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Foster and Thrive Daytime Severe Cold and Flu Relief

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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 2026
Label revision date
March 6, 2026
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 2026
Label revision date
March 6, 2026
Manufacturer
Sportpharm LLC
Registration number
M012
NDC root
85766-179
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 and sinus congestion, cough due to minor throat and bronchial irritation, as well as minor aches, pains, headaches, fever, and sore throat.

Additionally, it works by reducing swelling in the nasal passages, promoting drainage, and loosening phlegm (mucus) to make coughs more productive. This means you can breathe more freely and feel more comfortable while dealing with cold or flu symptoms.

Uses

This medication is designed to temporarily relieve a variety of common cold and flu symptoms. If you're dealing with nasal or sinus congestion and pressure, this product can help reduce swelling in your nasal passages, making it easier for you to breathe. It also addresses minor aches and pains, headaches, fever, and sore throats.

In addition to easing these discomforts, it promotes drainage in your nasal and sinus areas and helps loosen phlegm (mucus). This can make your coughs more productive by clearing out bothersome mucus from your bronchial passageways. Overall, it aims to provide you with relief so you can feel more comfortable while you recover.

Dosage and Administration

It's important to take this medication exactly as directed to avoid any risks, including overdose. For adults and children aged 12 years and older, you should take 2 caplets with a full glass of water every 4 hours, but make sure not to exceed 8 caplets in a 24-hour period.

If your child is between 4 and 12 years old, it's best to consult a doctor before giving them this medication. For children under 4 years old, you should not use this medication at all. Always follow these guidelines to ensure safe and effective use.

What to Avoid

You should avoid using this medication if you are currently taking any other drug that contains acetaminophen, whether it's a prescription or over-the-counter product. If you're unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist. Additionally, do not take this medication if you are on a prescription monoamine oxidase inhibitor (MAOI), which is used for certain mental health conditions or Parkinson’s disease, or for two weeks after stopping an MAOI. If you are uncertain about your medications, it's important to ask a healthcare professional. Lastly, do not use this product if you have ever experienced an allergic reaction to it or any of its ingredients.

Side Effects

You should be aware of some important warnings and potential side effects when using this product. It contains acetaminophen, which can cause severe liver damage if you exceed 4,000 mg in 24 hours, take it with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using it. Additionally, acetaminophen may lead to serious skin reactions, such as skin reddening, blisters, or rash. If you experience any of these symptoms, 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 have trouble sleeping, if your pain or cough worsens or lasts more than seven days, or if you develop new symptoms. Always talk to your doctor before using this product if you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or other specific health concerns.

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 issues, 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, it's important to talk to your doctor if you have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to an enlarged prostate, or a persistent cough. If you are taking the blood thinner warfarin, consult your doctor or pharmacist before use. If you suspect an overdose, seek emergency medical help or contact a Poison Control Center right away at 1-800-222-1222, 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, nasal congestion, or cough worsens or lasts more than seven days; if your fever worsens or lasts more than three days; if you notice redness or swelling; if new symptoms develop; or if your cough returns with a rash or headache that persists. These could indicate a more 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 lead to serious health issues, so don’t wait for symptoms to appear before getting help. Always prioritize safety and reach out for assistance right away.

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 have a child aged 4 to under 12 years, it's important to consult with a doctor before using this medication. For children under 4 years old, you should not use this product at all. For adults and children aged 12 years and older, the recommended dosage is 2 caplets with water every 4 hours, but be careful not to exceed 8 caplets in a 24-hour period.

In case of an overdose, it's crucial to seek medical help immediately, even if your child shows no signs or symptoms. Always prioritize safety and follow these guidelines to ensure the well-being of your child.

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 consult your doctor before using this medication, especially if you experience difficulty urinating due to an enlarged prostate gland. Your healthcare provider can help determine if this medication is safe for you and may suggest adjustments to your dosage or monitoring based on your kidney function. Always prioritize open communication with your doctor regarding any concerns related to your kidney health.

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 your doctor 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 have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any tests you are undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain its 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.

Additional Information

No further information is available.

FAQ

What symptoms does this drug relieve?

This drug temporarily relieves common cold and flu symptoms, including nasal congestion, sinus congestion and pressure, cough, minor aches and pains, headache, fever, and sore throat.

How does this drug help with breathing?

It reduces swelling of nasal passages, temporarily restores freer breathing through the nose, and promotes nasal and sinus drainage.

What should I do if I experience severe skin reactions?

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

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

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

Can children under 4 years use this drug?

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

What should I do in case of overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately, as quick medical attention is critical.

Are there any warnings regarding liver damage?

Yes, severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours, use with other acetaminophen-containing drugs, or consume 3 or more alcoholic drinks daily while using this product.

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

Stop using the drug and consult a doctor if your pain, nasal congestion, or cough worsens or lasts more than 7 days, or if new symptoms develop.

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

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

What should I do if I have a history of liver disease?

Ask a doctor before using this product if you have liver disease or any other serious health conditions.

Packaging Info

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

Packaging configurations for Foster and Thrive Daytime Severe Cold and Flu Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

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: nasal congestion, sinus congestion and pressure, cough due to minor throat and bronchial irritation, minor aches and pains, headache, fever, sore throat, and swelling of nasal passages.

Additionally, this drug promotes the restoration of freer breathing through the nose, facilitates nasal and/or sinus drainage, and aids in loosening phlegm (mucus) and thinning bronchial secretions. This action helps to clear 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 take the medication only as directed, adhering to the overdose warning. The maximum dosage should not exceed 8 caplets within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 2 caplets 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.

This medication is not intended for use in children under 4 years of age.

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 prescribed medications should be conducted with a healthcare professional.

  • In individuals with a known history of allergic reactions to this product or any of its components, to prevent potential severe allergic responses.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is essential to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be instructed to consult a physician promptly.

General Precautions Healthcare professionals should advise patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Additionally, patients with persistent or chronic coughs, such as those related to smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. It is crucial to inquire about concurrent use of warfarin, a blood-thinning medication, as this may necessitate additional monitoring.

Emergency Medical Help In the event of an overdose, immediate medical attention is required. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222. Prompt intervention is critical for both adults and children, even if no symptoms are initially apparent.

Discontinuation and Consultation Patients should be advised to stop taking the product and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, worsening pain, nasal congestion, or cough lasting more than seven days, fever persisting beyond three days, the presence of redness or swelling, the emergence of new symptoms, or a cough that recurs with a rash or headache should prompt immediate medical evaluation, as these may indicate a serious underlying condition.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should consult a doctor if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. Other symptoms that warrant medical consultation include nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or cough lasting more than seven days, as well as fever that worsens or lasts more than three days. Redness or swelling, the emergence of new symptoms, or a cough that recurs or occurs with a rash or headache that lasts may indicate a serious condition.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland should seek medical advice before using this product. Furthermore, individuals with a persistent or chronic cough, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, should also consult a healthcare professional prior to use. It is important for patients taking the blood-thinning medication warfarin to discuss their use of this product with a doctor or pharmacist.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Foster and Thrive Daytime Severe Cold and Flu Relief.
Details

Pediatric Use

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

In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, 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 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 degree of impairment.

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 daily while using this product is not recommended, as it may exacerbate the risk of liver damage.

Additionally, patients with a known history of liver disease are advised to consult a healthcare professional prior to using this product. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

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 procedures should include the following steps:

  1. Assessment of Symptoms: Continuous monitoring for any potential symptoms of overdose is necessary, as they may not be immediately apparent.

  2. Supportive Care: Provide supportive care as needed, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

  3. Decontamination: If appropriate and within the timeframe, consider decontamination measures such as activated charcoal, following established protocols.

  4. Specific Antidotes: If a specific antidote is available for the substance involved, it should be administered as per established guidelines.

  5. Hospitalization: Depending on the severity of the overdose and the patient's condition, hospitalization may be required for further observation and treatment.

It is essential for healthcare professionals to remain vigilant and act swiftly in the case of an overdose to mitigate potential complications and ensure the best possible outcome for the patient.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

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

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Foster and Thrive Daytime Severe Cold and Flu Relief, 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 Foster and Thrive Daytime Severe Cold and Flu Relief, 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.