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Cough Out

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Active ingredient
Guaifenesin 100 mg/5 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 1997
Label revision date
June 18, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 100 mg/5 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 1997
Label revision date
June 18, 2025
Manufacturer
Efficient Laboratories Inc.
Registration number
M012
NDC root
58593-255
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

This medication helps loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to clear your airways of bothersome mucus. By doing so, it can assist in relieving symptoms associated with respiratory conditions, allowing for easier breathing and improved comfort.

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, making it easier for you to cough it up and improve your respiratory comfort.

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

Dosage and Administration

Before using this medication, make sure to shake the bottle well to mix the contents properly. For adults and children aged 12 years and older, the recommended dose is 10 ml (which is equivalent to 2 teaspoons) every 4 hours. If you are giving this medication to children aged 6 to under 12 years, the dose is 5 ml (or 1 teaspoon) every 4 hours.

It's important to remember not to exceed 6 doses within a 24-hour period, regardless of age. If your child is under 6 years old, this medication should not be used. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to be aware of certain precautions when using this medication. While there are no specific contraindications or concerns about abuse, misuse, or dependence (which means relying on a substance in a harmful way), you should be vigilant about the possibility of an accidental overdose. If this occurs, seek medical help immediately or contact the Poison Control Center for assistance.

Always prioritize your safety and well-being by following these guidelines closely. If you have any questions or concerns about your medication, don't hesitate to reach out to your healthcare provider for more information.

Side Effects

It's important to be aware of potential side effects when using this medication. You should not exceed the recommended dosage. If you have a cough that produces a lot of mucus, or if you have a long-lasting cough due to smoking, asthma, chronic bronchitis, or emphysema, consult your doctor before using this product.

If your cough lasts more than a week, keeps coming back, or is accompanied by a fever, rash, or a persistent headache, stop using the medication and seek medical advice. A persistent cough could indicate a more serious health issue.

Warnings and Precautions

It's important to follow the recommended dosage and not exceed it. If you have a cough that produces a lot of mucus or a long-lasting cough due to smoking, asthma, chronic bronchitis, or emphysema, please consult your doctor before using this medication.

You should stop using the medication and contact your doctor if your cough lasts more than a week, keeps coming back, or is accompanied by a fever, rash, or a persistent headache, as these could indicate a more serious health issue.

In the event of an accidental overdose, seek emergency medical help immediately or contact the Poison Control Center for assistance.

Overdose

Taking more than the recommended dosage of a medication can lead to serious health issues. It's important to always follow the dosage instructions provided by your healthcare provider or on the medication label. If you suspect that you or someone else has taken too much, look for signs of an overdose, which may include unusual drowsiness, confusion, or difficulty breathing.

If an overdose occurs, seek immediate medical help. You can call your local emergency number or go to the nearest hospital. Remember, it's always better to be safe and get checked out if you have any concerns about a possible overdose.

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 it comes to using this medication for children, it's important to follow specific guidelines. For children aged 6 to under 12 years, the recommended dosage is 5 ml (which is equivalent to 1 teaspoon) every 4 hours as needed. However, if your child is under 6 years old, you should not use this medication at all, as it is not safe for that age group. Always consult with your child's healthcare provider if you have any questions or concerns about their treatment.

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 for personalized advice. 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 plan.

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 monitor your liver function and determine the best approach for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need 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, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might work together or affect any tests you may need. Your health and safety are the top priority, and discussing your full medication list helps your provider make informed decisions.

Storage and Handling

You can feel confident using this product, as there are no specific storage, handling, or disposal instructions provided. This means you can store it at room temperature and handle it like you would other similar items. Always ensure that you keep it in a clean environment to maintain its integrity. If you have any concerns about safety or usage, please consult your healthcare provider for guidance.

Additional Information

No further information is available.

FAQ

What is the main use of this drug?

This drug helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus.

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

Adults and children 12 years and over should take 10 ml (2 teaspoons) every 4 hours, not exceeding 6 doses in any 24-hour period.

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

Children aged 6 to under 12 years should take 5 ml (1 teaspoon) every 4 hours.

Is this drug safe for children under 6?

No, this drug should not be used in children under 6 years of age.

What should I do in case of an accidental overdose?

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

Are there any warnings associated with this drug?

You should not exceed the recommended dosage and should ask a doctor before use if you have a cough with excessive phlegm or a chronic cough.

What should I do if my cough persists?

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

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.

Are there any known drug interactions?

No specific drug interactions are mentioned for this drug.

What should I do before using this drug?

Shake well immediately before use.

Packaging Info

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

Packaging configurations for Cough Out.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

CoughOutLabel is a pharmaceutical formulation designed for the management of cough symptoms. The product is presented in a liquid dosage form, characterized by its clear appearance. The active ingredients are specifically selected to provide effective relief from cough, while the inactive ingredients ensure stability and palatability. The formulation adheres to established pharmacological standards, ensuring safety and efficacy for the intended use.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients experiencing excessive bronchial secretions. It helps to loosen phlegm and thin bronchial secretions, thereby aiding in the removal of bothersome mucus from the bronchial passageways.

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

Dosage and Administration

The medication should be shaken well immediately before use to ensure proper mixing of the formulation.

For adults and children aged 12 years and older, the recommended dosage is 10 mL (2 teaspoons) administered every 4 hours. It is important to note that the total number of doses should not exceed 6 in any 24-hour period.

For children aged 6 to under 12 years, the recommended dosage is 5 mL (1 teaspoon) every 4 hours, adhering to the same limitation of a maximum of 6 doses within a 24-hour period.

This medication is not recommended for use in children under 6 years of age.

Contraindications

There are no contraindications listed for this product. However, in the event of an accidental overdose, it is imperative to seek medical assistance or contact the Poison Control Center immediately.

Warnings and Precautions

Patients should not exceed the recommended dosage of this medication. Prior to use, it is essential for individuals to consult a healthcare professional if they are experiencing a cough that is accompanied by excessive phlegm (mucus) or if they have a persistent or chronic cough, which may be associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema.

In the event that a cough persists for more than one week, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache, patients are advised to discontinue use and seek medical advice. A persistent cough may indicate an underlying serious condition that requires further evaluation.

In cases of accidental overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is crucial not to exceed the recommended dosage, as doing so may lead to serious complications.

Before using this product, patients are advised to consult a healthcare professional if they have a cough that is accompanied by excessive phlegm (mucus) or if they experience a persistent or chronic cough, which may occur in conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Patients should discontinue use and seek medical advice if their cough persists for more than one week, tends to recur, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires further evaluation.

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 Cough Out (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cough Out.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered a dosage of 5 ml (1 teaspoon) every 4 hours. The use of this medication is not recommended for children under 6 years of age due to safety concerns.

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. It is advisable to monitor these patients closely for any 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 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 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

There is no specific information 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 this patient population.

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

Exceeding the recommended dosage of the medication can lead to serious health consequences. Healthcare professionals are advised to strictly adhere to the prescribed dosage guidelines to mitigate the risk of overdosage.

In the event of suspected overdosage, it is crucial to monitor the patient for potential symptoms that may arise. These symptoms can vary depending on the specific medication involved and may include a range of physiological and psychological effects.

Management of overdosage should be initiated promptly. Healthcare providers should assess the patient's condition and consider supportive care measures. This may involve monitoring vital signs, providing symptomatic treatment, and, if necessary, implementing specific interventions based on the medication's pharmacological profile.

In cases of severe overdosage, consultation with a poison control center or a medical toxicologist is recommended to determine the most appropriate course of action. It is essential to document all findings and interventions thoroughly to ensure comprehensive patient 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 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. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an accidental overdose, healthcare providers should instruct patients to seek medical help immediately or contact the Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in various configurations, with specific NDC numbers available for identification. Currently, there are no specific storage, handling, or disposal instructions provided. Therefore, standard storage practices should be followed, ensuring that the product is kept in a suitable environment to maintain its integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Cough Out, 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 Cough Out, 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.