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Guaifenesin/Dextromethorphan hydrobromide

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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 2019
Label revision date
May 17, 2024
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 2019
Label revision date
May 17, 2024
Manufacturer
OPMX LLC
Registration number
M012
NDC root
69729-783
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

Tenalif® is a medication designed for adults that combines two active ingredients: Dextromethorphan HBr, which is a cough suppressant, and Guaifenesin, an expectorant. This combination works to help control your cough while also loosening and thinning mucus in your airways. By making coughs more productive, Tenalif® can assist in clearing phlegm (mucus) from your respiratory system, making it easier for you to breathe.

Available in a box of 20 softgels, Tenalif® is intended to provide relief from cough and congestion, helping you feel more comfortable when dealing with respiratory issues.

Uses

If you're dealing with a cough or congestion, this medication can be quite helpful. It works by loosening phlegm (a type of mucus) and thinning bronchial secretions, which can make your coughs more productive. This means that when you do cough, it can help clear out mucus more effectively.

In addition to helping with mucus, this medication also helps control your cough, making it easier for you to breathe and feel more comfortable. Overall, it’s designed to support your respiratory health by addressing both mucus and cough symptoms.

Dosage and Administration

It's important to follow the dosage instructions carefully when taking this medication. For adults and children aged 12 years and older, you should take 1 softgel every 4 hours as needed, but make sure to drink a full glass of water with it. Remember, you should not take more than 6 softgels in a 24-hour period, and you should not use this medication for more than 7 consecutive days.

If you are caring for a child under 12 years of age, do not use this medication for them. Always stick to the recommended dosage to ensure your safety and effectiveness of the treatment.

What to Avoid

You should avoid using this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of drug used for depression, psychiatric, or emotional conditions, or Parkinson's disease. Additionally, you should not take this medication for at least two weeks after stopping an MAOI. If you're unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist before using this product.

It's important to follow these guidelines to prevent serious interactions and ensure your safety. Always prioritize open communication with your healthcare provider regarding any medications you are taking.

Side Effects

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

In the event of an overdose, seek medical help immediately or contact a Poison Control Center, as quick medical attention is crucial for both adults and children, even if no symptoms are apparent.

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. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

Before using this product, 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 medical help immediately or contact a Poison Control Center. Quick medical attention is essential for both adults and children, even if you do not see 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. Always err on the side of caution and get help right away if you think an overdose has occurred. Your quick action can make a significant difference in ensuring safety and health.

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 be cautious when considering this medication for children. If your child is under 12 years old, you should not use this product. 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.

Always keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, seek medical help immediately, even if your child does not show any signs or symptoms. Your child's safety is the top priority, so please follow these guidelines carefully.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. They can monitor for any potential side effects and make recommendations based on individual health status. Always prioritize open communication with your healthcare team to ensure the best care.

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 should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

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 may affect you if you have hepatic impairment (liver issues).

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 be cautious about drug interactions when considering any new medication. You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, certain psychiatric conditions, or Parkinson's disease. Additionally, you should wait at least two weeks after stopping an MAOI before starting this product.

If you're unsure whether your current prescription includes an MAOI, it's essential to consult with your doctor or pharmacist. They can provide guidance to ensure your safety and help you avoid any potentially harmful interactions. Always prioritize open communication with your healthcare provider about all medications and treatments you are using.

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 disposal instructions, be sure to follow them to ensure safe and responsible disposal.

Additional Information

No further information is available.

FAQ

What is Tenalif® used for?

Tenalif® is an expectorant and cough suppressant that helps loosen phlegm (mucus) and thins bronchial secretions to make coughs more productive.

What are the active ingredients in Tenalif®?

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

How should I take Tenalif®?

Adults and children 12 years and older should take 1 softgel every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 softgels in 24 hours.

Are there any age restrictions for using Tenalif®?

Children under 12 years of age should not use Tenalif®.

What should I do if I experience an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical.

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

Stop using Tenalif® and consult a doctor if your cough lasts more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

Can I use Tenalif® if I am taking an MAOI?

Do not use Tenalif® if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last 2 weeks.

Is Tenalif® safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using Tenalif®.

How should I store Tenalif®?

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

Packaging Info

Below are the non-prescription pack sizes of Guaifenesin, Dextromethorphan Hbr. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin, Dextromethorphan Hbr.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Tenalif® is a pharmaceutical product indicated for adults, containing the active ingredients dextromethorphan hydrobromide (20 mg) and guaifenesin (400 mg). It functions as both an expectorant and a cough suppressant, effectively controlling cough while thinning and loosening mucus. The product is available in a dosage form of softgels, packaged in a box containing 20 softgels. The National Drug Code (NDC) for Tenalif® is 69729-783-02.

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 control of cough, contributing to improved respiratory function.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. For adults and children aged 12 years and older, the recommended dose is 1 softgel every 4 hours, taken with a full glass of water, as long as symptoms persist. It is imperative that patients do not exceed 6 softgels within a 24-hour period.

The use of this medication should not extend beyond 7 consecutive days. For children under 12 years of age, the use of this product is not recommended. Healthcare professionals should counsel patients to follow these instructions carefully to ensure safe and effective use.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI.

If there is uncertainty regarding the presence of an MAOI in a prescription medication, it is advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this medication.

Warnings The use of this medication is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain drugs prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this medication should not be taken for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their prescription medications.

General Precautions Prior to using this medication, patients should seek medical advice 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 are advised to discontinue use and consult 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 essential for both adults and children, even if no signs or symptoms are initially apparent.

Side Effects

Patients should be advised to discontinue 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 may indicate a serious underlying condition.

Before using this product, patients should seek medical advice if they have a cough that occurs with excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

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

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric disorders, emotional conditions, or Parkinson's disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI.

It is essential for patients to verify whether their prescription medications contain an MAOI. If there is any uncertainty regarding the presence of an MAOI in their current medication regimen, patients are advised to consult with a healthcare professional, such as a doctor or pharmacist, prior to using this product.

Packaging & NDC

Below are the non-prescription pack sizes of Guaifenesin, Dextromethorphan Hbr. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin, Dextromethorphan Hbr.
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.

In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately apparent. It is important to keep this medication out of reach of children to prevent accidental ingestion.

Geriatric Use

There is no specific information available 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 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 have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as there is no available data to guide dosing or monitoring in this population.

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 clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation and monitoring based on individual patient circumstances.

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 crucial 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, vigilance and timely intervention are essential in managing overdose situations effectively.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include dizziness, nausea, vomiting, rash, and allergic reactions, which encompass anaphylaxis. Additionally, cases of hallucinations, confusion, agitation, increased heart rate, and respiratory depression have also been documented. It is important to note that these reactions were reported during the postmarketing experience and may not be directly related to the use of the product.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. Patients should be encouraged to consult with their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Patients should be instructed to stop using the product and seek medical advice if their cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious condition. Additionally, healthcare providers should recommend that patients consult a doctor before using the product if they have a cough that produces excessive phlegm or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

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

No further data are available.

Drug Information (PDF)

This file contains official product information for Guaifenesin, Dextromethorphan Hbr, 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 Guaifenesin, Dextromethorphan Hbr, 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.