Good Sense Daytime

Description

Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCl are the active ingredients in this formulation, designed for multi-symptom relief associated with cold and flu. Each package contains 8 softgels, providing a combination of pain relief, fever reduction, cough suppression, and nasal decongestion. The product is formulated to be non-drowsy, making it suitable for daytime use. Indications include alleviating symptoms such as headache, fever, sore throat, minor aches and pains, nasal congestion, and cough. This formulation is comparable to the active ingredients found in Vicks® DayQuil® Cold & Flu. The softgels are presented in a size that is convenient for travel.

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, cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, and fever.

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

Dosage and Administration

Patients should take the medication only as directed, adhering to the overdose warning. 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 two softgels taken with water every four hours as needed.

For children aged 4 to under 12 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.

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

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the maximum recommended dosage is 4,000 mg of acetaminophen within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications containing acetaminophen or consuming three or more alcoholic beverages daily while taking this product.

Severe skin reactions have been associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. Should any of these reactions occur, 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 instructed to consult a healthcare provider promptly.

General precautions should be taken for patients with pre-existing conditions. It is advisable to consult a physician before use in individuals with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland. Additionally, patients experiencing a cough with excessive phlegm or a persistent cough related to smoking, asthma, or emphysema should seek medical advice prior to use. Patients taking the anticoagulant warfarin should also consult a healthcare professional or pharmacist before using this product.

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help, even if no symptoms are apparent.

Patients should discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness. 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. Redness, 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 condition.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, 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.

Participants experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

Patients are advised to stop use and contact a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs or is accompanied by a rash or headache that persists. These symptoms may indicate a serious condition.

Before using this product, patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland should consult a healthcare provider. Additionally, those with a cough that produces excessive phlegm or a persistent cough related to smoking, asthma, 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 the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Drug Interactions

Patients should exercise caution when using this product in conjunction with certain medications due to potential interactions.

Anticoagulants Co-administration with warfarin, a blood-thinning agent, may necessitate careful monitoring. Patients are advised to consult with a healthcare professional prior to use to assess the risk of increased bleeding.

Monoamine Oxidase Inhibitors (MAOIs) The use of this product is contraindicated in patients currently taking prescription MAOIs, which are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease. Additionally, it should not be used for at least 2 weeks following the discontinuation of an MAOI. Patients uncertain about their medication's classification should seek guidance from a healthcare provider before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Good Sense Daytime (acetaminophen, dextromethorphan hbr, phenylephrine hcl). 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 not recommended for children under 4 years of age. For adolescents and adults aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in 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 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 should consult a healthcare professional prior to use, particularly if they experience difficulties with urination due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's specific condition.

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 regarding the use of this product, as compromised liver function may affect the metabolism and clearance of the medication. Monitoring of liver function may be necessary to ensure safety and efficacy in this patient 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

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions, which can manifest as skin reddening. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance. These reports have been received voluntarily and through surveillance programs, highlighting the importance of monitoring for such adverse events in the postmarketing setting.

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 be encouraged to consult with a doctor or pharmacist.

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 an MAOI within the past two weeks. Patients should be advised to verify with a healthcare professional if they are unsure whether their prescription includes an MAOI.

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

Healthcare providers should also inform patients to stop using the product and seek medical advice if pain, nasal congestion, or cough worsens or persists for more than seven days. Additionally, patients should be advised to consult a doctor if fever worsens or lasts longer than three days, or if they notice any redness or swelling. New symptoms that arise should prompt a discussion with a healthcare provider.

Patients should be made aware that if a cough returns or occurs alongside a rash or persistent headache, they should seek medical attention, as these may indicate a serious condition. It is essential to remind patients to adhere strictly to the recommended dosage and not exceed the directed amount.

Before using this product, patients should be encouraged to consult a doctor 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. Furthermore, patients with a cough that produces excessive phlegm or a persistent cough associated with smoking, asthma, or emphysema should also seek medical advice prior to use. Lastly, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It should be stored at room temperature, within the range of 20°C to 25°C (68°F to 77°F).

To ensure the integrity of the product, it must be protected from light and the container should remain tightly closed when not in use. It is important to note that the product should be discarded after opening to maintain safety and efficacy.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 softgels taken with water every 4 hours. For children aged 4 to under 12 years, it is advised to consult a doctor before use, while the medication is not recommended for children under 4 years of age.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, patients should be informed of the overdose warning, emphasizing the importance of obtaining medical help or contacting a Poison Control Center (1-800-222-1222) immediately in the event of an overdose, as prompt medical attention is crucial for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)