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Family Wellness 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 18, 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 18, 2024
Manufacturer
Family Dollar Services Inc
Registration number
M012
NDC root
55319-891
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 out bothersome mucus from your airways. By doing so, it helps make your coughs more productive, allowing you to breathe more comfortably.

Uses

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

Additionally, it makes your coughs more productive, meaning that when you do cough, it can help 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. However, make sure not to exceed 6 tablets in a 24-hour period to avoid any potential issues.

For children aged 6 to under 12 years, the recommended dosage is 1/2 tablet every 4 hours as needed, with a maximum of 3 tablets in a 24-hour period. If your child is under 6 years old, it’s important to consult a doctor before giving them this medication to ensure their safety and proper care.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

You should stop using the medication and consult your doctor if you experience symptoms like fever, rash, or a persistent headache. Additionally, if your cough lasts more than a week or keeps coming back, it's best to stop using the medication and talk to your doctor.

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 talk to your doctor if you have a long-lasting cough due to smoking, asthma, bronchitis, or emphysema, especially if your cough comes with a lot of mucus.

Keep this medication out of reach of children. If you think you or someone else has taken too much, seek medical help right away or call the Poison Control Center at 1-800-222-1222.

You should stop using this medication and contact your doctor if you experience symptoms like fever, rash, or a persistent headache, or if your cough lasts more than a week or keeps coming back, 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 the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

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 your child, it's important to follow the recommended dosages based on their age. For children aged 12 and older, you can give them 1 tablet every 4 hours as needed, but make sure they do not take more than 6 tablets in a 24-hour period. For children between 6 and 12 years old, the dosage is 1/2 tablet every 4 hours, with a maximum of 3 tablets in a day.

If your child is under 6 years old, it's crucial to consult a doctor before administering this medication. Always ensure you adhere to these guidelines to keep your child safe and healthy.

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 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 know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support 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 the medication is generally considered safe to use alongside other treatments or tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance and safety 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 integrity of the device.

When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use. If you have any questions about disposal or further handling, consult the provided guidelines or your healthcare professional.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

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, not exceeding 6 tablets in 24 hours.

What is the recommended dosage for children aged 6 to under 12?

Children aged 6 to under 12 years should take 1/2 tablet every 4 hours as needed, not exceeding 3 tablets in 24 hours.

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 contraindications for this drug?

No contraindications are listed for this drug.

What should I do in case of overdose?

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

What should I do if my symptoms persist?

Stop use and ask a doctor if symptoms are accompanied by fever, rash, or persistent headache, or if cough persists for more than 1 week.

Is this drug safe to use during pregnancy or breastfeeding?

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

What should I keep in mind regarding storage?

Store the drug at 15°-30°C (59°-86°F).

Are there any specific warnings for this drug?

Ask a doctor before use if you have a persistent or chronic cough, or if your cough is accompanied by excessive phlegm (mucus).

Packaging Info

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

Packaging configurations for Family Wellness Chest Congestion Relief.
Details

Drug Information (PDF)

This file contains official product information for Family Wellness Chest Congestion Relief, 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 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.

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

Dosage and Administration

Adults and children 12 years of age and over are advised to take 1 tablet every 4 hours as needed, with a maximum dosage not to exceed 6 tablets within a 24-hour period.

For children aged 6 to under 12 years, the recommended dosage is 1/2 tablet every 4 hours as needed, with a maximum limit of 3 tablets in a 24-hour period.

It is important to note that for children under 6 years of age, consultation with a healthcare professional is required prior to administration.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to keep the product out of reach of children. In the event of an overdose, seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should discontinue use and consult a healthcare professional if symptoms are accompanied by fever, rash, or a 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 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 essential to keep this medication out of the reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Patients are advised to discontinue use and consult their doctor if they experience symptoms such as fever, rash, or a persistent headache. Furthermore, if a cough persists for more than one week or tends to recur, medical evaluation is warranted, as a persistent cough may indicate a serious underlying condition.

In cases of overdose, it is critical to obtain emergency medical help or contact the Poison Control Center immediately at 1-800-222-1222.

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 experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice.

Patients are instructed to discontinue use and consult 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, it is essential to seek medical attention, as a persistent cough 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 Family Wellness Chest Congestion Relief (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Family Wellness 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 tablets in a 24-hour period. For children aged 6 to under 12 years, the recommended dosage is 1/2 tablet every 4 hours as needed, not to exceed 3 tablets in 24 hours.

For children under 6 years of age, it is advised to consult a doctor before administration.

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. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed 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 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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the substance involved. Consultation with a poison control center or toxicology expert is recommended for guidance on the appropriate management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided 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 at 1-800-222-1222.

Patients should be informed to discontinue use and consult their doctor if they experience symptoms accompanied by fever, rash, or a persistent headache. Additionally, they should be cautioned to stop use and seek medical advice if their cough persists for more than one week or tends to recur, as a persistent cough may indicate a serious underlying condition.

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. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Family Wellness 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 Family Wellness 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

Last AI update:

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.