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Good Sense Day Time Cold and Flu

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Active ingredients
  • Acetaminophen 325 mg/15 mL
  • Guaifenesin 200 mg/15 mL
  • Dextromethorphan Hydrobromide 10 mg/15 mL
  • Phenylephrine Hydrochloride 5 mg/15 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
November 8, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 325 mg/15 mL
  • Guaifenesin 200 mg/15 mL
  • Dextromethorphan Hydrobromide 10 mg/15 mL
  • Phenylephrine Hydrochloride 5 mg/15 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
November 8, 2024
Manufacturer
L. Perrigo Company
Registration number
M012
NDC root
0113-2299
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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Drug Overview

GOOD SENSE® is a maximum strength, non-drowsy medication designed to provide temporary relief from common cold and flu symptoms. It contains several active ingredients, including acetaminophen (a pain reliever and fever reducer), phenylephrine HCl (a nasal decongestant), dextromethorphan HBr (a cough suppressant), and guaifenesin (an expectorant). Together, these ingredients help alleviate sinus congestion, nasal congestion, minor aches and pains, headaches, sore throats, fevers, and coughs caused by throat and bronchial irritation.

This medication works by reducing swelling in the nasal passages, promoting drainage, and helping to loosen phlegm (mucus) to make coughs more productive. With its honey flavor, GOOD SENSE® aims to make your experience more pleasant while you recover from your cold or flu symptoms.

Uses

You can use this medication to temporarily relieve symptoms associated with the common cold and flu. It helps with sinus congestion and pressure, nasal congestion, minor aches and pains, headaches, sore throats, and fevers. If you're experiencing a cough due to minor throat and bronchial irritation, this medication can also assist in easing that discomfort.

Additionally, it works to reduce swelling in the nasal passages, promotes drainage from the nose and sinuses, and temporarily restores easier breathing through your nose. It also helps loosen phlegm (mucus) and thin bronchial secretions, making it easier to clear out bothersome mucus and making your coughs more productive.

Dosage and Administration

It's important to take this medication exactly as directed to ensure your safety. You should only use the dose cup that comes with the medication to measure your doses. Remember, you should not exceed 4 doses in a 24-hour period.

For adults and children aged 12 years and older, the recommended dose is 30 mL every 4 hours. If your child is between 6 and 12 years old, they should take 15 mL every 4 hours. For children aged 4 to under 6 years, it's best to consult a doctor before giving them this medication. Please do not use this medication for children under 4 years old. Always follow these guidelines to avoid any potential overdose.

What to Avoid

You should avoid using this product if you are currently taking any other medication that contains acetaminophen, whether it's a prescription or over-the-counter drug. If you're unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist. Additionally, do not use this product if you are taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, or Parkinson’s disease, or for two weeks after stopping an MAOI. If you have a history of allergic reactions to this product or any of its ingredients, you should also refrain from using it.

While using this product, it’s important to follow the dosage instructions carefully and not exceed the recommended amount. Misuse or taking more than directed can lead to serious health issues, including dependence (a condition where your body becomes reliant on a substance). Always prioritize your safety and consult a healthcare professional if you have any questions or concerns.

Side Effects

Using this product may lead to some serious side effects. It contains acetaminophen, which can cause severe liver damage if you take more than 4,000 mg in 24 hours or if you consume three or more alcoholic drinks daily while using it. Be cautious if you notice any severe skin reactions, such as redness, blisters, or rash; stop using the product and seek medical help immediately.

You should also consult a doctor if you experience a sore throat that is severe, lasts more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. Other symptoms that require medical attention include nervousness, dizziness, sleeplessness, worsening pain or cough, or if new symptoms develop. If you have certain health conditions, such as liver disease or heart disease, or if you are taking blood thinners like warfarin, it's important to talk to your doctor before using this product. In case of overdose, seek medical help right away, even if you don't notice any symptoms.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 4,000 mg in 24 hours or if a child takes more than 5 doses in the same timeframe. Be cautious if you consume three or more alcoholic drinks daily while using this product, or if you are taking other medications that also contain acetaminophen. Additionally, be aware that acetaminophen may cause serious skin reactions, such as redness, blisters, or rash. If you experience any of these symptoms, stop using the product and seek medical help immediately. If you have a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor promptly.

Before using this product, talk to your doctor if you have liver disease, heart disease, high blood pressure, diabetes, thyroid disease, or if you have a persistent cough with mucus. It's also important to consult a doctor or pharmacist if you are taking the blood thinner warfarin. If you suspect an overdose, seek emergency medical help or contact a Poison Control Center at 1-800-222-1222 right away, even if you don’t notice any symptoms.

You should stop taking this product and call your doctor if you feel nervous, dizzy, or unable to sleep, if your pain or cough worsens or lasts longer than 5 days for children or 7 days for adults, if your fever worsens or lasts more than 3 days, or if you notice any redness or swelling. New symptoms or a returning cough, especially if accompanied by a rash or headache, could indicate a serious condition that requires medical attention.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Quick action is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Remember, an overdose can happen without obvious warning signs, so don’t hesitate to reach out for help. Your safety and health are the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

When giving medication to children, it's important to follow specific guidelines. For children aged 6 to under 12 years, the recommended dose is 15 mL every 4 hours. If your child is between 4 and under 6 years old, you should consult a doctor before administering any medication. It's crucial to avoid using this medication for children under 4 years old.

Be aware that if your child experiences an overdose, seeking quick medical attention is essential, even if there are no immediate signs or symptoms. Additionally, if your child's pain, nasal congestion, or cough worsens or lasts more than 5 days, you should contact a healthcare professional for further advice.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you or how your kidney function might influence the dosage you should take.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If you have liver disease, it’s important to consult your doctor before using this medication. Your healthcare provider can help determine if it’s safe for you and whether any adjustments to your dosage are necessary. Monitoring your liver function is crucial to ensure your safety while taking this medication. Always prioritize open communication with your healthcare team regarding your liver health.

Drug Interactions

It's important to talk to your healthcare provider before using this medication, especially if you are currently taking warfarin, a blood thinner. Mixing these medications can increase your risk of bleeding, so it's crucial to get professional advice.

Additionally, you should avoid this medication if you are taking a prescription monoamine oxidase inhibitor (MAOI), which is used for certain mental health conditions, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your medication includes an MAOI, please consult your doctor or pharmacist for clarification. Always prioritize your safety by discussing any medications or tests with your healthcare provider.

Storage and Handling

To ensure the best performance of your product, store it at room temperature between 20-25°C (68-77°F). It's important not to refrigerate the product, as this can affect its effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any additional safety instructions provided to ensure safe and effective use.

Additional Information

For adults and children aged 12 years and older, the recommended dose is 30 mL every 4 hours. For children aged 6 to under 12 years, the dose is 15 mL every 4 hours. If your child is between 4 and under 6 years old, consult a doctor for the appropriate dosage. Do not use this medication for children under 4 years old.

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this medication. Always keep it out of reach of children. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt attention is crucial for both adults and children, even if no symptoms are present.

FAQ

What is GOOD SENSE® used for?

GOOD SENSE® is used to temporarily relieve common cold and flu symptoms, including sinus congestion, nasal congestion, minor aches and pains, headache, sore throat, fever, and cough.

What are the active ingredients in GOOD SENSE®?

The active ingredients in GOOD SENSE® are Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, and Guaifenesin.

What is the recommended dosage for adults?

Adults and children 12 years and over should take 30 mL every 4 hours.

Can children use GOOD SENSE®?

Children aged 6 to under 12 years can take 15 mL every 4 hours, but for children under 6 years, you should ask a doctor.

What should I do if I suspect an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Are there any warnings associated with GOOD SENSE®?

Yes, you should not exceed 4 doses in 24 hours, and it contains acetaminophen, which can cause severe liver damage if taken in excess.

Is GOOD SENSE® safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using GOOD SENSE®.

What should I do if I experience a severe allergic reaction?

If you experience symptoms like skin reddening, blisters, or rash, stop using GOOD SENSE® and seek medical help immediately.

Can I take GOOD SENSE® with other medications?

Do not use GOOD SENSE® with any other drug containing acetaminophen or if you are taking a prescription monoamine oxidase inhibitor (MAOI).

What flavor does GOOD SENSE® come in?

GOOD SENSE® is available in a honey flavor.

Packaging Info

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

Packaging configurations for Good Sense Day Time Cold and Flu.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

GOOD SENSE® is a maximum strength formulation designed for the relief of symptoms associated with daytime cold and flu. This non-drowsy medication combines multiple active ingredients, including acetaminophen, phenylephrine HCl, dextromethorphan HBr, and guaifenesin, to provide comprehensive relief. It functions as a pain reliever and fever reducer, nasal decongestant, cough suppressant, and expectorant. The product is presented in a liquid dosage form with a honey flavor, and is available in a 12 FL OZ (354 mL) container. This formulation 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, fever, and cough due to minor throat and bronchial irritation.

Additionally, this drug reduces swelling of the nasal passages, promotes nasal and/or sinus drainage, and temporarily restores freer breathing through the nose. It also aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of bothersome mucus from the bronchial passageways and making coughs more productive.

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. The provided dose cup must be utilized for accurate measurement. It is imperative not to exceed 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, consultation with a healthcare professional is advised before administration. The product is contraindicated for use in children under 4 years of age.

Healthcare professionals should monitor patients for adherence to these guidelines to prevent potential 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 there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

  • In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric, or emotional conditions, as well as for Parkinson’s disease. Verification of the presence of an MAOI in prescription medications should be conducted with a healthcare provider.

  • In individuals with a known history of allergic reactions to this product or any of its components.

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, while children should not take more than 5 doses in the same timeframe. The risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if an adult consumes 3 or more alcoholic drinks daily while using this product.

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 advise patients to consult a doctor if they experience a severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

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

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no signs or symptoms are apparent.

Patients should be advised to discontinue use and contact a healthcare provider if they experience any of the following: increased nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 5 days in children or 7 days in adults; fever that worsens or lasts more than 3 days; presence of redness or swelling; occurrence of new symptoms; or a cough that recurs or is accompanied by a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the recommended dosage of acetaminophen. Specifically, adults should not take more than 4,000 mg of acetaminophen in a 24-hour period, and children should not exceed 5 doses within the same timeframe. The risk of liver damage is heightened if the product is taken in conjunction with other medications containing acetaminophen or if the adult consumes three or more alcoholic drinks daily while using this product.

Patients should be aware of the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Additionally, a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting warrants prompt consultation with a healthcare provider.

Common adverse reactions that may necessitate discontinuation of use and consultation with a doctor include nervousness, dizziness, or sleeplessness. Patients should also seek medical advice if pain, nasal congestion, or cough worsens or lasts longer than five days in children or seven days in adults, if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs with a rash or headache that persists.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, diabetes, thyroid disease, or those experiencing a cough with excessive phlegm should consult a doctor prior to use. Additionally, individuals with difficulty urinating due to an enlarged prostate gland or those with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice before using this product.

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

In the event of an overdose, immediate medical attention is critical. Patients or caregivers should contact a Poison Control Center or seek medical help right away, even if no signs or symptoms are apparent, as quick intervention is essential 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 necessitate careful monitoring due to potential interactions that could affect anticoagulation levels.

Additionally, the use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric disorders, or Parkinson’s disease. This contraindication extends for a period of two weeks following the discontinuation of an MAOI. Patients uncertain about whether their prescription includes an MAOI should seek guidance from a healthcare provider or pharmacist before initiating treatment with this product.

Packaging & NDC

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

Packaging configurations for Good Sense Day Time Cold and Flu.
Details

Pediatric Use

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

Healthcare professionals should be aware of the critical need for quick medical attention in the event of an overdose in pediatric patients, even if no signs or symptoms are immediately apparent. Additionally, if pain, nasal congestion, or cough worsens or persists for more than 5 days in children, further evaluation is warranted.

Geriatric Use

There is no specific information available 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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended 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 on 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 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 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. Adjustments to dosage or treatment regimens may be necessary based on the severity of hepatic impairment, and healthcare providers should evaluate the risks and benefits of therapy in these patients.

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 depending 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. Similarly, no data has been provided concerning non-teratogenic effects. Additionally, there is no information available in the nonclinical toxicology section. Furthermore, no details have been reported in the context of 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 immediately and seek medical assistance.

Additionally, there is a warning regarding the risk of overdose. In cases of suspected overdose, it is crucial to obtain medical help or contact a Poison Control Center promptly at 1-800-222-1222. Timely medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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 instructed not to exceed the recommended dosage. They should also be informed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults, patients should stop use and seek medical advice.

It is important to inform patients to stop using the medication and consult a healthcare professional if fever worsens or lasts more than 3 days, if there is any redness or swelling, or if new symptoms develop. Patients should also 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.

Healthcare providers should encourage patients to consult a doctor before using the medication if they have any of the following conditions: liver disease, heart disease, high blood pressure, diabetes, thyroid disease, or if they have a cough accompanied by excessive phlegm. Furthermore, patients with difficulty urinating due to an enlarged prostate gland or those with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, 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 various package configurations, with specific NDC numbers available for identification. 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 storage conditions must be maintained to ensure optimal efficacy and safety.

Additional Clinical Information

Patients aged 12 years and older are advised to administer 30 mL every 4 hours, while those between 6 to under 12 years should take 15 mL every 4 hours. For children aged 4 to under 6 years, consultation with a healthcare provider is recommended, and the product should not be used in children under 4 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is essential 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 crucial for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Good Sense Day Time Cold and Flu, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.