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Biocotron

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This product has been discontinued

Active ingredients
  • Guaifenesin 350 mg/5 mL
  • Dextromethorphan Hydrobromide 15 mg/5 mL
  • Phenylephrine Hydrochloride 10 mg/5 mL
Other brand names
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 2015
Label revision date
December 20, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 350 mg/5 mL
  • Dextromethorphan Hydrobromide 15 mg/5 mL
  • Phenylephrine Hydrochloride 10 mg/5 mL
Other brand names
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 2015
Label revision date
December 20, 2024
Manufacturer
Advanced Generic Corporation
Registration number
M012
NDC root
45737-261
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

This medication is a non-narcotic cough suppressant designed to temporarily calm your cough caused by minor throat and bronchial irritation, which can happen with the common cold. It works by calming the cough control center in your brain and helps to loosen phlegm (mucus), making your coughs more productive by thinning bronchial secretions.

In addition to relieving cough, this medication also helps to temporarily relieve nasal congestion and pressure associated with the common cold, making it easier for you to breathe.

Uses

This medication is a non-narcotic cough suppressant that helps calm your cough, especially when it's caused by minor throat and bronchial irritation, such as what you might experience with a common cold. By acting on the cough control center in your brain, it effectively reduces the urge to cough.

In addition to soothing your cough, this medication also helps loosen phlegm (mucus) and thin out bronchial secretions. This makes it easier for your body to clear out mucus from your airways, leading to more productive coughs. If you're dealing with nasal congestion from a cold, this medication can temporarily relieve that as well, helping to decongest your sinus openings and alleviate pressure in your sinuses.

Dosage and Administration

You should take this medication every 4 hours, but make sure not to exceed 6 doses in a 24-hour period unless your doctor advises otherwise.

For adults and children aged 12 years and older, the recommended dose is 1 teaspoonful (which is 5 mL) every 4 hours. If your child is between 6 and 12 years old, they should take 1/2 teaspoonful (2.5 mL) every 4 hours. For children under 6 years of age, it’s important to consult a doctor before giving them this medication. Always follow these guidelines to ensure safe and effective use.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance) or any explicit instructions advising against its use. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

You should be aware of some potential side effects and warnings associated with this product. It's important not to exceed the recommended dosage. If you experience a persistent cough that lasts more than a week, recurs, or is accompanied by fever, rash, or a persistent headache, consult your doctor, as this may indicate a serious condition.

Additionally, avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression or other psychiatric conditions, or if you have taken one in the past two weeks. Before using this product, talk to your doctor or pharmacist if you have a chronic cough, high blood pressure, heart disease, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate. If you notice nervousness, dizziness, or sleeplessness, or if your symptoms do not improve within seven days or are accompanied by fever, stop using the product and consult your doctor.

Warnings and Precautions

It's important to follow the recommended dosage when using this product. If you have a cough that lasts more than a week, keeps coming back, or is accompanied by fever, rash, or a persistent headache, you should consult your doctor. Avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression or other emotional conditions, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your medication contains an MAOI, please ask your doctor or pharmacist.

Before using this product, talk to your doctor or pharmacist if you have a chronic cough (like from smoking or asthma), high blood pressure, heart disease, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate. If you experience nervousness, dizziness, or sleeplessness, or if your symptoms do not improve within seven days or are accompanied by fever, stop using the product and consult your doctor. In case of an accidental overdose, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

Taking more than the recommended dosage of a medication can lead to serious health risks. It's important to always follow the dosage instructions provided by your healthcare provider or on the medication label. Exceeding this amount can result in an overdose, which may cause harmful effects.

If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing (respiratory depression). If you notice any of these symptoms, seek immediate medical help. Always err on the side of caution—if you are unsure or feel unwell after taking your medication, contact a healthcare professional right away.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you make the safest choice for you and your baby. Always prioritize open communication with your doctor regarding any medications you may consider during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult your doctor 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 healthcare provider to ensure safe practices while nursing.

Pediatric Use

When it comes to giving this medication to children, it's important to follow specific guidelines. For children aged 6 to under 12 years, the recommended dosage is 1/2 teaspoonful (2.5 mL) every 4 hours. However, if your child is under 6 years old, you should consult a doctor before administering the medication. This ensures that you are making the safest choice for your child's health. Always prioritize professional advice when it comes to younger children.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to remember that each person’s health needs can vary. Since the insert does not mention any age-related dosage adjustments, safety concerns, or special precautions for elderly patients, you should always consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is appropriate for your individual health situation and any other medications you may be taking.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines provided for dosage adjustments or monitoring related to renal impairment (kidney issues) for this medication. This means that the standard dosing may not be tailored to your condition.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective, especially if you have concerns about your kidney health. They can help determine the best approach for your specific situation.

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

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your liver is functioning well while you are on medication. Your safety and well-being are the top priority, so don’t hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be cautious when taking this product, especially if you are currently using certain medications. Specifically, you should not use this product if you are taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression or other emotional conditions. You also need to wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your medication includes an MAOI, please consult your doctor or pharmacist.

Additionally, if you are taking sedatives or tranquilizers, it's wise to talk to your healthcare provider before using this product. Discussing all your medications and any lab tests with your healthcare provider helps ensure your safety and the effectiveness of your treatments.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It’s okay if the temperature occasionally varies between 15°C to 30°C (59°F to 86°F), but try to keep it within the recommended range. Make sure to protect the product from light and always keep the container tightly closed when not in use.

Once you open the container, remember to discard any remaining product after use to maintain safety and effectiveness. Following these guidelines will help you handle the product safely and ensure it remains in good condition.

Additional Information

You should take this medication orally every 4 hours, but do not exceed 6 doses in a 24-hour period unless directed by your physician. It's important to keep this medication out of the reach of children. If an accidental overdose occurs, seek medical help or contact a Poison Control Center immediately.

If you are pregnant or breastfeeding, consult your doctor before using this medication to ensure it is safe for you.

FAQ

What is the main use of this drug?

This drug is a non-narcotic cough suppressant that temporarily calms cough due to minor throat and bronchial irritation, often associated with the common cold.

How does this drug work?

It calms the cough control center, relieves coughing, helps loosen phlegm (mucus), and temporarily relieves nasal and sinus congestion.

What is the recommended dosage for adults?

Adults and children 12 years of age or older should take 1 teaspoonful (5 mL) every 4 hours, not exceeding 6 doses in 24 hours.

What should I do if my cough persists?

If your cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or a persistent headache, consult a doctor.

Are there any contraindications for this drug?

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks after stopping an MAOI.

What should I do if I experience nervousness or dizziness?

If you experience nervousness, dizziness, or sleeplessness, stop using the drug and consult a doctor.

Is this drug safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a doctor before using this drug.

How should I store this drug?

Store the drug at 20°C to 25°C (68°F to 77°F), protect it from light, and keep the container tightly closed.

Packaging Info

Below are the non-prescription pack sizes of Biocotron (dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Biocotron.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Biocotronped is a pharmaceutical compound identified by its reference value, BioCotronPedv2.jpg. Further details regarding its molecular weight, chemical formula, dosage form, and appearance are not provided in the extracted data.

Uses and Indications

This drug is indicated as a non-narcotic cough suppressant for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with the common cold. It acts on the cough control center to calm coughing and assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the drainage of bronchial tubes and making coughs more productive.

Additionally, this drug provides temporary relief from nasal congestion associated with the common cold. It aids in decongesting sinus openings and passages, offering temporary relief from sinus congestion and pressure.

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

Dosage and Administration

The recommended dosage for this medication is as follows:

For adults and children aged 12 years and older, the dosage is 1 teaspoonful (5 mL) administered every 4 hours. The total daily dosage should not exceed 6 doses within a 24-hour period unless otherwise directed by a physician.

For children aged 6 to under 12 years, the dosage is 1/2 teaspoonful (2.5 mL) every 4 hours, adhering to the same maximum of 6 doses in a 24-hour period.

For children under 6 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Healthcare professionals should ensure that patients are informed of the importance of not exceeding the recommended dosage and to follow any specific instructions provided by their healthcare provider.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

Patients should adhere strictly to the recommended dosage, as exceeding this limit may lead to adverse effects. A persistent cough may indicate a serious underlying condition; therefore, if a cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, it is imperative to consult a healthcare professional.

This product is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or for those who have discontinued MAOI therapy within the past two weeks. Healthcare professionals should be consulted if there is uncertainty regarding the presence of an MAOI in any prescription medication.

Before using this product, patients should seek advice from a healthcare provider or pharmacist if they have any of the following conditions:

  • A persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, particularly if accompanied by excessive phlegm, unless directed otherwise by a physician.

  • High blood pressure.

  • Heart disease.

  • Thyroid disease.

  • Diabetes.

  • Difficulty urinating due to prostate gland enlargement.

Patients are advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by fever, medical advice should be sought.

In the event of an accidental overdose, immediate medical assistance should be obtained, or contact with a Poison Control Center is recommended.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, and it is crucial not to exceed the recommended dosage. A persistent cough may indicate a serious underlying condition; therefore, if a cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, patients are advised to consult a healthcare professional.

This product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks following the cessation of such medication. Patients uncertain about whether their prescription contains an MAOI should seek guidance from a doctor or pharmacist prior to use.

Before using this product, patients should consult a healthcare provider if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, especially if the cough is accompanied by excessive phlegm. Additionally, individuals with high blood pressure, heart disease, thyroid disease, diabetes, or difficulty urinating due to prostate enlargement should also seek medical advice.

Patients are advised to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Furthermore, if symptoms do not improve within seven days or are accompanied by fever, medical consultation is recommended.

Lastly, individuals taking sedatives or tranquilizers should consult a healthcare professional before using this product to avoid potential interactions.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this product while taking MAOIs or for a period of two weeks following the discontinuation of an MAOI. It is essential for patients to consult with a healthcare professional if they are uncertain whether their prescription medication contains an MAOI.

Additionally, caution is advised when considering the use of this product in conjunction with sedatives or tranquilizers. Patients are encouraged to seek medical advice prior to use if they are currently taking these types of medications to ensure safety and appropriate management of potential interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Biocotron (dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Biocotron.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 1/2 teaspoonful (2.5 mL) every 4 hours. For children under 6 years of age, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age considerations, dosage adjustments, safety concerns, or special precautions for this population. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, taking into account individual patient factors and overall health status. Monitoring for efficacy and safety is advised, as the absence of specific data does not preclude the need for careful assessment in elderly individuals.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is limited information available regarding the excretion of this drug in human breast milk and 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, monitoring, or precautions for patients with renal impairment. Healthcare professionals should consider the lack of guidance when prescribing to patients with reduced kidney function. Regular assessment of renal function may be warranted in these patients, although specific recommendations are not provided.

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

Overdosage of the medication can lead to serious health consequences. It is imperative that healthcare professionals adhere strictly to the recommended dosage guidelines to mitigate the risk of overdosage.

In the event of suspected overdosage, immediate medical attention should be sought. Symptoms of overdosage may vary depending on the specific medication involved, but common manifestations can include severe adverse reactions that necessitate prompt intervention.

Management of overdosage typically involves supportive care and symptomatic treatment. Healthcare providers should monitor the patient closely and implement appropriate measures based on the clinical presentation. In cases where specific antidotes are available, they should be administered as indicated.

It is crucial for healthcare professionals to educate patients about the importance of adhering to prescribed dosages and to provide guidance on what to do in the event of an overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a healthcare professional prior to 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 this medication out of the reach of children to prevent accidental ingestion. It is important for patients to understand the potential risks associated with overdose. In the event of an accidental overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. This information is crucial for ensuring patient safety and promoting responsible use of the medication.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of every 4 hours, not to exceed 6 doses within a 24-hour period unless directed otherwise by a physician. Clinicians should advise patients to keep the medication out of the reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an accidental overdose. Additionally, patients who are pregnant or breastfeeding should consult a doctor prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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