Cold and Flu Non Drowsy Daytime and Nighttime

Description

DT NT Cold Flu 360 is identified by the SPL Code 34089-3. This product is formulated to address symptoms associated with cold and flu. Further details regarding its chemical composition, dosage form, and inactive ingredients are essential for comprehensive understanding and application in clinical settings.

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 recommended dosage for adults and children aged 12 years and older is to take 2 softgels with water every 4 hours, not to exceed 4 doses within a 24-hour period. For children aged 4 to under 12 years, it is advised to consult a physician before administration. The product is not intended for use in children under 4 years of age.

For nighttime use, adults and children aged 12 years and older should take 2 softgels with water every 6 hours, with a maximum of 4 doses in a 24-hour period. As with daytime dosing, parents or guardians should seek medical advice for children aged 4 to under 12 years, and the product should not be used in children under 4 years of age.

It is imperative to adhere strictly to the recommended dosages to avoid the risk of overdose.

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 other medications, 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 drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek advice from a healthcare professional.

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

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

Additionally, it is advised not to exceed the recommended dosage and to avoid alcoholic beverages while using this product.

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. Patients should be cautioned against the concurrent use of other medications containing acetaminophen, as well as the consumption of three or more alcoholic drinks 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. In the event of any skin reaction, patients must 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 healthcare provider promptly.

Healthcare professionals must emphasize the importance of adhering to the prescribed dosage, as taking more than directed 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 medical help without delay, even if no signs or symptoms are initially apparent, particularly in children.

Patients should be advised to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness during the daytime, or if pain, nasal congestion, or cough worsens or persists beyond seven days. For nighttime use, if pain or cough worsens or lasts more than seven days, or if fever worsens or lasts more than three days, medical consultation is warranted. Additionally, patients should seek medical advice if redness or swelling occurs, new symptoms develop, or if a cough recurs alongside a rash or headache that persists.

In the event of a skin reaction, immediate cessation of the product and prompt medical attention are essential.

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. 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.

An overdose of this product can lead to serious health complications. Patients are urged to seek immediate medical help or contact a Poison Control Center if an overdose is suspected, even if no signs or symptoms are apparent, as prompt medical attention is critical for both adults and children.

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 associated hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, as well as for a period of two weeks following the discontinuation of 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, as there may be an increased risk of bleeding due to potential pharmacodynamic interactions.

Additionally, caution is advised for individuals 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 Daytime and Nighttime (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 for daytime use or every 6 hours for nighttime use.

Healthcare providers 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, it is crucial to seek immediate medical assistance or contact a Poison Control Center, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Geriatric Use

There is no specific geriatric use information provided in the prescribing information for this medication. Consequently, there are no recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients mentioned. 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 warranted to ensure safety and efficacy in this population.

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 no specific data available regarding the excretion of this medication in 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 concurrent 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 if no signs or symptoms are initially apparent. The potential for serious health issues underscores the importance of vigilance and prompt intervention in overdose situations.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has revealed reports of severe skin reactions associated with acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, users are advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to keep this product 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 this product should not be used 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 medication contains an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Additionally, this product should not be used to induce sleepiness in children.

Patients should be instructed to stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness during the daytime. They should also be advised to seek medical attention if pain, nasal congestion, or cough worsens or persists for more than seven days, or if fever worsens or lasts more than three days. Any signs of redness or swelling, the emergence of new symptoms, or a cough that returns or occurs with a rash or headache should prompt patients to contact their healthcare provider, as these may indicate a serious condition.

When using this product, patients should be reminded not to exceed the recommended dosage. They should be made aware that marked drowsiness may occur, particularly when used at night, and should avoid alcoholic beverages during this time. Patients should also be informed that excitability may occur, especially in children, and they should exercise caution when driving or operating machinery.

Patients should be advised to consult a doctor before using this product if they have a cough accompanied by excessive phlegm, liver disease, difficulty urinating due to an enlarged prostate, diabetes, heart disease, thyroid disease, high blood pressure, or a persistent or chronic cough associated with smoking, asthma, or emphysema. For nighttime use, patients should also seek medical advice if they have a breathing problem or chronic cough, or if they have glaucoma.

Finally, patients should be encouraged to speak with their doctor or pharmacist if they are taking the blood-thinning medication warfarin or if they are using sedatives or tranquilizers, particularly for nighttime use.

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. No special handling requirements are necessary beyond standard storage practices.

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 Daytime and Nighttime, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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