 4 years of age. For adolescents and adults aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, with a maximum of 8 softgels in a 24-hour period.

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 mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use if they experience difficulty urinating due to an enlarged prostate gland. This precaution is essential to ensure safe and effective use of the medication in individuals with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should be aware of the potential risks associated with the use of this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily amount of 8 softgels within a 24-hour period. Additionally, the risk of liver damage increases if this product is taken in conjunction with other medications containing acetaminophen or if patients consume 3 or more alcoholic drinks daily while using this product.

It is advised that patients with liver disease consult a healthcare professional before using this product. In the event of an overdose, which can lead to liver damage, immediate medical assistance should be sought, or a Poison Control Center should be contacted. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy while using this product.

Overdosage

Taking more than the recommended dose of the medication can lead to significant liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Healthcare professionals should be aware that early recognition and management of overdose symptoms can be vital in preventing severe complications. It is recommended that patients or caregivers be educated on the importance of adhering to prescribed dosages and the potential risks associated with exceeding these limits.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose can lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use 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 be encouraged to consult a doctor or pharmacist for clarification.

It is important to instruct patients not to use this product 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 includes an MAOI.

Patients should be counseled to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or cough lasting more than seven days. Additionally, they should seek medical advice if fever worsens or persists beyond three days, if redness or swelling occurs, if new symptoms develop, or if a cough returns with a rash or headache that lasts.

While using this product, patients must be reminded to adhere strictly to the directed dosage and not exceed it.

Healthcare providers should also recommend that patients consult a doctor before using this product if they have any of the following conditions: liver disease, diabetes, heart disease, thyroid disease, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Patients with a cough that produces excessive phlegm should also seek medical advice prior to use.

Finally, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist before using this product to avoid potential interactions.

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 to maintain its integrity and efficacy. Proper handling should be observed to ensure optimal conditions are met throughout the storage period.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)