Cold and Flu Daytime Severe, 24/7 Life

Description

Cold & Flu DayTime Severe is a combination medication formulated to provide relief from multiple symptoms associated with colds and flu. Each caplet contains acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; guaifenesin, an expectorant; and phenylephrine HCl, a nasal decongestant. This formulation is designed to alleviate headache, fever, sore throat, minor aches and pains, chest congestion, nasal congestion, sinus pressure, and cough. The product is supplied in a package containing 16 caplets.

Uses and Indications

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

Additionally, this drug reduces swelling of the nasal passages, temporarily restores freer breathing through the nose, promotes nasal and/or sinus drainage, and helps loosen phlegm (mucus) while thinning bronchial secretions. This action aids in clearing the bronchial passageways of bothersome mucus, thereby making coughs more productive.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the prescribed dosage is 2 caplets taken with water every 4 hours, not to exceed 8 caplets within a 24-hour period.

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

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. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. Patients should verify with a healthcare provider if their current medications include an MAOI.

• History of allergic reactions to this product or any of its components, as this may result in severe hypersensitivity reactions.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks for liver damage. Healthcare professionals should advise patients that severe liver damage may occur if they 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 alerted to the potential for severe skin reactions associated with acetaminophen. Symptoms may include blisters, rash, and skin reddening. In the event of a skin reaction, patients must 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, patients should be instructed to consult a healthcare provider promptly.

General precautions are essential for safe use. Patients should be advised to consult a physician before using this product if they have any of the following conditions: liver disease, thyroid disease, diabetes, heart disease, high blood pressure, difficulty urinating due to prostate enlargement, or a cough that produces excessive phlegm. Additionally, those with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice prior to use. It is also important to consult a doctor or pharmacist if the patient is taking the anticoagulant warfarin.

In the event of an accidental overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center or seek emergency medical help, regardless of whether they exhibit signs or symptoms of overdose.

Patients should discontinue use and contact 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 develop; 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 further evaluation.

Side Effects

Patients using this product should be aware of potential adverse reactions, which can range from serious to common.

Severe liver damage is a significant concern associated with the use of this product, particularly due to its acetaminophen content. Patients are advised that severe liver damage may occur if they 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.

Additionally, there is an allergy alert regarding the potential for severe skin reactions. Symptoms indicative of such reactions may include blisters, rash, and skin reddening. Should any of these symptoms arise, patients are instructed to discontinue use immediately and seek medical assistance.

Patients should also be vigilant for other adverse reactions that warrant discontinuation of the product and consultation with a healthcare provider. These include the onset of nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than seven days; fever that worsens or persists beyond three days; the presence of redness or swelling; the emergence of new symptoms; or a cough that recurs or is accompanied by a rash or headache lasting for an extended period. These symptoms may indicate a serious underlying condition that requires medical evaluation.

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 or emotional conditions, or Parkinson’s disease. Additionally, it should not be administered within 2 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 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 Cold and Flu Daytime Severe, 24/7 Life (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet). 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 taken with water every 4 hours, with a maximum of 8 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 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 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.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• Patients should not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period.

• Concurrent use with other medications containing acetaminophen is contraindicated, as this may lead to unintentional overdose and increased risk of liver injury.

• Consumption of three or more alcoholic drinks per day while using this product is not recommended, as it may exacerbate the risk of liver damage.

Additionally, patients with a known history of liver disease should consult a healthcare professional prior to using this product to ensure safety and appropriateness of treatment. Regular monitoring of liver function may be warranted in patients with compromised liver function to detect any potential adverse effects early.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals are advised to remain vigilant and proactive in managing potential overdose situations. Early recognition and treatment can significantly mitigate the risks associated with overdose, ensuring the safety and well-being of the affected individual.

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 rare cases of severe skin reactions associated with acetaminophen. Reported symptoms include blisters, rash, and skin reddening. These events were documented through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an accidental overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are present.

Patients should be informed 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 consult a doctor or pharmacist for clarification.

It is essential to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. Patients should be encouraged to ask 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 advised against its use. Additionally, they should be instructed to stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

Healthcare providers should inform patients to discontinue use and seek medical advice if pain, nasal congestion, or cough worsens or persists for more than seven days. Patients should also be advised to stop use and consult a doctor if fever worsens or lasts more than three days, or if any redness or swelling occurs. New symptoms that arise should prompt a discussion with a healthcare provider, as well as a cough that returns or occurs with a rash or headache lasting for an extended period, as these may indicate a serious condition.

Patients must be reminded not to exceed the recommended dosage while using this product. It is also important for healthcare providers to ask patients about any existing liver disease, thyroid disease, diabetes, heart disease, high blood pressure, or difficulty urinating due to prostate gland enlargement before recommending this product. Patients with a cough accompanied by excessive phlegm or a persistent or chronic cough, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, should also consult a doctor prior to use.

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 upon request. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product safety.

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 accidental overdose, patients should seek medical assistance or contact a Poison Control Center immediately, 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 Cold and Flu Daytime Severe, 24/7 Life, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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