Cold and Flu Non Drowsy Day Relief and Night Relief

Description

Cold and flu day and night is a pharmaceutical formulation designed to provide symptomatic relief from cold and flu symptoms. This product is intended for use during both daytime and nighttime, addressing the varying needs of patients throughout the day. The formulation is designed to alleviate symptoms such as congestion, cough, and fever, while also promoting restful sleep during nighttime use.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates fever, headache, minor aches and pains, cough due to minor throat and bronchial irritation, sore throat, nasal congestion (for daytime use only), and runny nose and sneezing (for nighttime use only).

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

Dosage and Administration

For daytime use, the medication should be administered as directed, adhering to the overdose warning. Adults and children aged 12 years and older are instructed to take 2 softgels with water every 4 hours, with a maximum of 4 doses within a 24-hour period. For children aged 4 to under 12 years, consultation with a healthcare professional is recommended prior to use. The medication is not indicated for children under 4 years of age.

For nighttime use, the same precautions apply regarding administration as directed and the overdose warning. Adults and children aged 12 years and older should take 2 softgels with water every 6 hours, ensuring that the total does not exceed 4 doses in a 24-hour period. As with daytime dosing, children aged 4 to under 12 years should seek advice from a healthcare provider before use, and the medication is contraindicated for children under 4 years of age.

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 uncertain about the presence of acetaminophen in a medication, consult a healthcare professional.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious interactions.

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

• Use in children for the purpose of inducing sleep is contraindicated, as it is not intended for this indication.

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 recommended dosage, which is a maximum of 4 doses within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications that contain acetaminophen or if they consume three or more alcoholic beverages daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, 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, it is imperative for patients to consult a healthcare provider without delay.

Healthcare professionals should emphasize the importance of adhering to the prescribed dosage, as exceeding the recommended amount can lead to serious health complications. In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help, even if no symptoms are apparent, as prompt intervention is essential for both adults and children.

Patients should be advised to discontinue use and consult a healthcare provider if they experience any of the following: nervousness, dizziness, or sleeplessness during the day; worsening pain, nasal congestion, or cough lasting more than seven days during the day; worsening pain or cough lasting more than seven days at night; fever that worsens or persists for more than three days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or a persistent headache. These symptoms may indicate a serious underlying condition.

In the event of a skin reaction, patients must stop using the product and seek emergency medical help immediately.

Side Effects

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

A sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting warrants prompt consultation with a healthcare provider.

Patients are advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness during the daytime, or if pain, nasal congestion, or cough worsens or lasts more than seven days during the daytime. For nighttime use, if pain or cough worsens or persists beyond seven days, or if fever worsens or lasts more than three days, medical advice should be sought. 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 be evaluated by a healthcare professional, as these may indicate a serious condition.

Patients should also be cautioned against taking more than the directed dosage, as this can lead to serious health complications. In the event of an overdose, immediate medical attention is critical for both adults and children, even if no signs or symptoms are apparent. It is recommended to contact a Poison Control Center without delay.

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 and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. This combination may lead to serious and potentially life-threatening interactions.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, caution is advised for patients who are using sedatives or tranquilizers, particularly at nighttime. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, which could impair the ability to perform tasks requiring alertness. Monitoring for increased sedation and potential respiratory depression is recommended in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Flu Non Drowsy Day Relief and Night Relief (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, 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 patients aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours during the daytime or every 6 hours at nighttime.

Healthcare professionals should be aware of the overdose warning associated with this medication. Taking more than the directed dosage can lead to serious health complications. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Prompt medical attention is crucial for both adults and pediatric patients, even if no signs or symptoms are initially apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments or safety considerations based on the information provided. The prescribing information does not outline any special precautions or recommendations tailored for geriatric patients.

However, it is important to note that general warnings included in the prescribing information may be relevant to elderly patients. For instance, the liver warning associated with acetaminophen usage should be considered, as older adults may have an increased sensitivity to side effects. Healthcare providers are advised to monitor elderly patients closely for any adverse reactions, given their potential for heightened sensitivity.

In summary, while there are no explicit geriatric-specific guidelines, caution is warranted when prescribing to elderly patients, particularly in relation to the general warnings outlined in the prescribing information.

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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 that patients do not exceed four doses within a 24-hour period, as this represents the maximum daily amount for this product. Additionally, patients should avoid concomitant use with other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

Overdosage

Overdose warning is a critical consideration for healthcare professionals when prescribing or advising on medication use. Taking more than the directed dosage can lead to serious health complications, necessitating immediate action.

In the event of an overdose, it is imperative to seek medical assistance or contact a Poison Control Center without delay. Quick medical attention is essential for both adults and children, even in instances where no signs or symptoms are immediately apparent. The potential for serious health issues underscores the importance of vigilance and prompt intervention in overdose situations.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, the assessment of potential risks related to these aspects remains unaddressed.

Postmarketing Experience

Postmarketing experience has identified the potential for severe skin reactions associated with acetaminophen use, which may manifest as skin reddening, blisters, or rash. In the event of such reactions, it is advised to discontinue use and seek immediate medical assistance.

Additionally, reports indicate that exceeding the recommended dosage can lead to serious health complications. In cases of overdose, prompt medical attention is essential, and individuals are encouraged to contact a Poison Control Center without delay, as timely intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Healthcare professionals are advised to recommend discontinuation of acetaminophen and consultation with a physician if patients experience symptoms such as nervousness, dizziness, or sleeplessness during the daytime, worsening pain, nasal congestion, or cough lasting more than seven days, fever persisting beyond three days, or the emergence of new symptoms. The recurrence of cough accompanied by rash or headache that persists should also prompt further evaluation, as these may indicate a serious underlying condition.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to instruct patients not to exceed the recommended dosage, as taking more than directed can lead to adverse effects.

Patients should be informed that marked drowsiness may occur, particularly when the medication is taken at night. They should be cautioned to avoid consuming alcoholic beverages during this time, as alcohol can exacerbate drowsiness. Additionally, healthcare providers should discuss the potential for excitability, especially in children, which may occur as a side effect.

Patients should also be made aware of the need for caution when driving a motor vehicle or operating machinery after taking the medication at night, due to the risk of impaired alertness. Furthermore, it is essential to inform patients that the use of alcohol, sedatives, and tranquilizers in conjunction with this medication may further increase drowsiness, and they should be advised to avoid such combinations.

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

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the medication out of reach of children to ensure safety. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

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