Cold and Flu Daytime-Nighttime

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 addresses the following symptoms: 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, temporarily restores freer breathing through the nose, promotes nasal and/or sinus drainage, and helps to loosen phlegm (mucus) and thin 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

The medication should be taken only as directed. For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, not to exceed 8 softgels within a 24-hour period.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing. The use of this medication is not recommended for children under 4 years of age.

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

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, and for a period of 2 weeks following the discontinuation of the MAOI. This is due to the potential for serious interactions. If there is uncertainty about whether a prescription drug contains an MAOI, a healthcare professional should be consulted prior to use.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the maximum daily dosage of 8 softgels within a 24-hour period. Caution is warranted if the patient is concurrently using other medications containing acetaminophen or consuming three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. If any of these reactions occur, patients should be instructed to 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 advised to consult a physician promptly.

General precautions should be taken for patients with specific medical conditions. Prior to use, patients should be encouraged to consult a healthcare provider if they have 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, those with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice before using this product. It is also important to consult a doctor or pharmacist if the patient is taking the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help, regardless of the presence of symptoms.

Patients should discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if fever worsens or lasts more than three days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a cough that recurs with a rash or headache that lasts should also prompt a consultation, as these may indicate a serious condition.

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur if patients exceed the maximum daily dosage of 8 softgels 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 aware of the potential for severe skin reactions related to acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Additionally, if 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.

Common adverse reactions that warrant discontinuation of use and consultation with a doctor include symptoms such as nervousness, dizziness, or sleeplessness. Patients should also seek medical advice if pain, nasal congestion, or cough worsens or lasts longer than seven days, if fever worsens or persists beyond 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.

Patients with pre-existing conditions should consult a doctor before using this product if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Furthermore, those experiencing a cough with excessive phlegm or a persistent cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use.

It is advisable for patients to consult a doctor or pharmacist before using this product if they are concurrently taking the blood-thinning medication warfarin.

Drug Interactions

Acetaminophen has the potential to increase the risk of severe liver damage when used concurrently with other products containing acetaminophen or in individuals consuming three or more alcoholic beverages daily. It is advisable for patients to avoid combining these substances to mitigate the risk of hepatotoxicity.

Dextromethorphan may interact with monoamine oxidase inhibitors (MAOIs), which can lead to serious adverse effects. Patients are strongly advised to avoid the use of dextromethorphan if they are currently taking MAOIs or have discontinued them within the past two weeks.

Patients taking warfarin should seek consultation with a healthcare professional, such as a doctor or pharmacist, prior to using products that contain acetaminophen or dextromethorphan, as these substances may affect anticoagulation therapy.

Doxylamine may enhance drowsiness when taken in conjunction with alcohol, sedatives, or tranquilizers. Caution is recommended for individuals who need to drive or operate machinery while using doxylamine in combination with these substances.

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Flu Daytime-Nighttime (acetaminophen, dextromethorphan hbr, doxylamine succinate, 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 adults and children aged 12 years and older, the recommended dosage is 2 softgels with water every 4 hours.

Caution is advised as excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients should consult a healthcare provider prior to 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 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 before use.

It is also advisable for geriatric patients to consult a doctor or pharmacist if they are currently taking the anticoagulant medication warfarin, as interactions may occur.

When using this product, elderly patients must adhere strictly to the recommended dosage and should not exceed the directed amount. Marked drowsiness may be experienced, and it is recommended to avoid alcoholic beverages during use. Caution is advised when driving or operating machinery, as the effects of alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Regular monitoring and careful consideration of these factors are essential to ensure the safety and well-being of geriatric patients.

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, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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 individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulties with urination due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's specific condition.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is crucial for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• The maximum recommended dosage is 8 softgels in a 24-hour period. Exceeding this dosage may lead to severe liver damage.

• Patients should avoid concomitant use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

• Consumption of 3 or more alcoholic drinks daily while using this product is not advised, as it may exacerbate the potential for liver damage.

Additionally, patients with a history of liver disease should consult a healthcare professional before using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in patients with compromised liver function to detect any potential adverse effects promptly.

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

If pregnant or breast-feeding, it is advised to consult a health professional prior to use.

Acetaminophen has been associated with severe skin reactions, 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. Additionally, excitability may be observed, particularly in children, and marked drowsiness can occur. The concomitant use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

No specific nonclinical toxicology data or animal pharmacology and toxicology data have been provided in the insert.

Postmarketing Experience

Severe skin reactions have been reported in postmarketing experience with acetaminophen. Symptoms associated with these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, excitability has been noted, particularly in pediatric populations. Marked drowsiness is another effect that may occur. The concomitant use of alcohol, sedatives, and tranquilizers has been observed to potentially enhance drowsiness.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, 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 about the presence of acetaminophen in their medications, they should be encouraged to consult with a doctor or pharmacist.

It is important 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 advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be counseled to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop use 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 that arise should also prompt a consultation with a healthcare provider.

Patients should be made aware that if a cough returns or occurs alongside a rash or persistent headache, they should seek medical attention, as these may indicate a serious condition. It is essential to emphasize that patients should not exceed the recommended dosage when using this product.

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 a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, 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.

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 a temperature not exceeding 25°C to maintain its integrity and efficacy. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

Adults and children aged 12 years and older are advised to take 2 softgels with water every 4 hours. For children aged 4 to under 12 years, it is recommended to consult a doctor before administration, while the product should not be used in children under 4 years of age.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

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