Good Sense Severe Daytime Cold and Flu

Description

GOODSENSE® is a maximum strength formulation designed for the relief of severe daytime cold and flu symptoms. This non-drowsy medication combines multiple active ingredients, including acetaminophen, dextromethorphan HBr, guaifenesin, and phenylephrine HCl, to provide comprehensive relief from headache, fever, sore throat, minor aches and pains, chest congestion, cough, and nasal/sinus congestion with associated sinus pressure. The product is presented in a liquid dosage form, with a total volume of 8 FL OZ (237 mL), and is alcohol-free. It is comparable to the active ingredients found in Vicks® DayQuil® Severe.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it addresses the following symptoms: sinus congestion and pressure, nasal congestion, minor aches and pains, headache, sore throat, and fever. Additionally, it reduces swelling of the nasal passages, promotes nasal and/or sinus drainage, and temporarily restores freer breathing through the nose. The formulation also aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of bothersome mucus and making coughs more productive due to minor throat and bronchial irritation.

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

Dosage and Administration

Patients should adhere strictly to the prescribed dosage and administration guidelines. It is imperative to utilize only the dose cup provided with the medication to ensure accurate dosing. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a physician for appropriate dosing recommendations. The medication is not indicated for use in children under 4 years of age.

Healthcare professionals should monitor patients for adherence to these guidelines to prevent 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.

Warnings and Precautions

Severe liver damage may occur with the use of this product containing acetaminophen under certain conditions. Adults should not exceed 4,000 mg of acetaminophen within a 24-hour period. For children, the maximum is 5 doses in the same timeframe. Caution is advised when this product is taken in conjunction with other medications containing acetaminophen. Additionally, adults consuming three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Patients with persistent or chronic coughs, such as those resulting from smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice before using this product. Furthermore, individuals taking the anticoagulant warfarin should consult a healthcare provider or pharmacist before use.

In cases of overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center at 1-800-222-1222 without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients are advised to discontinue use and contact their healthcare provider if they experience any of the following: increased nervousness, dizziness, or sleeplessness; worsening fever lasting more than three days; presence of redness or swelling; emergence of new symptoms; or if pain, nasal congestion, or cough worsens or persists beyond five days in children or seven days in adults. A return of cough accompanied by rash or headache that lasts may indicate a serious condition requiring medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen, specifically if an adult takes more than 4,000 mg within a 24-hour period, a child takes more than five doses in the same timeframe, or if the product is used concurrently with other medications containing acetaminophen. Additionally, adults who consume three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

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 warning is also in place; if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider promptly.

Patients are advised to stop use and seek medical advice if they experience symptoms such as nervousness, dizziness, or sleeplessness; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms arise; or if pain, nasal congestion, or cough worsens or persists beyond five days in children or seven days in adults. A cough that recurs or occurs with a rash or headache lasting longer than expected may indicate a serious condition.

Before using this product, patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or urinary issues due to an enlarged prostate gland should consult a healthcare provider. Additionally, those experiencing a cough with excessive phlegm or a persistent cough related to smoking, asthma, chronic bronchitis, or emphysema should seek medical advice prior to use.

Patients taking the blood-thinning medication warfarin should also consult a doctor or pharmacist before using acetaminophen.

In cases of overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek medical help right away, even if no signs or symptoms are present, as quick intervention is critical for both adults and children.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently taking warfarin, a blood-thinning medication. The combination may increase the risk of bleeding, necessitating careful monitoring and potential dosage adjustments.

Additionally, the use of this product is contraindicated in patients who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease. If there is uncertainty regarding the presence of an MAOI in a prescription medication, patients are advised to seek guidance from a healthcare provider or pharmacist before initiating use of this product.

Packaging & NDC

Below are the non-prescription pack sizes of Good Sense Severe Daytime Cold and Flu (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered a dosage of 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a healthcare professional before use. The medication is not recommended for children under 4 years of age.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, dosage adjustments, safety concerns, or special precautions associated with the use of this medication. 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 variability in drug metabolism and sensitivity 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 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 should consult a healthcare professional prior to use if they experience difficulty urinating due to an enlarged prostate gland. This precaution is essential to ensure appropriate management and monitoring of their condition, as reduced kidney function may influence the pharmacokinetics and safety profile of the medication.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance, as their liver function may affect the pharmacokinetics and safety profile of the drug. Monitoring of liver function tests may be warranted to ensure the safe use of the medication in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Furthermore, there is no information available related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the potential for severe skin reactions associated with acetaminophen use. Reported symptoms of these reactions 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, it is recommended to stop use and consult a healthcare professional if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults. A return of cough or the occurrence of cough alongside a rash or headache that lasts may indicate a serious condition, warranting further medical evaluation.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should consult a doctor or pharmacist for clarification.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised against its use. Additionally, they should be instructed to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness.

Healthcare providers should inform patients to stop using the product and seek medical advice if their fever worsens or persists for more than three days, if they notice any redness or swelling, or if new symptoms arise. Patients should also be cautioned to stop use and consult a doctor if pain, nasal congestion, or cough worsens or lasts longer than five days in children or seven days in adults. They should be made aware that a returning cough or one accompanied by a rash or persistent headache may indicate a serious condition, warranting immediate medical attention.

When using this product, patients should be reminded to adhere strictly to the recommended dosage and not exceed the directed amount.

Healthcare providers should encourage patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients should also be advised to seek medical advice if they have a cough associated with excessive phlegm or a persistent cough related to smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in the following configurations: insert NDC numbers or packaging details here. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling should be observed to maintain the quality and efficacy of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines based on age. Adults and children aged 12 years and older are advised to take 30 mL every 4 hours, while children aged 6 to under 12 years should take 15 mL every 4 hours. For children aged 4 to under 6 years, consultation with a doctor is recommended, and the medication is not to be used in children under 4 years of age.

Clinicians should counsel patients regarding the importance of consulting a health professional if pregnant or breastfeeding. It is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

This file contains official product information for Good Sense Severe Daytime Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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