Non Drowsy Day and Night Multi-Symptom Cold and Flu Formula

Description

The product is identified by the SPL Code 34089-3 and is available in a combination pack containing 20 units. This formulation is designed for both daytime and nighttime use, providing a dual-action approach to address specific health needs.

Uses and Indications

DAY COLD & FLU FORMULA is indicated for the temporary relief of symptoms associated with the common cold or influenza, including minor aches and pains, headache, cough, sore throat, nasal and sinus congestion, and the temporary reduction of fever.

NIGHT COLD & FLU FORMULA is indicated for the relief of cold and flu symptoms and includes a pain reliever/fever reducer, cough suppressant, antihistamine, and nasal decongestant.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 softgels of the Day Cold & Flu Formula with water every 4 hours, ensuring that the total does not exceed 10 softgels within a 24-hour period, unless otherwise directed by a healthcare professional. The use of this formulation is not recommended for children under 12 years of age.

For the Nighttime Cold & Flu Formula, adults and children aged 12 years and older should also take 2 softgels with water every 4 hours, adhering to the same maximum limit of 10 softgels in a 24-hour period, unless otherwise instructed by a healthcare provider. This formulation is contraindicated for children under 12 years.

Contraindications

DAY COLD & FLU FORMULA is contraindicated in the following situations:

• Concurrent use with any other drug containing acetaminophen, due to the risk of acetaminophen overdose.

• Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, as this may lead to serious interactions.

• Individuals with a history of allergic reactions to this product or any of its ingredients.

• Children under 12 years of age.

NIGHTTIME COLD & FLU FORMULA is contraindicated in the following situations:

• Concurrent use with any other drug containing acetaminophen, due to the risk of acetaminophen overdose.

• Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, as this may lead to serious interactions.

• Individuals with a history of allergic reactions to this product or any of its ingredients.

• Children under 12 years of age.

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 10 softgels within a 24-hour period. Caution is warranted if the patient is concurrently using other medications that contain acetaminophen, as this may increase the risk of liver injury. Additionally, patients should be informed that consuming three or more alcoholic drinks daily while using this product can exacerbate the risk of liver damage.

In cases of severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a healthcare provider promptly.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must discontinue use immediately and seek medical assistance.

It is imperative to note that this product should not be used to sedate children.

Patients should be advised to stop taking the product and contact their healthcare provider if they experience any of the following: worsening pain, cough, or nasal congestion lasting more than seven days; fever that worsens or persists beyond three days; presence of redness or swelling; emergence of new symptoms; recurrence of cough accompanied by rash or headache lasting longer than expected; or symptoms of nervousness, dizziness, or sleeplessness. These may indicate a serious underlying condition requiring medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 10 softgels 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.

Marked drowsiness may occur when using this product. Patients are advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Caution is recommended when driving or operating machinery. Additionally, excitability has been reported, particularly in children.

Patients should stop use and consult a healthcare professional if symptoms worsen or persist. For those using the Daytime Cold & Flu Formula, they should seek medical advice if pain, cough, or nasal congestion lasts more than 7 days, if fever worsens or lasts more than 3 days, if redness or swelling is observed, if new symptoms develop, or if cough recurs with a rash or headache that persists. Similar guidance applies to the Nighttime Cold & Flu Formula, with the same criteria for seeking medical attention. Symptoms such as nervousness, dizziness, or sleeplessness should also prompt consultation with a healthcare provider.

Drug Interactions

The use of DAY COLD & FLU FORMULA and NIGHTTIME COLD & FLU FORMULA is contraindicated with any other medications containing acetaminophen, whether prescription or nonprescription. Patients should consult a healthcare professional if uncertain about the presence of acetaminophen in their medications.

Both DAY COLD & FLU FORMULA and NIGHTTIME COLD & FLU FORMULA should not be used concurrently with monoamine oxidase inhibitors (MAOIs), which are prescribed for conditions such as depression, psychiatric disorders, or Parkinson's disease. This contraindication extends to a period of two weeks following the discontinuation of an MAOI. Patients are advised to seek clarification from a healthcare provider if they are unsure whether their prescription includes an MAOI.

Caution is advised when using DAY COLD & FLU FORMULA or NIGHTTIME COLD & FLU FORMULA in conjunction with the anticoagulant warfarin. Patients should consult a doctor or pharmacist prior to use to assess potential interactions.

Additionally, the use of NIGHTTIME COLD & FLU FORMULA in combination with sedatives or tranquilizers warrants consultation with a healthcare professional due to the potential for increased drowsiness. The concurrent consumption of alcohol, sedatives, and tranquilizers may further enhance drowsiness when using NIGHTTIME COLD & FLU FORMULA.

Packaging & NDC

Below are the non-prescription pack sizes of Non Drowsy Day and Night Multi-Symptom Cold and Flu Formula (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. The DAY COLD & FLU FORMULA and NIGHTTIME COLD & FLU FORMULA are indicated for adults and children aged 12 years and older, with a recommended dosage of 2 softgels every 4 hours, not to exceed 10 softgels in a 24-hour period unless directed by a healthcare professional. There is a specific caution against using this medication to sedate children.

Geriatric Use

There is no specific geriatric use information provided in the prescribing information. The absence of recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients indicates that the available data does not suggest any particular modifications or considerations for this population. Healthcare providers should continue to exercise clinical judgment when prescribing to geriatric patients, taking into account individual patient factors and overall health status.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice 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 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 the maximum daily dosage of 10 softgels within a 24-hour period. Additionally, patients should avoid concomitant use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Prior to use, patients with known liver disease should consult a healthcare professional. During the course of treatment, it is essential for patients to adhere strictly to the recommended dosage and to refrain from consuming alcoholic beverages.

Patients are advised to discontinue use and seek medical attention if any of the following occur: worsening pain, cough, or nasal congestion lasting more than 7 days; fever that worsens or persists for more than 3 days; the presence of redness or swelling; the emergence of new symptoms; or if a cough recurs or is accompanied by a rash or headache that lasts. Monitoring for these symptoms is important to ensure patient safety and to mitigate the risk of potential complications associated with hepatic impairment.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product.

Risk of Severe Liver Damage Taking more than 10 softgels within a 24-hour period, which exceeds the maximum recommended daily dosage, can lead to severe liver damage. Healthcare professionals should be vigilant in assessing patients who may have exceeded this limit.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a further risk of severe liver damage. It is crucial for healthcare providers to inquire about all medications a patient is taking to prevent potential interactions that could exacerbate liver toxicity.

Furthermore, patients who consume three or more alcoholic drinks daily while using this product are at an increased risk of severe liver damage. Healthcare professionals should advise patients on the dangers of alcohol consumption in conjunction with this medication and monitor for signs of liver impairment.

In the event of suspected overdosage, immediate medical attention is warranted. Monitoring liver function tests and providing supportive care are essential components of management.

Nonclinical Toxicology

If pregnant or breastfeeding, 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. Reports indicate that symptoms 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 reported, particularly in pediatric populations.

Patient Counseling

Healthcare providers should advise patients to consult a health professional if they are pregnant or breastfeeding before using the medication. It is important for patients to understand the potential risks and benefits associated with the use of the medication during these periods.

Additionally, patients should be encouraged to speak with their doctor or pharmacist prior to use if they are currently taking the blood-thinning medication warfarin. This is crucial to ensure that there are no interactions that could affect their health.

Furthermore, healthcare providers should recommend that patients consult with their doctor or pharmacist if they are using sedatives or tranquilizers. This precaution helps to identify any possible interactions that may arise from concurrent use of these medications.

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, ensuring that it is kept away from excessive heat to maintain its integrity and efficacy. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 softgels with water every 4 hours, with a maximum of 10 softgels in a 24-hour period unless directed otherwise by a healthcare professional. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

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