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Rugby 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 2020
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 2020
Label revision date
December 18, 2024
Manufacturer
Rugby Laboratories
Registration number
M012
NDC root
0536-1311
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 a cough that feels unproductive or uncomfortable.

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 between the ages of 6 and 10, 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 properly.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. If you experience any symptoms such as fever, rash, or a persistent headache, you should stop using the medication and consult your doctor. Additionally, if your cough lasts more than a week or keeps coming back, it's best to stop using the product and seek medical advice. 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 is related to smoking, asthma, bronchitis, or emphysema. Additionally, if your cough is accompanied by 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), make sure to discuss this with your healthcare provider.

You should stop taking the medication and call your doctor if you experience any of the following: symptoms accompanied by fever, rash, or a persistent headache; a cough that lasts more than a week or keeps coming back; or if you notice that your cough is worsening, as this could indicate a more serious health issue.

In the event of an overdose, seek emergency medical help or contact a Poison Control Center right away. Your safety is important, so please take these precautions seriously.

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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have any concerns about your health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using 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 your child is between 6 to 10 years old, they can take half a tablet every four hours as needed. However, if your child is under 6 years old, it's important to consult a doctor before giving them this medication. Always ensure you follow these guidelines to keep your child safe and healthy.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to discuss any concerns with your healthcare provider. They can help determine the best approach for you, considering any potential interactions or side effects.

If you or a loved one is an older adult, make sure to monitor for any unusual symptoms or changes in health after starting a new medication. Your healthcare provider can provide guidance tailored to your individual situation, ensuring safety and effectiveness in your treatment plan.

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 appropriate for your kidney health.

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 function. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition appropriately.

Make sure to keep your doctor informed about any liver issues you may have, as 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 the medication is generally considered safe to use with other drugs and 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 changes in your medication or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

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 and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal.

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 and helping to clear bothersome mucus from the bronchial passageways.

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, without exceeding 6 doses in a 24-hour period.

What is the dosage for children aged 6 to 10?

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

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

If your child is under 6 years of age, you should consult a doctor before use.

Are there any warnings I should be aware of?

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

When should I stop using this drug and consult a doctor?

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

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately.

Can I use this drug if I am pregnant or breastfeeding?

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

How should I store this drug?

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

Packaging Info

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

Packaging configurations for Rugby Chest Congestion Relief.
Details

Drug Information (PDF)

This file contains official product information for Rugby 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 additional specific description details are provided in the available 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. By enhancing mucociliary clearance, this medication aids in making coughs more productive, thereby improving respiratory function and comfort.

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 before administration.

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

Contraindications

There are no specific contraindications listed for this product. However, it is advised to keep the product out of reach of children.

Patients should 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 experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice before initiating treatment.

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

In the event of an overdose, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay.

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).

Patients are also instructed to discontinue use and consult a doctor 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 may indicate a serious underlying condition, warranting further evaluation by a healthcare provider.

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 Rugby Chest Congestion Relief (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Rugby Chest Congestion Relief.
Details

Pediatric Use

Pediatric patients aged 6 to 10 years may take 1/2 tablet every 4 hours as needed. 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 the safety of both the mother and the developing fetus.

Lactation

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

Renal Impairment

Patients with renal impairment have 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.

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.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of ingestion, is crucial for effective management and treatment planning.

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 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, 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 Rugby 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 Rugby 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.