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Biocotron-D

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This product has been discontinued

Active ingredients
  • Guaifenesin 200 mg/5 mL
  • Dextromethorphan Hydrobromide 10 mg/5 mL
  • Phenylephrine Hydrochloride 5 mg/5 mL
Other brand names
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
December 20, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 200 mg/5 mL
  • Dextromethorphan Hydrobromide 10 mg/5 mL
  • Phenylephrine Hydrochloride 5 mg/5 mL
Other brand names
Dosage form
Suspension/ Drops
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 2013
Label revision date
December 20, 2024
Manufacturer
Advanced Generic Corporation
Registration number
M012
NDC root
45737-208
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

You may be looking for information about a medication that contains sodium, specifically 6 mg per teaspoonful (5 mL). While the specific name and general description of the drug are not provided, it is important to note that sodium is often included in various formulations for different therapeutic purposes.

If you have any specific questions about how this medication works or its uses, please consult a healthcare professional for more detailed information tailored to your needs.

Uses

It appears that there are no specific uses or indications provided for this medication. Additionally, there are no mentions of teratogenic effects (which refer to substances that can cause developmental abnormalities in a fetus) or nonteratogenic effects (which do not affect fetal development). If you have any questions or need further information about this medication, please consult your healthcare provider for personalized advice.

Dosage and Administration

When using this medication, it's important to follow the dosage instructions carefully to ensure safety and effectiveness. For adults and children aged 12 years and older, you should take 2 teaspoons every 4 hours, but remember not to exceed 3 doses in a 24-hour period. If you're giving this medication to children aged 6 to under 12 years, the appropriate dose is 1 teaspoon every 4 hours. For younger children, specifically those aged 2 to under 6 years, you should administer 1/2 teaspoon every 4 hours.

If your child is under 2 years old, it's best to consult a doctor before giving them this medication. Always keep track of how many doses you've given to avoid taking more than the recommended amount within a day.

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 treating depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, you should not use this medication for at least two weeks after stopping an MAOI. This is important to prevent serious interactions that could affect your health. Always consult with your healthcare provider if you have any questions about your medications.

Side Effects

It's important to be aware of potential side effects when using this medication. You should consult your doctor before using it if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate, or a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, if you are taking any other nasal decongestants or stimulants, it's wise to check with your doctor or pharmacist first.

While using this product, make sure to follow the directions carefully and do not exceed the recommended dosage. This will help minimize the risk of adverse reactions.

Warnings and Precautions

Before using this product, it's important to consult your doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate, or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, if you are taking any other nasal decongestants or stimulants, check with your doctor or pharmacist first. Always follow the dosage instructions carefully and do not exceed the recommended amount.

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression or other psychiatric 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 healthcare provider.

If you experience nervousness, dizziness, sleeplessness, or if your symptoms do not improve within 7 days or are accompanied by a fever, stop using the product and contact your doctor. Also, if your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, seek medical advice. In the event of an accidental overdose, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs or symptoms of an overdose for this medication, general signs may include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. It's always better to be cautious and get professional advice if you think you or someone else may have taken too much of a medication.

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 giving medication to your child, it's important to follow the correct dosage based on their age. For children aged 6 to under 12 years, the recommended dose is 1 teaspoon every 4 hours. If your child is between 2 and under 6 years old, they should receive 1/2 teaspoon every 4 hours. For children under 2 years of age, you should consult a doctor before administering any medication.

Always keep medications out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help or contact a Poison Control Center immediately. Your child's safety is the top priority, so make sure to follow these guidelines closely.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

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.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and appropriate for your kidney health.

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 liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are currently taking any other nasal decongestants or stimulants. Certain medications, like monoamine oxidase inhibitors (MAOIs), which are used to treat depression and other conditions, can interact negatively with this product. You should not use this medication if you are taking an MAOI or have taken one in the past two weeks. If you're unsure whether your prescription includes an MAOI, please consult with a healthcare professional. Always prioritize your safety by discussing all medications and treatments with your healthcare provider.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 15-30 degrees Celsius (59-86 degrees Fahrenheit). This temperature range helps maintain its effectiveness.

When handling the product, be sure to check the seal under the cap or the cello-band over the cap. If you find that the seal is torn, broken, or missing, do not use the product, as this could compromise its safety and effectiveness. Always prioritize these guidelines to ensure safe and proper use.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is the recommended storage temperature for this drug?

You should store this drug at room temperature between 15-30 degrees C (59-86 degrees F).

What should I do if the seal under the cap is broken?

Do not use the drug if the seal under the cap or the cello-band over the cap is torn, broken, or missing.

What is the maximum number of doses I can take in a 24-hour period?

You should not take more than 3 doses in any 24-hour period.

What is the dosage for adults and children 12 years and older?

Adults and children 12 years of age and over should take 2 teaspoons every 4 hours.

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

Children aged 6 to under 12 years should take 1 teaspoon every 4 hours.

What is the dosage for children aged 2 to under 6 years?

Children aged 2 to under 6 years should take 1/2 teaspoon every 4 hours.

What should I do if my child is under 2 years of age?

If your child is under 2 years of age, you should ask a doctor for advice.

Are there any contraindications for using this drug?

Do not use this drug if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do if I experience nervousness, dizziness, or sleeplessness?

Stop using the drug and ask a doctor if you experience these symptoms, especially if they do not improve within 7 days or are accompanied by fever.

What should I do in case of accidental overdose?

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Can I use this drug if I am pregnant or breastfeeding?

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

What precautions should I take if I have certain health conditions?

Ask a doctor before use if you have heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland.

Packaging Info

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

Packaging configurations for Biocotron-D.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Biocotron is presented in the form of an image file, specifically in JPEG format. The reference image for Biocotron is labeled as biocotron.jpg.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the absence of these effects when evaluating treatment options for their patients.

Dosage and Administration

The recommended dosage for the medication varies by age group and should not exceed three doses within a 24-hour period.

For adults and children aged 12 years and older, the dosage is 2 teaspoons administered every 4 hours. For children aged 6 to under 12 years, the appropriate dosage is 1 teaspoon every 4 hours. In children aged 2 to under 6 years, the dosage is 1/2 teaspoon every 4 hours. For children under 2 years of age, it is advised to consult a physician before administration.

Healthcare professionals should ensure that patients adhere to the specified dosing intervals and do not exceed the maximum daily limit to avoid potential adverse effects.

Contraindications

Use 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 2 weeks following the discontinuation of an MAOI due to the potential for serious interactions.

Warnings and Precautions

Patients should consult a healthcare professional prior to using this product if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, it is advisable to seek guidance from a doctor or pharmacist if the patient is currently taking any other nasal decongestants or stimulants. It is imperative to adhere strictly to the recommended dosage and not exceed the directed amount while using this product.

This product is contraindicated in individuals who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional disorders, or Parkinson's disease. Use of this product is also prohibited for a period of two weeks following the cessation of an MAOI. If there is uncertainty regarding the presence of an MAOI in any current prescription, it is essential to consult a healthcare professional before use.

Patients should discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness, particularly if these symptoms persist beyond seven days or are accompanied by fever. Furthermore, if a cough lasts longer than seven days, recurs, or is associated with fever, rash, or a persistent headache, medical advice should be sought, as these may indicate a serious underlying condition.

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

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is advised that individuals consult a healthcare professional prior to use if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Additionally, those experiencing a chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice before using this product.

Furthermore, patients are encouraged to inform their doctor or pharmacist if they are currently taking any other nasal decongestants or stimulants, as interactions may occur. It is crucial to adhere to the recommended dosage and not exceed the directed amount while using this product to minimize the risk of adverse reactions.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently taking any other nasal decongestants or stimulants, as this may lead to increased risk of adverse effects.

The use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain 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 discontinuation of an MAOI. Patients uncertain about the presence of an MAOI in their current medication regimen are advised to seek guidance from a healthcare provider or pharmacist before initiating treatment with this product.

Packaging & NDC

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

Packaging configurations for Biocotron-D.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 1 teaspoon every 4 hours. For children aged 2 to under 6 years, the recommended dosage is 1/2 teaspoon every 4 hours. It is advised that caregivers consult a doctor for children under 2 years of age regarding appropriate dosing.

Healthcare professionals should emphasize the importance of keeping the medication out of the reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data 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 the lack of information necessitates careful clinical judgment and monitoring.

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 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

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, the following management procedures are recommended:

  1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Consultation: Consider consulting a poison control center or a medical toxicologist for guidance on specific interventions and treatments that may be appropriate based on the substance involved.

  4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these general management strategies in the event of an overdose, even in the absence of specific overdosage information.

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

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. In the event of an accidental overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center.

Patients must be informed not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain drugs used for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, they should be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription includes an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to use.

Healthcare providers should also instruct patients to stop using the medication and consult a doctor if they experience nervousness, dizziness, or sleeplessness that does not improve within seven days, or if these symptoms are accompanied by fever. Furthermore, patients should be advised to seek medical advice if a cough persists for more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at room temperature, specifically within the range of 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit).

Healthcare professionals are advised to ensure that the seal under the cap, as well as any cello-band over the cap, remains intact. The product should not be used if these seals are torn, broken, or missing, as this may compromise the integrity and safety of the product.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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