Cold and Flu Non Drowsy Daytime and Nighttime

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided.

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 contraindicated for 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 guidance 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, do not exceed the recommended dosage and 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 taking this product in conjunction with other medications containing acetaminophen, as this increases the risk of liver injury. Additionally, consumption of three or more alcoholic drinks daily while using this product may exacerbate the risk of liver damage.

Acetaminophen may also provoke 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 should be advised to consult a healthcare provider without delay.

General precautions should be emphasized to patients. They must not exceed the directed dosage. Marked drowsiness may occur, particularly when taken at night, and patients should be cautioned to avoid alcoholic beverages during this time. Excitability may be observed, especially in pediatric patients, and care should be taken when driving or operating machinery. The concomitant use of alcohol, sedatives, and tranquilizers may enhance 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 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. 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. Signs of redness or swelling, the emergence of new symptoms, or a cough that recurs with a rash or headache warrant immediate medical evaluation, 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.

In cases where a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should discontinue 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 with a rash or headache lasting longer than expected may indicate a serious condition requiring medical evaluation.

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 crucial, and patients should contact a Poison Control Center without delay, even if no signs or symptoms are apparent. Quick medical intervention is essential 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, and for a period of two weeks following the discontinuation of the MAOI. This interaction may lead to serious and potentially life-threatening side effects.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding.

Additionally, caution is advised for individuals using sedatives or tranquilizers, particularly at nighttime. The combination of this medication with alcohol, sedatives, or tranquilizers may enhance drowsiness, necessitating careful monitoring of sedation levels and potential impairment of motor skills.

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, 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 have specific dosage adjustments or safety concerns outlined for the use of this product; however, caution is advised due to the potential for increased sensitivity to certain effects. The product is indicated for adults and children aged 12 years and older, with a recommended dosage of 2 softgels taken with water every 4 hours during the daytime and every 6 hours at nighttime, not exceeding 4 doses within a 24-hour period.

It is important for healthcare providers to consider that elderly patients may have underlying health conditions that could influence the safety and efficacy of the product. For instance, patients with liver disease should consult a physician prior to use, as this condition may be more prevalent among older adults. Additionally, caution is warranted for those with heart disease, high blood pressure, or thyroid disease, which are also more common in this population.

Marked drowsiness may occur with nighttime use, presenting a potential risk for elderly patients who may be more susceptible to sedation. The concomitant use of alcohol, sedatives, or tranquilizers can further enhance drowsiness, necessitating careful monitoring and consideration of these factors in geriatric patients.

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 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 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 the use of this medication. Taking more than the directed dosage can lead to serious health problems, which may vary in severity depending on the amount ingested and the individual patient's circumstances.

In the event of an overdose, it is imperative to seek medical assistance immediately. Healthcare providers should advise patients or caregivers to 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. Early intervention can significantly impact the outcome and mitigate potential complications associated with an overdose.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of acetaminophen. Notably, severe skin reactions have been reported, which include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of acetaminophen be discontinued immediately, and medical assistance should be sought without delay.

Patient Counseling

Patients should be advised to keep this product out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. They should be encouraged to ask their healthcare provider if they are unsure whether their prescription medication contains an MAOI. Additionally, patients with a history of allergic reactions to this product or any of its ingredients should not use it.

Healthcare providers should emphasize that this product is not intended to induce sleepiness in children and should not be used for that purpose. Patients should be instructed to stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness during the day. 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, new symptoms, or a cough that returns or occurs with a rash or headache should prompt a consultation with a healthcare provider, as these may indicate a serious condition.

Patients must be reminded to adhere to the recommended dosage and not exceed it. They should be informed that marked drowsiness may occur when using this product at night, and they should avoid alcoholic beverages during this time. Patients should also be made aware that excitability may occur, particularly in children, and they should exercise caution when driving or operating machinery. The use of alcohol, sedatives, and tranquilizers may enhance drowsiness, and patients should be advised accordingly.

Before using this product, patients should consult a doctor 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 seek medical advice if they have a breathing problem or chronic cough, or if they have glaucoma. Furthermore, patients taking the blood-thinning medication warfarin or any sedatives or tranquilizers should consult a doctor or pharmacist prior to use.

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; however, standard precautions should be observed to ensure optimal 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.

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