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Leader Adult Tussin Mucus and Chest Congestion 541

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Active ingredient
Guaifenesin 200 mg/10 mL
Other brand names
Drug class
Expectorant
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
September 20, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 200 mg/10 mL
Other brand names
Drug class
Expectorant
Dosage form
Liquid
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 2024
Label revision date
September 20, 2024
Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER
Registration number
M012
NDC root
70000-0696
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Adult Tussin is a medication designed to help relieve mucus and chest congestion. It contains guaifenesin (an expectorant) at a strength of 200 mg per 10 mL, which works by loosening phlegm and thinning bronchial secretions, making it easier for you to drain your bronchial tubes. This product is suitable for individuals aged 12 and over and comes in a pleasant cherry flavor.

If you're experiencing discomfort from mucus buildup, Adult Tussin may provide relief by helping to clear your airways, allowing for easier breathing.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it aids in draining your bronchial tubes, which can be particularly helpful if you're experiencing chest congestion.

If you're dealing with mucus buildup, this treatment can effectively relieve that congestion, making it easier for you to breathe comfortably.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. For adults and children aged 12 years and older, the recommended dose is between 10 mL and 20 mL every 4 hours. However, it's important not to take more than 6 doses within a 24-hour period. To ensure accurate dosing, always use the measuring cup that comes with the product and keep it together with the medication.

Please note that this product is not intended for children under 12 years of age. If you have a child who is younger than 12, it's best to consult a doctor for advice on appropriate treatment.

What to Avoid

It's important to be cautious when using this medication. You should not take it if your cough lasts more than 7 days, returns after improvement, or is accompanied by symptoms like fever, rash, or a persistent headache. These signs could indicate a more serious condition that requires medical attention.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always prioritize your health and consult with a healthcare professional if you have any questions or concerns about your symptoms or treatment.

Side Effects

If you experience a cough that lasts more than 7 days, returns, or is accompanied by a fever, rash, or persistent headache, it's important to stop using the medication and consult your doctor. Additionally, if you have a cough that produces a lot of mucus or if your cough is chronic—such as those associated with smoking, asthma, chronic bronchitis, or emphysema—you should also speak with your doctor before using this medication.

Warnings and Precautions

It's important to be aware of certain precautions while using this medication. If you experience a cough that lasts more than 7 days, returns after improvement, or is accompanied by a fever, rash, or a persistent headache, you should stop taking the medication and contact your doctor for further advice.

In the event of an overdose, seek emergency medical help immediately or contact a Poison Control Center. Staying informed and attentive to your body's responses can help ensure your safety while using this medication.

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

This product is designed for adults and should not be used in children under 12 years of age. If you have a child who is younger than 12 and you think they may need this medication, it’s important to consult with a doctor first. They can provide guidance on safe alternatives or appropriate treatments for your child's specific needs. Always prioritize your child's health and safety by seeking professional advice.

Geriatric Use

This product is designed for adults and children aged 12 years and older, with a recommended dose of 10 mL to 20 mL every four hours. While there are no specific dosage adjustments or safety concerns mentioned for older adults, it's always wise to consult with a healthcare provider before starting any new medication.

As you consider this product for yourself or an older loved one, remember that individual health conditions can vary widely. If you have any concerns about how this medication may affect you or your caregiver, discussing these with a doctor can help ensure safe and effective use.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your kidneys may not process the medication as effectively. To ensure your safety, your healthcare provider will monitor your kidney function regularly, especially if you have reduced renal function.

Before starting any new treatment, renal function tests (which measure how well your kidneys are working) should be done, and these tests will continue periodically throughout your therapy. If you have severe renal impairment, extra caution is necessary, and your doctor will take special care in managing your treatment.

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, so don't hesitate to ask questions or express any concerns you may have.

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 may not have known conflicts with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective based on your unique health situation.

Always discuss any changes in your medication or health status with your healthcare provider to avoid 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 20-25°C (68-77°F). It's important to keep it away from direct light, as exposure can affect its effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any additional safety instructions provided to ensure safe use and disposal.

Additional Information

You can take this medication orally, with the recommended dosage for adults and children aged 12 years and older being 10 mL to 20 mL every 4 hours. If the patient is under 12 years old, it's important to consult a doctor for the appropriate dosage. Always follow your healthcare provider's instructions for safe and effective use.

FAQ

What is Adult Tussin used for?

Adult Tussin is an expectorant that helps loosen phlegm (mucus) and relieve chest congestion.

What is the active ingredient in Adult Tussin?

The active ingredient in Adult Tussin is Guaifenesin, USP 200 mg per 10 mL.

Who can use Adult Tussin?

Adult Tussin is intended for adults and children aged 12 years and over.

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

The recommended dosage is 10 mL to 20 mL every 4 hours, not to exceed 6 doses in 24 hours.

What should I do if my cough lasts more than 7 days?

You should stop using Adult Tussin and ask a doctor if your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

Can I use Adult Tussin if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Adult Tussin.

How should I store Adult Tussin?

Store Adult Tussin at 20-25°C (68-77°F) and protect it from light.

What should I do in case of an overdose?

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

Is there any specific information for patients with renal impairment?

Yes, patients with renal impairment may need dosage adjustments and should have their renal function monitored regularly.

Are there any contraindications for using Adult Tussin?

No specific contraindications are listed for Adult Tussin.

Packaging Info

Below are the non-prescription pack sizes of Leader Adult Tussin Mucus and Chest Congestion 541 (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Leader Adult Tussin Mucus and Chest Congestion 541.
Details

Drug Information (PDF)

This file contains official product information for Leader Adult Tussin Mucus and Chest Congestion 541, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Guaifenesin is an expectorant formulated at a concentration of 200 mg per 10 mL. It is designed to assist in loosening and relieving mucus and chest congestion. The product is flavored with cherry and is intended for use in individuals aged 12 years and older.

Uses and Indications

This drug is indicated for the management of conditions associated with excessive mucus production and bronchial congestion. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating drainage of the bronchial tubes. Additionally, it effectively loosens and relieves mucus and chest congestion.

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

Dosage and Administration

The product should be shaken well before each use. For adults and children aged 12 years and older, the recommended dosage is 10 mL to 20 mL administered every 4 hours as needed. It is important to measure the dosage using only the dosing cup provided with the product, and to keep the dosing cup with the product at all times.

Healthcare professionals should advise patients not to exceed 6 doses within a 24-hour period. This product is not intended for use in children under 12 years of age; for this population, consultation with a healthcare provider is recommended.

Contraindications

Use is contraindicated in patients with a cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These conditions may indicate a more serious underlying issue that requires medical evaluation.

Warnings and Precautions

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately. Prompt action is crucial to ensure patient safety and effective management of the situation.

Healthcare professionals should advise patients to discontinue use and consult a physician if a cough persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These signs may indicate a more serious underlying condition that requires further evaluation and intervention.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may necessitate immediate medical attention. Patients are advised to stop use and consult a healthcare professional if their cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache.

Additionally, patients should seek medical advice before using this medication if they have a cough that occurs with excessive phlegm (mucus) or if they have a chronic cough, which may be associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. These considerations are important to ensure the safe and effective use of the medication.

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 Leader Adult Tussin Mucus and Chest Congestion 541 (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Leader Adult Tussin Mucus and Chest Congestion 541.
Details

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. For children under 12 years, it is advised to consult a healthcare professional before use.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, may use this product; however, no specific geriatric use information or dosage adjustments are provided in the prescribing information. The recommended dosage for adults and children aged 12 years and older is 10 mL to 20 mL every 4 hours.

While there are no stated safety concerns or special precautions for elderly patients in the provided text, healthcare providers should remain vigilant and monitor for any potential adverse effects, as individual responses may vary. It is advisable to assess the overall health status and any concomitant medications of geriatric patients to ensure safe and effective use of this product.

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 currently no available data regarding 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

Patients with renal impairment may necessitate dosage adjustments based on their level of renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels, and renal function tests are recommended prior to initiating therapy and periodically thereafter. Special caution is advised in patients with severe renal impairment to ensure safety and efficacy of treatment.

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 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 exposure, is crucial for effective management 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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is essential for patients to understand the seriousness of an overdose and the importance of prompt action to ensure their safety.

Storage and Handling

The product is supplied in packaging that ensures its integrity during storage and handling. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Additionally, it is essential to protect the product from light to prevent degradation. Proper adherence to these storage conditions is crucial for preserving the quality of the product.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 10 mL to 20 mL every 4 hours. For children under 12 years, it is advised to consult a doctor for appropriate dosing.

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

Drug Information (PDF)

This file contains official product information for Leader Adult Tussin Mucus and Chest Congestion 541, 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 Leader Adult Tussin Mucus and Chest Congestion 541, 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.