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Foster and Thrive Chest Congestion Relief

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Active ingredient
Guaifenesin 400 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet
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
December 23, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 400 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet
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
December 23, 2024
Manufacturer
Strategic Sourcing Services LLC
Registration number
M012
NDC root
70677-1054
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 help loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to clear mucus from your airways. By doing so, it helps make your coughs more productive, allowing you to expel bothersome mucus more effectively. This can be particularly helpful if you're dealing with respiratory issues that involve congestion.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it aids in clearing out bothersome mucus from your bronchial passageways.

Additionally, it makes your coughs more productive, meaning that when you do cough, it helps you expel mucus more effectively. This can be particularly helpful if you're dealing with respiratory issues that involve congestion.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 1 tablet every 4 hours as needed for relief. For children aged 6 to 10 years, the recommended dose is 1/2 tablet every 4 hours as needed. However, if your child is under 6 years old, it’s important to consult a doctor before giving them this medication.

Make sure not to exceed 6 doses in a 24-hour period, unless your doctor advises otherwise. This helps ensure safe and effective use of the medication. Always follow these guidelines to manage your or your child's symptoms effectively.

What to Avoid

It's important to be mindful of when to stop using this medication. If you experience symptoms like fever, rash, or a persistent headache, you should stop taking it and consult your doctor. Additionally, if your cough lasts more than a week or keeps coming back, it's best to stop using the medication and seek medical advice.

While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, always prioritize your health and safety by following these guidelines.

Side Effects

If you are considering using this medication, it's important to consult your doctor first if you have a persistent or chronic cough, especially if it’s related to smoking, asthma, bronchitis, or emphysema. Additionally, if your cough comes with excessive mucus, you should also seek medical advice.

You should stop using the medication and contact your doctor if you experience symptoms like fever, rash, or a persistent headache. If your cough lasts more than a week or keeps coming back, it may indicate a more serious health issue that needs attention.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have a persistent or chronic cough, especially if it's related to smoking, asthma, bronchitis, or emphysema. Additionally, if your cough comes with excessive phlegm (mucus), you should also seek medical advice.

To ensure safety, keep this medication out of reach of children. In the event of an overdose, seek medical help or contact a Poison Control Center right away.

You should stop taking this medication and call your doctor if you experience symptoms like fever, rash, or a persistent headache. Also, if your cough lasts more than a week or keeps coming back, it's crucial to consult your doctor, as this could indicate a more serious health issue.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

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 this medication to children, it's important to follow specific guidelines based on their age. For adults and children aged 12 and older, the recommended dose is 1 tablet every 4 hours as needed. If your child is between 6 and 10 years old, they should take 1/2 tablet every 4 hours as needed.

For children under 6 years of age, you should consult a doctor before administering the medication. Regardless of age, do not exceed 6 doses in a 24-hour period unless directed by a healthcare professional. Always ensure you are following these guidelines to keep your child safe.

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 considering this medication, it’s important to consult with a healthcare provider. 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 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.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

Hepatic Impairment

If you have liver 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 standard recommendations for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that, based on the available information, this medication does not have known conflicts with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get personalized advice tailored to your health needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15°-30°C (59°-86°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands or gloves to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components. Taking these precautions will help you use the product safely and effectively.

Additional Information

You can take this medication orally. For adults and children aged 12 and over, the recommended dose is 1 tablet every 4 hours as needed. If you are giving it to children aged 6 to 10, they should take 1/2 tablet every 4 hours as needed. For children under 6 years old, it's important to consult a doctor before use. Remember not to exceed 6 doses in a 24-hour period unless directed by a healthcare professional.

FAQ

What does this drug do?

This drug helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive.

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

Adults and children 12 years of age and over should take 1 tablet every 4 hours as needed.

What is the dosage for children aged 6 to 10?

Children aged 6 to 10 should take 1/2 tablet every 4 hours as needed.

What should I do if my child is under 6 years old?

Consult a doctor before giving this drug to children under 6 years of age.

Are there any dosage limits I should be aware of?

Do not exceed 6 doses in a 24-hour period or as directed by a doctor.

What should I do if I experience a persistent cough?

Stop use and ask a doctor if your cough persists for more than 1 week or tends to recur.

What are the warnings associated with this drug?

Ask a doctor before use if you have a persistent cough or if your cough is accompanied by excessive phlegm.

What should I do if symptoms are accompanied by fever or rash?

Stop use and ask a doctor if symptoms are accompanied by fever, rash, or persistent headache.

Is this drug safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

How should I store this drug?

Store at 15°-30°C (59°-86°F).

Packaging Info

Below are the non-prescription pack sizes of Foster and Thrive Chest Congestion Relief (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Foster and Thrive Chest Congestion Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. It is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the management of conditions associated with excessive mucus production in the respiratory tract. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of bothersome mucus from the bronchial passageways. Additionally, this medication aids in making coughs more productive, thereby improving respiratory function.

Limitations of Use: This drug is intended for use in patients experiencing symptoms related to mucus accumulation and is not a substitute for other therapeutic interventions in more severe respiratory conditions.

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 1 tablet every 4 hours as needed. For children aged 6 to 10 years, the recommended dosage is 1/2 tablet every 4 hours as needed. It is essential that children under 6 years of age consult a doctor prior to administration.

Healthcare professionals should advise patients not to exceed 6 doses within a 24-hour period, unless otherwise directed by a physician.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional if symptoms are accompanied by fever, rash, or persistent headache. Additionally, if a cough persists for more than one week or tends to recur, medical advice should be sought.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have a persistent or chronic cough, particularly in cases associated with smoking, asthma, bronchitis, or emphysema. Additionally, individuals should seek medical advice if their cough is accompanied by excessive phlegm (mucus).

It is imperative to keep this medication out of the reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Patients are advised to discontinue use and contact their healthcare provider if they experience any of the following: symptoms accompanied by fever, rash, or a persistent headache; a cough that persists for more than one week; or a cough that tends to recur. A persistent cough may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients should be advised to consult a healthcare professional prior to use if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, bronchitis, or emphysema. Additionally, individuals should seek medical advice if their cough is accompanied by excessive phlegm (mucus).

It is important for patients to discontinue use and contact a healthcare provider if symptoms are accompanied by fever, rash, or a persistent headache. Furthermore, if a cough persists for more than one week or tends to recur, patients should be aware that this may indicate a serious underlying condition.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Foster and Thrive Chest Congestion Relief (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Foster and Thrive Chest Congestion Relief.
Details

Pediatric Use

Pediatric patients aged 12 years and older may take 1 tablet every 4 hours as needed, with a maximum of 6 doses in a 24-hour period or as directed by a healthcare professional. For children aged 6 to 10 years, the recommended dosage is 1/2 tablet every 4 hours as needed, also not to exceed 6 doses in a 24-hour period or as directed.

For children under 6 years of age, consultation with a doctor is advised prior to use. Care should be taken to adhere to the recommended dosing guidelines to ensure safety and efficacy in pediatric populations.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as 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. 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 no specific data available regarding the excretion of this medication in 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 have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, even if they are not explicitly detailed in the available literature. Symptoms of overdose can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, the following management procedures are recommended:

  1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions that may be appropriate based on the clinical scenario.

  4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these general management strategies in the event of an overdose, despite the lack of specific overdosage information.

Nonclinical Toxicology

There is no relevant information available regarding teratogenic effects, non-teratogenic effects, or any other nonclinical toxicology data. Additionally, no findings from animal pharmacology and toxicology studies have been provided.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult their doctor if they experience symptoms accompanied by fever, rash, or a persistent headache. Additionally, if a cough persists for more than one week or tends to recur, patients should be encouraged to seek medical advice. It is important to communicate that a persistent cough may indicate a serious underlying condition that requires further evaluation.

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 15° to 30°C (59° to 86°F) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every four hours as needed. For children aged 6 to 10 years, the dosage is half a tablet every four hours as needed. It is advised that children under 6 years of age consult a doctor before use. Patients should not exceed six doses within a 24-hour period unless directed by a healthcare professional.

Drug Information (PDF)

This file contains official product information for Foster and Thrive Chest Congestion 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 Chest Congestion 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.