Cold and Flu Non Drowsy Daytime and Nighttime

Description

The product identified by SPL code 34089-3 is formulated as DT NT Cold Flu VH. This formulation is designed to address symptoms associated with cold and flu conditions.

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, and nasal congestion during daytime use. Additionally, it addresses runny nose and sneezing for nighttime relief.

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 is contraindicated for children under 4 years of age.

It is imperative to adhere strictly to the dosing instructions provided and to be aware of the overdose warning associated with this medication.

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

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, seek guidance from a healthcare professional.

• In individuals with a known history of allergic reactions to this product or any of its components, to prevent potential severe allergic responses.

• For use in children to induce sleep, as this is not an approved indication for this product.

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

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 may also lead to severe skin reactions. Symptoms indicative of such reactions 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, patients are advised to consult a physician without delay.

General precautions include the necessity for patients to avoid exceeding the directed dosage. Marked drowsiness may occur, particularly when taken at night, and patients should refrain from consuming alcoholic beverages during this time. Additionally, excitability may be observed, especially in pediatric patients. Caution is advised when driving or operating machinery due to potential drowsiness. The concomitant use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

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 signs or symptoms are apparent, as prompt intervention is vital for both adults and children.

Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness during the day. They should also seek medical advice 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, or if new symptoms develop. A return of cough accompanied by rash or headache that persists should also prompt immediate medical consultation, as these may indicate a serious underlying condition.

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.

Additionally, if a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

Patients are advised to stop use and contact 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 symptoms, 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. Redness or swelling, the emergence of new symptoms, or a cough that recurs or occurs with a rash or headache that lasts should also prompt consultation with a healthcare provider, as these may indicate a serious condition.

An overdose warning is in place, as 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 medical help 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 initially apparent.

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 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 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, 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 if no signs or symptoms are present.

Geriatric Use

Elderly patients may not have specific geriatric use information, dosage adjustments, or safety concerns outlined in the prescribing information. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the general considerations for 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 on 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 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 individuals with reduced kidney function, as the absence of detailed guidance 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 4 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 3 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 when using this medication. Taking more than the directed dosage can lead to serious health complications.

In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center. Quick medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent. Prompt intervention can significantly impact the outcome and mitigate potential health risks associated with overdose.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

Postmarketing experience has identified the potential for severe skin reactions associated with acetaminophen use. Reported symptoms of 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, there is a warning regarding the risks associated with overdose. Taking acetaminophen in excess of the recommended dosage can lead to serious health complications. In cases of suspected overdose, it is crucial to obtain medical help or contact a Poison Control Center promptly, as timely medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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.

Patients should be informed that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. It is important for patients to verify with 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 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 seek medical advice if pain, nasal congestion, or cough worsens or persists for more than seven days. For nighttime use, patients should stop use and consult a doctor if pain or cough worsens or lasts more than seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, or if new symptoms develop. Patients should be particularly vigilant for the return of cough or the occurrence of a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients should adhere strictly to the recommended dosage and be aware that marked drowsiness may occur, particularly with nighttime use. They should be advised to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Patients should also be cautioned about potential excitability, especially in children, and should exercise caution when driving or operating machinery.

Patients should be encouraged 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 gland, 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 seek medical advice if they have a breathing problem or chronic cough, or if they have glaucoma. Lastly, patients should consult a doctor or pharmacist if they are taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted, ensuring straightforward management within standard storage conditions.

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.

View product document (PDF)