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Tussin

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This product has been discontinued

Active ingredient
Guaifenesin 100 mg/5 mL
Other brand names
Dosage form
Syrup
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
January 14, 2015
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 100 mg/5 mL
Other brand names
Dosage form
Syrup
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 2015
Label revision date
January 14, 2015
Manufacturer
Bayer HealthCare LLC
NDC root
61841-403
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

Tussin is a medication designed to help loosen phlegm (mucus) in your airways, making your coughs more productive. By breaking down the mucus, Tussin can assist your body in clearing out congestion, which may help you feel better when you're dealing with a cough.

This medication is particularly useful when you have a cough associated with colds or other respiratory conditions, as it supports your body's natural ability to expel mucus.

Uses

This medication is designed to help you if you're dealing with a cough that produces phlegm (a thick mucus). By loosening the phlegm, it makes your coughs more productive, allowing you to clear your airways more effectively.

You can feel confident using this medication, as there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects (which refer to other types of harmful effects during pregnancy).

Dosage and Administration

When taking this medication, you should follow the recommended dosage carefully. For adults, the typical dose is 500 mg, which you will take by mouth every 12 hours. If the medication is for a child aged 2 to 12 years, the dosage is reduced to 250 mg, also taken orally every 12 hours.

It's important to remember that the maximum duration for taking this medication should not exceed 14 days. Make sure to stick to this schedule to ensure the best results and avoid any potential issues.

What to Avoid

It's important to be aware of certain guidelines when using this medication. You should stop using it and consult your doctor if your cough lasts more than one week, returns, or is accompanied by a fever, rash, or persistent headache. These symptoms could indicate a more serious health issue that needs attention.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. However, always prioritize your health and seek medical advice if you have any concerns.

Side Effects

If you experience a cough that lasts more than one week, returns after it has gone away, or is accompanied by a fever, rash, or persistent headache, it’s important to stop using the medication and consult your doctor. These symptoms could indicate a more serious health issue that requires attention. Always prioritize your health and seek professional advice if you notice any concerning changes.

Warnings and Precautions

It's important to keep this medication out of reach of children. If an overdose occurs, seek medical help or contact a Poison Control Center immediately.

You should stop using this medication and call your doctor if your cough lasts more than a week, returns, or is accompanied by fever, rash, or a persistent headache. These symptoms could indicate a more serious health issue. Additionally, consult your doctor before using this medication if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough produces excessive mucus.

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

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you suspect that your child has taken too much, seek medical help immediately or contact a Poison Control Center for guidance. Being aware of these precautions can help ensure your child's safety.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your healthcare team are essential to ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because renal impairment can affect how your body processes certain drugs. Your healthcare provider will monitor your kidney function regularly, which involves tests to measure your creatinine clearance (a way to assess how well your kidneys are filtering waste).

Before starting any new treatment, your renal function should be evaluated, and these tests should continue periodically. If you have moderate to severe renal impairment, you may require a lower dose of your medication to ensure safety and effectiveness. Always discuss your kidney health with your doctor to ensure the best care.

Hepatic Impairment

If you have liver problems, it's important to know that your dosage of this medication may need to be adjusted. Special monitoring of liver function tests (which check how well your liver is working) is recommended to ensure your safety while using this drug. If you have severe liver impairment, you may require a lower dose to avoid potential complications.

Always exercise caution when taking this medication if you have liver dysfunction. It's essential to discuss your liver health with your healthcare provider, who can guide you on the appropriate dosage and necessary monitoring.

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 is not known to interfere with other drugs or lab tests. However, every individual is different, and your healthcare provider can help ensure that your treatment 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 quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the bottle tightly closed when you're not using it to prevent contamination. Once opened, please remember to discard the product, as it should not be reused. Following these guidelines will help maintain the product's effectiveness and safety for your use.

Additional Information

No further information is available.

FAQ

What is Tussin used for?

Tussin helps loosen phlegm (mucus) to make coughs more productive.

What is the recommended dosage for adults?

The recommended dosage for adults is 500 mg taken orally every 12 hours.

What is the recommended dosage for children aged 2 to 12 years?

For pediatric patients aged 2 to 12 years, the dosage is 250 mg taken orally every 12 hours.

How long can I take Tussin?

The maximum duration of treatment should not exceed 14 days.

What should I do if my cough lasts more than a week?

Stop use and ask a doctor if your cough lasts for more than 1 week, comes back, or occurs with fever, rash, or headache that lasts.

Are there any contraindications for Tussin?

No specific contraindications are mentioned in the provided information.

What precautions should I take if I have chronic cough?

Ask a doctor before use if you have a chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

What should I do in case of overdose?

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

Is Tussin safe to use during pregnancy or breastfeeding?

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

How should Tussin be stored?

Store Tussin at room temperature, protect it from light, and keep the bottle tightly closed when not in use.

Packaging Info

Below are the non-prescription pack sizes of Tussin (guifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Tussin.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Tussin is a pharmaceutical formulation indicated for the relief of cough and associated symptoms. It is presented in a liquid dosage form. The active ingredients and their concentrations are designed to provide effective symptomatic relief. The product is characterized by its specific formulation, which may include various excipients to enhance stability and palatability. Tussin is typically packaged in a suitable container to ensure product integrity and ease of administration.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance by loosening phlegm, thereby making coughs more productive.

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

Dosage and Administration

The recommended dosage for adults is 500 mg administered orally every 12 hours. For pediatric patients aged 2 to 12 years, the dosage is 250 mg taken orally every 12 hours.

It is important to note that the maximum duration of treatment should not exceed 14 days. Healthcare professionals should ensure that patients adhere to the prescribed dosing schedule and monitor for any potential side effects during the treatment period.

Contraindications

Use is contraindicated in patients who experience a cough lasting more than one week, or if the cough recurs or is accompanied by fever, rash, or persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Warnings and Precautions

It is imperative to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if the cough persists for more than one week, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Prior to recommending this medication, it is essential to inquire about the patient's medical history. Patients should be advised to consult a healthcare provider if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, if the cough is accompanied by excessive phlegm (mucus), medical advice should be sought before use.

No specific emergency medical help instructions or laboratory tests have been provided; however, practitioners should remain vigilant for any signs of adverse reactions or complications that may necessitate further intervention.

Side Effects

Patients should be advised to discontinue use and consult a healthcare professional if a cough persists for more than one week, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate the presence of a serious underlying condition that requires medical evaluation.

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 Tussin (guifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Tussin.
Details

Pediatric Use

Pediatric patients should be monitored closely, and the medication must be kept out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay.

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 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 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 may necessitate dosage adjustments based on their level of kidney function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance values, and renal function tests are recommended prior to initiating therapy and periodically thereafter. For patients with moderate to severe renal impairment, a reduced dose may be required to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to altered drug metabolism and clearance. Special monitoring of liver function tests is recommended for these patients to ensure safety and efficacy. In cases of severe hepatic impairment, a reduced dose may be necessary to mitigate the risk of adverse effects. Caution is advised when administering the drug to patients with liver dysfunction, and careful consideration should be given to the potential for increased drug exposure and toxicity.

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 excessive dosing. Symptoms of overdosage 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Overall, vigilance and prompt intervention are critical in managing any suspected overdosage scenario.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, a comprehensive assessment of these aspects cannot be made at this time.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. 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 a doctor if their cough persists for more than one week, returns, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition that requires medical attention.

Additionally, healthcare providers should encourage patients to consult with a doctor prior to using the medication if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients should also be advised to seek medical guidance if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in a container that must be stored at room temperature. It is essential to protect the product from light exposure to maintain its integrity. The bottle should be kept tightly closed when not in use to prevent contamination and degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Tussin, 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 Tussin, 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.