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Daytime Cold and Flu Severe, Caseys 4good, Daytime Cold and Flu Severe, Casey...

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Active ingredients
  • Acetaminophen 325 mg
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Tablet, Film Coated
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 14, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 325 mg
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Tablet, Film Coated
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 14, 2023
Manufacturer
Lil' Drug Store Products, Inc.
Registration number
M012
NDC roots
66715-6304, 66715-6315
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Daytime Cold & Flu Severe is a medication designed to temporarily relieve symptoms associated with the common cold and flu. It contains several active ingredients that work together to help you feel better. Acetaminophen acts as a pain reliever and fever reducer, while phenylephrine HCl serves as a nasal decongestant to reduce swelling in the nasal passages, making it easier to breathe. Dextromethorphan HBr is included as a cough suppressant, and guaifenesin helps loosen mucus in the airways, promoting more productive coughs.

This medication can help alleviate minor aches and pains, sore throat, sinus congestion, headache, fever, and cough due to throat and bronchial irritation. By addressing these symptoms, Daytime Cold & Flu Severe aims to provide you with relief so you can feel more comfortable during your recovery.

Uses

This medication is designed to temporarily relieve a variety of common cold and flu symptoms that you might experience. If you're dealing with minor aches and pains, sinus congestion, or a sore throat, this product can help ease those discomforts. It also addresses fever, headaches, and nasal congestion, making it easier for you to breathe.

In addition to alleviating these symptoms, it promotes drainage in your nasal passages and sinuses, helping to clear out mucus. This can be particularly beneficial if you're experiencing a cough due to minor throat and bronchial irritation, as it helps loosen phlegm and makes your coughs more productive. Overall, this medication aims to provide you with relief so you can feel more comfortable while you recover.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. For adults and children aged 12 years and older, you should take 2 caplets with a glass of water every 4 hours as needed. However, make sure not to exceed 8 caplets in a 24-hour period.

If you are considering this medication for a child under 12 years old, it's best to consult a doctor first to determine the appropriate dosage. Always remember to take only the directed amount to avoid any potential risks.

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 about a medication's ingredients, it's best to consult with your doctor or pharmacist. Additionally, do not use this product if you are taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson’s disease, or if you have stopped taking an MAOI within the last two weeks. Again, if you're uncertain about your medications, please ask a healthcare professional.

It's also important not to use this product if you have ever experienced an allergic reaction to it or any of its ingredients. Taking these precautions can help ensure your safety and well-being.

Side Effects

Taking this medication can lead to some serious side effects, so it's important to be aware of them. You should avoid exceeding 4,000 mg of acetaminophen in a 24-hour period, taking it with other acetaminophen-containing products, or consuming three or more alcoholic drinks daily while using this product, as these can cause severe liver damage.

Additionally, be cautious of potential allergic reactions, which may include severe skin issues like reddening, blisters, or rashes. If you experience any of these skin reactions, stop using the medication and seek medical help immediately. You should also consult your doctor if you notice nervousness, dizziness, or sleeplessness, if your pain or cough worsens or lasts more than a week, if your fever persists for more than three days, or if you develop new symptoms. These could indicate a more serious condition.

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, use it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as redness, blisters, or rashes. If you experience any skin reactions, 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, do not take it with any other medications containing acetaminophen, and avoid it if you are currently on a prescription monoamine oxidase inhibitor (MAOI) or have had an allergic reaction to it in the past. If you have liver disease, thyroid disease, diabetes, heart disease, high blood pressure, or other specific health conditions, ask your doctor before use. If you are taking the blood thinner warfarin, consult your doctor or pharmacist as well. Always follow the recommended dosage and do not exceed it.

In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately, as prompt attention is crucial. Stop using the product and call your doctor if you experience nervousness, dizziness, or sleeplessness, if your pain or cough worsens or lasts more than seven days, if your fever worsens or lasts more than three days, or if you notice any new symptoms. These could indicate a more serious condition.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t wait—get help right away. Remember, acting quickly can make a significant difference in ensuring safety and health.

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 this medication. They can provide guidance on any potential risks and help ensure the safety of both you and your baby. Always prioritize open communication with your healthcare provider regarding your breastfeeding journey.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this medication. For adults and children aged 12 and older, the recommended dosage is to take 2 caplets with water every 4 hours, but be sure not to exceed 8 caplets in a 24-hour period. Always follow these guidelines to ensure safe use for your family.

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 if your kidneys are not functioning properly.

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 problems, it's important to be cautious when using products that contain acetaminophen. Taking more than 4,000 mg of acetaminophen in a 24-hour period, using it alongside other medications that also contain acetaminophen, or consuming three or more alcoholic drinks daily while using this product can lead to severe liver damage.

Before using this product, you should consult with your doctor, especially if you have liver disease. They can provide guidance on safe usage and any necessary adjustments to your dosage. Your health and safety are the top priority, so don’t hesitate to seek professional advice.

Drug Interactions

It's important to be cautious when taking this medication, especially regarding potential interactions with other drugs. You should avoid using it alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. Additionally, if you are currently taking a prescription monoamine oxidase inhibitor (MAOI)—a type of medication often used for depression or certain other conditions—or have taken one in the past two weeks, you should not use this medication.

Before starting this medication, it's also wise to consult with your doctor or pharmacist if you are taking warfarin, a blood-thinning medication. Discussing all your current medications and health conditions with your healthcare provider can help ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best performance of your product, store it at a temperature of 25°C (77°F). It can safely be kept within a range of 15°-30°C (59°-86°F) for short periods. Always check the end flap for the expiration date and lot number to confirm its usability.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Proper storage and careful handling are essential for safety and effectiveness, so please follow these guidelines closely.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Always keep this medication out of reach of children. In the event of an overdose, seek medical help or contact a Poison Control Center immediately, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

FAQ

What is Daytime Cold & Flu Severe used for?

Daytime Cold & Flu Severe temporarily relieves common cold and flu symptoms such as minor aches and pains, sinus congestion, sore throat, fever, headache, nasal congestion, and cough.

What are the active ingredients in Daytime Cold & Flu Severe?

The active ingredients include acetaminophen (pain reliever/fever reducer), phenylephrine HCl (nasal decongestant), dextromethorphan HBr (cough suppressant), and guaifenesin (expectorant).

How should I take Daytime Cold & Flu Severe?

Adults and children 12 years and over should take 2 caplets with water every 4 hours, not exceeding 8 caplets in 24 hours. Children under 12 years should ask a doctor.

Are there any warnings associated with Daytime Cold & Flu Severe?

Yes, do not use with any other drug containing acetaminophen, if you are taking a prescription monoamine oxidase inhibitor (MAOI), or if you have had an allergic reaction to this product.

What should I do if I experience severe skin reactions?

If you experience symptoms like skin reddening, blisters, or rash, stop using the product and seek medical help immediately.

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center right away, as prompt medical attention is critical.

Is it safe to use Daytime Cold & Flu Severe during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this product.

What are the storage instructions for Daytime Cold & Flu Severe?

Store at 25°C (77°F), with permitted excursions between 15°-30°C (59°-86°F).

Packaging Info

Below are the non-prescription pack sizes of Daytime Cold and Flu Severe, Caseys 4good, Daytime Cold and Flu Severe, Caseys 4goog (acetaminophen, phenylephrine, dextromethorphan hbr, guaifenesin tablet, film coated). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Daytime Cold and Flu Severe, Caseys 4good, Daytime Cold and Flu Severe, Caseys 4goog.
Details

Drug Information (PDF)

This file contains official product information for Daytime Cold and Flu Severe, Caseys 4good, Daytime Cold and Flu Severe, Caseys 4goog, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Daytime Cold & Flu Severe is presented in a dosage form of 6 caplets. The formulation includes the following active ingredients: acetaminophen, which serves as a pain reliever and fever reducer; phenylephrine HCl, a nasal decongestant; dextromethorphan HBr, a cough suppressant; and guaifenesin, an expectorant. This combination is designed to relieve a range of symptoms associated with cold and flu, including headache, cough, fever, minor aches and pains, sore throat, chest congestion, sinus pressure, and nasal congestion.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates minor aches and pains, sinus congestion and pressure, sore throat, fever, headache, nasal congestion, and cough due to minor throat and bronchial irritation.

Additionally, this drug reduces swelling of the nasal passages, temporarily restores freer breathing through the nose, promotes nasal and/or sinus drainage, and helps loosen phlegm (mucus) while thinning bronchial secretions. This action aids in clearing the bronchial passageways of bothersome mucus, thereby making coughs more productive.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the prescribed dosage is 2 caplets taken with water every 4 hours, not to exceed 8 caplets within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

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 there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

  • Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should verify with a healthcare professional if they are unsure whether their prescription includes an MAOI.

  • History of allergic reactions to this product or any of its ingredients, as this may lead to severe adverse reactions.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Severe skin reactions may occur in individuals allergic to acetaminophen. Symptoms of such reactions include skin reddening, blisters, and rash. If any of these symptoms manifest, the individual should 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, it is imperative to consult a healthcare professional promptly.

Contraindications This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a doctor or pharmacist is advised. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. Those with a known allergy to this product or any of its ingredients should also refrain from use.

Precautions Healthcare professionals should advise patients to consult a doctor before using this product if they have any of the following conditions: liver disease, thyroid disease, diabetes, heart disease, high blood pressure, difficulty urinating due to prostate enlargement, 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 prior to use. Furthermore, individuals taking the anticoagulant warfarin should consult a healthcare provider or pharmacist before using this product.

Dosage and Monitoring Patients must adhere to the recommended dosage and should not exceed it. In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

When to Seek Medical Attention Patients should discontinue use and contact a healthcare professional if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 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 lasting more than a short duration. These symptoms may indicate a serious underlying condition that requires further evaluation.

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. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients are advised to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists for more than seven days, 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 or is accompanied by a rash or headache that lasts may indicate a serious condition, warranting prompt medical evaluation.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be used for at least 2 weeks following the discontinuation of an MAOI to avoid serious interactions.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safety and efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Cold and Flu Severe, Caseys 4good, Daytime Cold and Flu Severe, Caseys 4goog (acetaminophen, phenylephrine, dextromethorphan hbr, guaifenesin tablet, film coated). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Daytime Cold and Flu Severe, Caseys 4good, Daytime Cold and Flu Severe, Caseys 4goog.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours, with a maximum of 8 caplets in a 24-hour period.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 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 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

  • Patients should not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period.

  • Concurrent use with other medications containing acetaminophen is contraindicated, as this may lead to unintentional overdose and increased risk of liver injury.

  • Consumption of three or more alcoholic drinks per day while using this product is not recommended, as it may exacerbate the potential for liver damage.

Additionally, patients with a known history of liver disease should consult a healthcare professional prior to using this product to ensure safety and appropriateness of treatment. Regular monitoring of liver function may be warranted in patients with compromised liver function to detect any signs of hepatotoxicity early.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate medical care as needed.

Nonclinical Toxicology

No teratogenic effects were identified in the studies conducted. Additionally, there were no reported non-teratogenic effects. The available data does not provide any details regarding nonclinical toxicology. Furthermore, there are no findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified reports of severe skin reactions associated with acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, users are advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of safety in the home environment.

In the event of an overdose, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. They should stress that prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can significantly impact the outcome in cases of accidental overdose.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper tracking and usage. Special handling requirements should be adhered to in order to maintain the integrity of the product during storage.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is crucial to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Daytime Cold and Flu Severe, Caseys 4good, Daytime Cold and Flu Severe, Caseys 4goog, 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 Daytime Cold and Flu Severe, Caseys 4good, Daytime Cold and Flu Severe, Caseys 4goog, 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.