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Tussin Mucus and Chest Congestion Sugar Free

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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 2025
Label revision date
May 15, 2023
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 2025
Label revision date
May 15, 2023
Manufacturer
AARNA USA, Inc.
Registration number
M012
NDC root
82568-0012
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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 your coughs more productive. By doing so, it can assist your body in clearing out mucus from your airways, which may help you breathe easier and feel more comfortable when you're dealing with respiratory issues.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it makes your coughs more productive, allowing you to clear your airways more effectively.

You can rely on this treatment to support your respiratory health, especially when dealing with conditions that cause excessive mucus production.

Dosage and Administration

When using this medication, it's important to follow the recommended dosage to ensure your safety and effectiveness. For adults and children aged 12 years and older, you should take 10 to 20 mL every 4 hours as needed. However, make sure not to exceed 6 doses within a 24-hour period.

Please note that this product is not suitable for children under 12 years of age, so if you have younger children, do not use this medication for them. Always adhere to these guidelines to help manage your health effectively.

What to Avoid

If you are using this medication, it's important to know when to stop. You should stop using it and consult your doctor if your cough lasts more than 7 days, returns after improvement, or is accompanied by symptoms like fever, rash, or a persistent headache. These 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. Always prioritize your health and seek medical advice if you have any concerns.

Side Effects

If you experience a cough that lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, it's important to stop using the medication and consult a doctor, as these symptoms may indicate a serious condition. Additionally, you should speak with a healthcare professional before using this medication if your cough is associated with excessive mucus or if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have a cough that produces a lot of phlegm (mucus) or if your cough is chronic, such as those caused by smoking, asthma, chronic bronchitis, or emphysema.

You should stop using the medication and contact your doctor if your cough lasts more than 7 days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache, as these may indicate a more serious health issue. If you suspect an overdose, seek emergency medical help immediately or call a Poison Control Center at 1-800-222-1222.

If you are pregnant or breastfeeding, please consult a healthcare professional before using this medication. Additionally, keep this product out of reach of children to ensure their safety.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is the top priority.

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 specifically designed for adults and should not be used in children under 12 years of age. If your child is younger than 12, it is important to avoid using this medication altogether. Always consult with a healthcare professional if you have questions about appropriate treatments for your child.

Geriatric Use

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

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

Renal Impairment

It appears that there is no specific information regarding dosage adjustments, monitoring, or safety considerations for patients with kidney problems in the provided text. Therefore, if you have kidney issues, it's important to consult your healthcare provider for personalized advice and recommendations regarding any medications you may be taking. They can provide guidance tailored to your specific health needs.

Hepatic Impairment

If you have liver problems, it's important to know that the provided drug insert does not include specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established guidelines for how this medication should be used in patients with liver impairment.

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 medications 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 at room temperature, specifically between 20º-25ºC (68º-77ºF). It's important to avoid refrigeration, as this can affect the product's effectiveness.

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

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dose is 10 to 20 mL every 4 hours as needed. However, this medication is not recommended for children under 12 years old. If you have any questions about how to use this medication, be sure to consult with your healthcare provider.

FAQ

What does this drug do?

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

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

Adults and children 12 years and over should take 10 - 20 mL every 4 hours, but do not exceed 6 doses in any 24-hour period.

Is this drug safe for children under 12?

No, this adult product is not intended for use in children under 12 years of age.

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

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

Are there any warnings for using this drug?

Yes, ask a doctor before use if you have a cough that occurs with too much phlegm or if your cough is chronic, such as 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 at 1-800-222-1222.

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 between 20º-25ºC (68º-77ºF) and do not refrigerate.

Packaging Info

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

Packaging configurations for Tussin Mucus and Chest Congestion Sugar Free.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is associated with various multimedia files, including images of packaging labels and containers. Specific details regarding the chemical name, physical characteristics, or inactive ingredients are not provided.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients with respiratory conditions. It helps to loosen phlegm and thin bronchial secretions, thereby making coughs more productive.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to administer 10 to 20 mL every 4 hours as needed. It is imperative that no more than 6 doses are taken within a 24-hour period to avoid potential overdose. This product is not intended for use in children under 12 years of age.

Contraindications

Use is contraindicated in patients who experience a cough lasting more than 7 days, a recurrent cough, or a cough accompanied by fever, rash, or persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this medication.

Patients should be advised to consult a physician prior to use if they present with a cough that is productive of excessive phlegm (mucus) or if they have a chronic cough, particularly in cases related to smoking, asthma, chronic bronchitis, or emphysema. These conditions may necessitate further evaluation and management.

Instruct patients to discontinue use and seek medical advice if their cough persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires prompt medical attention.

In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center at 1-800-222-1222. Timely intervention is critical in managing potential overdose situations.

General precautions should be taken into account, particularly for individuals who are pregnant or breastfeeding. It is essential for these patients to consult a healthcare professional before using this medication to ensure safety for both the mother and child.

Finally, it is imperative to keep this medication out of the reach of children to prevent accidental ingestion and potential harm.

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 a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms could indicate a serious underlying condition.

Additionally, patients should seek medical advice prior to using this medication if they have a cough that occurs with excessive phlegm (mucus) or if they have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. These conditions may require a different therapeutic approach or further evaluation by a healthcare provider.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for Tussin Mucus and Chest Congestion Sugar Free.
Details

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. The safety and efficacy of this medication have not been established in children within this age group. Therefore, it is contraindicated for use in individuals under 12 years.

Geriatric Use

Elderly patients may use this adult product; however, no specific geriatric use information or dosage adjustments have been established for this population. The recommended dosage for adults and children aged 12 years and older is 10 to 20 mL every 4 hours.

While there are no safety concerns or special precautions specified for elderly patients, healthcare providers should continue to monitor this population for any potential adverse effects, given the general considerations for pharmacotherapy in older adults. It is advisable to assess each geriatric patient's individual health status and response to treatment when prescribing this medication.

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

There is no information available regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific guidelines or recommendations are not provided.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any nonclinical toxicology data. Additionally, no details are provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Additionally, patients should be encouraged to consult with their healthcare provider prior to use if they have a cough associated with excessive phlegm (mucus) or if they have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. This precaution is essential to ensure safe and effective use of the medication.

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 20º-25ºC (68º-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling should be observed to maintain the quality and efficacy of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 10 to 20 mL every 4 hours for adults and children aged 12 years and older. It is contraindicated for use in children under 12 years of age. 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 Tussin Mucus and Chest Congestion Sugar Free, 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 Mucus and Chest Congestion Sugar Free, 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.