Daytime Non-Drowsy Cold and Flu

Description

No description information is available for the specified drug.

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, cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, and fever.

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

Dosage and Administration

Patients should take the medication only as directed, adhering to the overdose warning. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is to swallow two softgels with water every four hours.

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

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

When utilizing other Daytime or Nighttime products, it is essential to carefully read each label to ensure correct dosing and avoid exceeding the recommended limits.

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, or 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.

• Additionally, the product should not be used in excess of the recommended dosage.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4 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.

Healthcare professionals should advise patients to seek medical attention promptly if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. Overdosing on this product can lead to serious health complications; therefore, in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential. Quick medical intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

General precautions must be observed. This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare provider or pharmacist is recommended. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Patients should inquire with their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Before using this product, patients should consult a healthcare professional if they have any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, difficulty urinating due to an enlarged prostate gland, a cough associated with excessive phlegm, or a persistent or chronic cough related to smoking, asthma, or emphysema. Furthermore, patients taking the anticoagulant Warfarin should seek advice from a healthcare provider or pharmacist prior to use. It is imperative that patients adhere strictly to the recommended dosage and not exceed the directed amount.

Patients should be instructed to discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if symptoms worsen or persist beyond 5 days for children or 7 days for adults; if fever worsens or lasts more than 3 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

Severe liver damage may occur in patients who exceed the maximum daily dosage of four doses 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.

Patients should be advised to seek medical attention promptly if they experience a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the presence of acetaminophen in their medications should consult a healthcare professional. Additionally, individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or who have stopped taking an MAOI within the past two weeks should avoid this product.

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

Patients taking the blood-thinning medication Warfarin should also seek advice from a doctor or pharmacist prior to use.

While using this product, patients must adhere strictly to the recommended dosage and should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if symptoms worsen or persist beyond five days for children or seven days for adults; 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 condition.

Taking more than the directed dosage can lead to serious health complications. In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Patients taking the anticoagulant Warfarin should consult a healthcare professional prior to using acetaminophen. The interaction between these two medications may alter the anticoagulant effect of Warfarin, potentially increasing the risk of bleeding. Monitoring of INR (International Normalized Ratio) levels is advisable to ensure therapeutic efficacy and safety. Adjustments to the dosage of Warfarin may be necessary based on clinical judgment and INR results.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Non-Drowsy Cold and Flu (acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride). 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 adults and children aged 12 years and older, the recommended dosage is to swallow 2 softgels with water every 4 hours, with a maximum of 4 doses in a 24-hour period.

In pediatric patients, if symptoms worsen or persist for more than 5 days, or if fever worsens or lasts more than 3 days, it is advised to discontinue use and seek medical advice.

Geriatric Use

Elderly patients may not have specific geriatric use information available for this medication. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions pertinent to this population. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and overall health status. Regular monitoring may be advisable to ensure safety and efficacy in this demographic.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the 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.

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 dosage of 4 doses within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage.

It is recommended that patients with a history of liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss any necessary dosage adjustments or monitoring requirements.

Overdosage

Taking more than the recommended dosage can lead to serious health complications. It is imperative that healthcare professionals recognize the potential risks associated with overdosage and act promptly.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Quick intervention is crucial, as the severity of symptoms may not be immediately apparent.

Both adults and children require urgent medical evaluation following an overdose, even in the absence of noticeable signs or symptoms. This proactive approach is essential to mitigate potential health risks and ensure appropriate management of the situation.

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 several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as rash, pruritus, and urticaria. Gastrointestinal disturbances have been noted, including nausea and vomiting. Central nervous system effects reported include dizziness and drowsiness. Cardiovascular effects such as palpitations and elevated blood pressure have also been observed.

Hepatic effects, specifically elevated liver enzymes, have been documented. Renal effects, including acute kidney injury, have been reported as well. Respiratory effects, notably bronchospasm, have been identified. Skin reactions, including severe conditions such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been noted. Additionally, other reactions such as anaphylaxis and angioedema have been reported.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed 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.

It is important to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the last two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and seek medical advice if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be informed to stop using the product and consult a doctor if their symptoms worsen or persist beyond 5 days for children or 7 days for adults. If a fever worsens or lasts more than 3 days, or if there is any redness or swelling, patients should also be advised to seek medical attention. 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.

While using this product, patients should be reminded not to exceed the recommended dosage. It is essential for patients to consult a doctor before using this medication if they have any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Patients with a cough that produces excessive phlegm or a persistent cough associated with smoking, asthma, or emphysema should also seek medical advice prior to use. Lastly, patients taking the blood-thinning medication Warfarin should be encouraged 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 for identification. It is essential to store the product at room temperature, maintaining a range of 15° to 30°C (59° to 86°F). Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial to ensure the product remains effective and safe for use.

Additional Clinical Information

The medication is administered orally, with adults and children aged 12 years and older instructed to swallow 2 softgels with water every 4 hours. For children aged 4 to under 12 years, it is recommended to consult a doctor before use, while the product is not advised for children under 4 years of age.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the medication out of reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

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