Good Sense Night Time Cold and Flu

Description

GOOD SENSE® is a maximum strength formulation designed for the relief of symptoms associated with severe nighttime cold and flu. This product combines multiple active ingredients, including acetaminophen, phenylephrine HCl, dextromethorphan HBr, and doxylamine succinate, to provide comprehensive relief as a pain reliever, fever reducer, nasal decongestant, cough suppressant, and antihistamine. The formulation is presented in a liquid dosage form with a honey flavor, and is packaged in a 12 FL OZ (354 mL) container. This product is comparable to the active ingredients found in Vicks® NyQuil® Severe.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates nasal congestion, sinus congestion and pressure, cough due to minor throat and bronchial irritation, and cough that may interfere with sleep. Additionally, it provides relief from minor aches and pains, headaches, sore throat, fever, runny nose, and sneezing.

This medication also reduces swelling of the nasal passages, temporarily restores freer breathing through the nose, and promotes nasal and/or sinus drainage.

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:

• 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 advice 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 and may pose safety risks.

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 a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

General precautions should be taken before using this product. Patients should be advised to consult a healthcare provider if they have any of the following conditions: liver disease, heart disease, high blood pressure, glaucoma, thyroid disease, diabetes, a cough associated with excessive phlegm, difficulty urinating due to an enlarged prostate, or chronic respiratory issues such as emphysema or chronic bronchitis. Additionally, individuals with persistent or chronic coughs, such as those related to smoking, asthma, or emphysema, should seek medical advice prior to use.

Patients should also inform their doctor or pharmacist if they are currently taking blood thinners, such as warfarin, or if they are using sedatives or tranquilizers.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center at 1-800-222-1222 without delay, as quick 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 nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond five days in children or seven days in adults, or if fever worsens or lasts more than three days, medical consultation is warranted. Redness or swelling, the emergence of new symptoms, or a cough that recurs alongside a rash or headache should also prompt immediate medical evaluation, as these may indicate a serious condition.

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 5 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.

Participants in clinical trials and postmarketing experiences have reported additional adverse reactions. Patients are advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Furthermore, if pain, nasal congestion, or cough worsens or lasts beyond five days in children or seven days in adults, 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 with a rash or headache lasting longer than expected may indicate a serious condition requiring medical evaluation.

While using this product, excitability may occur, particularly in children, and marked drowsiness is a common side effect. Patients are advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Caution is recommended when driving or operating machinery.

Patients should not use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. It is advisable to consult a healthcare provider before use if there is a history of liver disease, heart disease, high blood pressure, glaucoma, thyroid disease, diabetes, or if the patient has a cough associated with excessive phlegm, difficulty urinating due to an enlarged prostate, or chronic respiratory issues such as emphysema or chronic bronchitis. Additionally, patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should seek medical advice prior to use.

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

Drug Interactions

The concomitant use of this product with warfarin, a blood-thinning agent, may elevate the risk of bleeding. It is advisable to monitor patients closely for signs of increased bleeding and consider dosage adjustments as necessary.

Co-administration with alcohol, sedatives, and tranquilizers may potentiate drowsiness. Patients should be cautioned about the potential for enhanced sedation and advised to avoid activities requiring full alertness until they understand how the combination affects them.

This product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription, to prevent the risk of acetaminophen overdose.

Prior to using this product, patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson’s disease, should consult a healthcare professional. This consultation is also recommended for patients who have discontinued MAOI therapy within the last two weeks, as interactions may still pose a risk during this period.

Packaging & NDC

Below are the non-prescription pack sizes of Good Sense Night Time Cold and Flu (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

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

Healthcare professionals should be aware that excitability may occur, particularly in pediatric patients. Additionally, marked drowsiness is a potential side effect. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics 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 associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 absence of 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 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 drug's metabolism and overall safety profile. Monitoring of liver function may be necessary to ensure the safe use of this 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

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Excitability has been observed, particularly in pediatric populations, and marked drowsiness may also occur.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is provided in the insert.

Postmarketing Experience

Postmarketing experience has identified several adverse events associated with the use of acetaminophen, reported voluntarily or through surveillance programs.

Severe skin reactions have been noted, which may manifest as skin reddening, blisters, or 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. Marked drowsiness is another noted effect.

Patients should be aware that if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults, or if fever worsens or lasts more than 3 days, medical consultation is recommended. The presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache that persists may indicate a serious condition requiring further evaluation.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can significantly impact the outcome in such situations.

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 a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures or humidity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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