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Tesalon Tesaperlas Severe Cold Max Relief

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Active ingredients
  • Guaifenesin 400 mg
  • Dextromethorphan Hydrobromide 20 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Capsule, Liquid Filled
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
January 2, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 400 mg
  • Dextromethorphan Hydrobromide 20 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Capsule, Liquid Filled
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
January 2, 2026
Manufacturer
OPMX LLC
Registration number
M012
NDC root
69729-788
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

Tesalon® (generic name: Tesaperlas) is a medication that serves as both an expectorant and a cough suppressant. It is designed to help control coughs while also thinning and loosening mucus in your airways. This makes it easier for you to cough up phlegm, leading to more productive coughing and relief from congestion.

The formulation of Tesalon® includes dextromethorphan HBr, which helps suppress the cough reflex, and guaifenesin, which aids in thinning bronchial secretions. Together, these ingredients work to improve your breathing comfort when dealing with coughs and mucus buildup.

Uses

This medication is designed to help you manage respiratory issues 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. Additionally, it helps control coughing, providing relief when you need it most.

Overall, this treatment can be beneficial if you're dealing with conditions that cause excessive mucus production or persistent coughs, making it easier for you to breathe and feel more comfortable.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 1 softgel every 4 hours as long as your symptoms continue. Make sure to swallow the softgel with a full glass of water to help it work effectively.

However, if you have a child under 12 years of age, it is important not to use this medication for them. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications or concerns about abuse, misuse, or dependence, you should stop using the medication and consult your doctor if your cough lasts more than 7 days, comes back, or is accompanied by symptoms like fever, rash, or a persistent headache. These could indicate a more serious health issue that needs attention. Always prioritize your health and seek professional advice when needed.

Side Effects

You should be aware of some important warnings and potential side effects associated with this medication. Do not use it if you are currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication for depression or certain other conditions, or for two weeks after stopping an MAOI. If you are unsure whether your prescription contains an MAOI, consult your doctor or pharmacist before taking this product.

It's important to talk to your doctor before using this medication if you have a cough that produces a lot of mucus, or if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema. You should stop using the medication and seek medical advice if your cough lasts more than seven days, comes back, or is accompanied by fever, rash, or a persistent headache, as these could indicate a more serious issue. If you are pregnant or breastfeeding, consult a healthcare professional before use. Always keep this medication out of reach of children, and in case of overdose, seek medical help immediately, even if no symptoms are present.

Warnings and Precautions

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions, or if you have stopped taking an MAOI within the last two weeks. If you are unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist before using this product.

Before using this medication, it’s important to talk to your doctor if you have a cough that produces a lot of mucus, or if your cough is chronic, such as from smoking, asthma, chronic bronchitis, or emphysema. If your cough lasts more than seven days, comes back, or is accompanied by fever, rash, or a persistent headache, stop using the product and contact your doctor, as these may be signs of a more serious condition.

In the event of an overdose, seek emergency medical help or contact a Poison Control Center immediately. Quick medical attention is essential for both adults and children, even if you do not notice any immediate symptoms.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. Remember, prompt medical attention can make a significant difference, so don’t hesitate to reach out for help.

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 you are considering this medication for your child, it's important to know that it should not be used in children under 12 years of age. For those aged 12 and older, the recommended dosage is one softgel every four hours, taken with a full glass of water, as long as symptoms continue.

Be aware that in case of an overdose, it is crucial to seek medical help immediately, even if your child shows no signs of distress. Always keep this medication out of reach of children to ensure their 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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (issues with liver function).

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 or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20-25°C (68-77°F). It's important to keep it away from excessive heat and humidity, as these conditions can affect its quality and effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific components that come with the product, make sure to follow any additional instructions provided for their use and safety. Proper storage and handling will help you get the most out of your product.

Additional Information

You should take this medication orally, with adults and children aged 12 and over advised to take 1 softgel every 4 hours as needed, accompanied by a full glass of water. If you are caring for a child under 12 years old, do not use this medication for them. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Tesalon® used for?

Tesalon® is an expectorant and cough suppressant that helps control cough, thin bronchial secretions, and loosen phlegm (mucus) to make coughs more productive.

What is the dosage for adults and children over 12?

Adults and children 12 years of age and over should take 1 softgel every 4 hours with a full glass of water while symptoms persist.

Can children under 12 use Tesalon®?

No, Tesalon® should not be used by 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, recurs, or is accompanied by fever, rash, or persistent headache.

Are there any contraindications for using Tesalon®?

There are no specific contraindications listed for Tesalon®.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away, as prompt medical attention is critical.

Is it safe to use Tesalon® during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Tesalon®.

What are the storage instructions for Tesalon®?

Store Tesalon® at room temperature between 20-25°C (68-77°F) and avoid excessive heat and humidity.

What are the active ingredients in Tesalon®?

Tesalon® contains Dextromethorphan HBr 20 mg and Guaifenesin 400 mg.

What should I do if I am taking a monoamine oxidase inhibitor (MAOI)?

Do not use Tesalon® if you are currently taking a prescription MAOI or for 2 weeks after stopping the MAOI drug.

Packaging Info

Below are the non-prescription pack sizes of Tesalon Tesaperlas Severe Cold Max Relief (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Tesalon Tesaperlas Severe Cold Max Relief.
Details

Drug Information (PDF)

This file contains official product information for Tesalon Tesaperlas Severe Cold Max Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the management of respiratory conditions characterized by excessive mucus production. It helps to loosen phlegm (mucus) and thins bronchial secretions, thereby facilitating more productive coughs. Additionally, this drug provides cough control and aids in the thinning and loosening of mucus.

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

Dosage and Administration

Adults and children 12 years of age and older are advised to take 1 softgel every 4 hours, accompanied by a full glass of water, as long as symptoms persist.

The use of this medication is not recommended for children under 12 years of age.

Contraindications

Use is contraindicated in patients who experience a cough lasting more than 7 days, 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 adhere to the following warnings and precautions to ensure the safe use of this product.

Warnings

This product must not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be used for a period of two weeks following the cessation of an MAOI. If there is uncertainty regarding whether a current prescription contains an MAOI, it is essential to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

General Precautions

Healthcare professionals should advise patients to seek medical consultation before using this product if they experience a cough that is productive with excessive phlegm (mucus) or if they have a chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Stop Taking and Call Your Doctor Instructions

Patients should discontinue use and contact a healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Get Emergency Medical Help Instructions

In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical attention is vital for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in specific populations. It is contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or for those who have stopped taking an MAOI within the last two weeks. Patients should consult a healthcare professional if they are uncertain whether their prescription medication contains an MAOI.

Common adverse reactions may include cough that occurs with excessive phlegm or chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. Patients are advised to seek medical advice before using this product if they experience these symptoms.

Patients should discontinue use and consult a healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

For pregnant or breastfeeding patients, it is recommended to seek guidance from a healthcare professional prior to use. Additionally, this product should be kept out of reach of children to prevent accidental ingestion.

In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Tesalon Tesaperlas Severe Cold Max Relief (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Tesalon Tesaperlas Severe Cold Max Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 1 softgel every 4 hours with a full glass of water, as needed while symptoms persist.

Healthcare professionals should be aware of the overdose warning, which emphasizes the importance of seeking prompt medical attention for both adults and children, even in the absence of noticeable signs or symptoms. Additionally, this medication should be kept out of reach of children to prevent accidental ingestion.

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.

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 considered, 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 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, it is essential to monitor the patient closely and provide supportive care as necessary.

Management of an overdose may involve symptomatic treatment and monitoring of vital signs, as well as specific interventions based on the substance involved. It is crucial to follow established protocols and guidelines for overdose management to ensure the safety and well-being of the patient.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

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. Patients should be instructed to stop using the medication and consult a doctor if their cough lasts more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or persistent headache, as these may indicate a serious underlying condition.

Additionally, healthcare providers should encourage patients to seek medical advice before using the medication if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. This precaution is important to ensure the 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 should be stored at room temperature, ideally between 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat and humidity to maintain product integrity. Proper storage conditions are essential to ensure the efficacy and safety of the product.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one softgel every four hours, taken with a full glass of water, as long as symptoms persist. It is contraindicated for use in children under 12 years of age. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Tesalon Tesaperlas Severe Cold Max 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 Tesalon Tesaperlas Severe Cold Max 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.

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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.