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Kroger Daytime Cold and Flu Softgel

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Active ingredients
  • Acetaminophen 325 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
December 13, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 325 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Capsule, Liquid Filled
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 2022
Label revision date
December 13, 2024
Manufacturer
The Kroger Company
Registration number
M012
NDC root
30142-087
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to temporarily relieve symptoms associated with the common cold and flu. It can help alleviate nasal congestion, soothe a cough caused by minor throat and bronchial irritation, and ease discomfort from a sore throat. Additionally, it addresses headaches, minor aches and pains, and fever, providing you with some comfort during your illness.

By targeting these common symptoms, this medication aims to help you feel better while your body fights off the cold or flu. Always consult with a healthcare professional for personalized advice and treatment options.

Uses

If you're dealing with the discomfort of a common cold or flu, this medication can help provide temporary relief from several bothersome symptoms. You can expect it to ease nasal congestion, soothe a sore throat, and reduce coughing caused by minor irritation in your throat and bronchial tubes. Additionally, it can help alleviate headaches, minor aches and pains, and even lower a fever.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause harm to a developing fetus. It's designed to help you feel better while you recover from your illness.

Dosage and Administration

It's important to take this medication exactly as directed to avoid any risks, including overdose. You should not take more than four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is to take two softgels with water every four hours. If you have a child between the ages of 4 and 12, it's best to consult a doctor before giving them this medication. For children under 4 years old, do not use this medication at all. Always follow these guidelines to ensure safe and effective use.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you can use it without concerns about these particular issues. However, always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

You should be aware of some important warnings and potential side effects when using this product. Taking more than four doses in 24 hours, using it with other medications that contain acetaminophen, or consuming three or more alcoholic drinks daily can lead to severe liver damage. Additionally, acetaminophen may cause serious skin reactions, which can include symptoms like skin reddening, blisters, or rash. If you experience any skin reactions, stop using the product and seek medical help immediately.

It's also important to consult a doctor if you have a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting. You should stop using the product and contact a healthcare professional if you feel nervous, dizzy, or unable to sleep, if your pain or cough worsens or lasts more than seven days, or if you develop new symptoms. Remember, taking more than the recommended dose can lead to serious health issues, so if you suspect an overdose, seek medical assistance right away.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 4 doses in 24 hours, use it with other acetaminophen-containing medications, or consume 3 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 reaction, stop using the product and seek medical help immediately. Additionally, if you have a severe sore throat that lasts more than 2 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 any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or trouble urinating due to an enlarged prostate. It's also important to ask a doctor or pharmacist if you are taking the blood-thinning medication warfarin or if you are unsure whether any other medications you are taking contain acetaminophen. Always follow the dosing instructions carefully and do not exceed the recommended amount.

If you experience nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or cough lasting more than 7 days, or if your fever worsens or lasts more than 3 days, stop using the product and consult your doctor. Seek emergency medical help immediately in case of overdose, or contact a Poison Control Center at 1-800-222-1222, as quick medical attention is crucial.

Overdose

Taking more of this medication than directed can lead to serious health issues. If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick action is crucial, especially for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Remember, being proactive can make a significant difference in ensuring safety and health. Always err on the side of caution and reach out for help if you have any concerns about overdose.

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

If you are considering this medication for your child, it's important to know the guidelines for different age groups. For children aged 4 to under 12 years, you should consult with a doctor before using it. This ensures that the medication is appropriate and safe for your child's specific needs.

For children under 4 years old, it is advised not to use this medication at all. Always prioritize your child's safety by following these recommendations and seeking professional advice when necessary.

Geriatric Use

While there is no specific information about the use of Kroger Daytime Cold and Flu Softgel in older adults, it's important to approach any medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. They can help ensure that it is safe and appropriate for your individual health needs, especially if you have any existing health conditions or are taking other medications. Always prioritize your health and well-being by seeking guidance tailored to your situation.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using products that contain acetaminophen. Taking more than 4 doses in a 24-hour period can lead to severe liver damage, which is the maximum daily amount recommended. Additionally, avoid using other medications that also contain acetaminophen, and limit alcohol consumption to fewer than 3 drinks per day while using this product, as these factors can increase the risk of liver damage.

Before using this product, please consult your doctor if you have liver disease. They can provide guidance tailored to your specific health needs and help ensure your safety while using medications.

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 medications that contain acetaminophen, whether they are prescription or over-the-counter. Additionally, if you are currently taking a monoamine oxidase inhibitor (MAOI)—a type of medication often prescribed for depression or certain psychiatric conditions—or have taken one in the last 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 room temperature, ideally between 20-25 °C (68-77 °F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You can take this medication orally. For adults and children aged 12 years and older, the recommended dose is 2 softgels taken with water every 4 hours. If your child is between 4 and 12 years old, consult a doctor for the appropriate dosage. This medication should not be used in children under 4 years old.

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this medication. Additionally, if you're concerned about the potential for medicine abuse, especially among teens, you can find helpful resources at www.StopMedicineAbuse.org.

FAQ

What symptoms does this drug temporarily relieve?

This drug temporarily relieves common cold and flu symptoms, including nasal congestion, cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, and fever.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over should take 2 softgels with water every 4 hours, not exceeding 4 doses in 24 hours.

Can children under 4 years use this medication?

No, children under 4 years should not use this medication.

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

If you experience severe skin reactions such as reddening, blisters, or rash, stop use and seek medical help immediately.

What should I do in case of an overdose?

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

Is it safe to use this drug if I am pregnant or breastfeeding?

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

What should I do if my symptoms worsen or new symptoms occur?

Stop use and consult a doctor if your symptoms worsen, last more than the recommended duration, or if new symptoms occur.

Are there any specific warnings regarding liver health?

Yes, this product contains acetaminophen, and severe liver damage may occur if you take more than 4 doses in 24 hours, with other acetaminophen-containing drugs, or consume 3 or more alcoholic drinks daily while using this product.

Packaging Info

Below are the non-prescription pack sizes of Kroger Daytime Cold and Flu Softgel (acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Kroger Daytime Cold and Flu Softgel.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

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 4 doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 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 recommended for use in children under 4 years of age.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4 doses within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic beverages daily while using this product.

Allergy Alert Acetaminophen may 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.

Sore Throat Warning Healthcare professionals should advise patients to consult a doctor if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

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 other medications, patients should consult a doctor or pharmacist. Additionally, this product is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Patients should verify with a healthcare provider if they are unsure whether their prescription includes an MAOI.

Pre-Use Consultation Patients should seek medical advice before using this product if they have any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, difficulty urinating due to an enlarged prostate gland, a cough associated with excessive phlegm, or a persistent or chronic cough related to smoking, asthma, or emphysema. Furthermore, it is advisable to consult a doctor or pharmacist if the patient is taking the anticoagulant warfarin.

Usage Instructions Patients must adhere strictly to the recommended dosage and should not exceed the directed amount.

Discontinuation of Use Patients should stop using this product and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 7 days; if fever worsens or lasts more than 3 days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition.

Emergency Assistance In the event of an overdose, immediate medical attention is crucial. Patients should 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. Quick intervention is essential for both adults and children.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe liver damage, which may occur if patients exceed the maximum daily dosage of 4 doses within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Additionally, patients should be aware of the potential for severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative that patients discontinue use and seek medical assistance immediately.

Patients are advised to consult a healthcare professional if they experience a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. Furthermore, patients should stop use and seek medical advice if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than 7 days; if fever worsens or lasts more than 3 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 underlying condition.

Patients should also be cautioned about the risks associated with overdose. Taking more than the directed dosage can lead to serious health complications. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

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 two 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 safe use and to mitigate the risk of altered anticoagulant effects.

Packaging & NDC

Below are the non-prescription pack sizes of Kroger Daytime Cold and Flu Softgel (acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Kroger Daytime Cold and Flu Softgel.
Details

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional prior to use. The product is not recommended for children under 4 years of age.

Geriatric Use

There is no specific information regarding the use of Kroger Daytime Cold and Flu Softgel 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. Monitoring for potential adverse effects is advisable, given the lack of targeted data for 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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 that patients do not exceed 4 doses within a 24-hour period, as this represents the maximum daily amount for this product. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks daily while using this product is not recommended, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with hepatic impairment to ensure safety and efficacy during treatment.

Overdosage

In the event of an overdose, it is imperative to recognize that exceeding the recommended dosage can lead to serious health complications. Healthcare professionals should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 without delay.

Quick medical intervention is crucial, particularly for adults and children, even in the absence of noticeable signs or symptoms. It is essential to monitor the patient closely and provide appropriate care based on the clinical presentation and severity of 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 reports of severe skin reactions associated with acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of adhering to the recommended dosage, as taking more than directed can lead to serious health problems. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent.

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 room temperature, maintaining a temperature range between 20-25 °C (68-77 °F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 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, information regarding the potential for medicine abuse, particularly among teens, can be found at www.StopMedicineAbuse.org. There are no further details available regarding laboratory tests or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Kroger Daytime Cold and Flu Softgel, 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 Kroger Daytime Cold and Flu Softgel, 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.