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Biogtuss

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This product has been discontinued

Active ingredients
  • Guaifenesin 300 mg/5 mL
  • Dextromethorphan Hydrobromide 15 mg/5 mL
  • Phenylephrine Hydrochloride 15 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 2009
Label revision date
December 20, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 300 mg/5 mL
  • Dextromethorphan Hydrobromide 15 mg/5 mL
  • Phenylephrine Hydrochloride 15 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 2009
Label revision date
December 20, 2024
Manufacturer
Advanced Generic Corporation
Registration number
M012
NDC root
45737-205
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

BioGtuss is a medication that contains 17 mg of phenylalanine (an amino acid important for protein synthesis) per 5 mL (one teaspoonful dose). While the specific uses of BioGtuss are not detailed, it is important to be aware that it may not be suitable for individuals with phenylketonuria, a condition that affects the metabolism of phenylalanine. Always consult with a healthcare professional for guidance on whether this medication is appropriate for you.

Uses

It seems 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 guidance.

Dosage and Administration

When using this medication, it's important to follow the correct dosage to ensure safety and effectiveness. If you are an adult or a child aged 12 years and older, you should take 1 teaspoonful (5 mL) every 4 hours. However, make sure not to exceed 6 doses within a 24-hour period.

For children aged 6 to under 12 years, the recommended dose is 1/2 teaspoonful (2.5 mL) every 4 hours, also not exceeding 6 doses in a day. If your child is under 6 years old, it's best to consult a doctor before giving them this medication to determine the appropriate course of action. Always follow these guidelines to ensure safe use.

What to Avoid

You should avoid using this medication if you have certain health conditions. Specifically, do not use it for a persistent cough related to smoking, asthma, chronic bronchitis, or emphysema, especially if accompanied by excessive mucus, unless your doctor advises otherwise. It's also important not to use this medication if you have chronic pulmonary disease, shortness of breath, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate, unless directed by a healthcare professional.

Additionally, if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, or Parkinson’s disease, you should not use this medication, nor for two weeks after stopping the MAOI. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist before taking this product.

Side Effects

It's important to be aware of potential side effects when using this medication. You should not exceed the recommended dosage, as doing so can lead to complications. A persistent cough lasting more than a week, especially if it comes back frequently or is accompanied by a fever, rash, or ongoing headache, may indicate a serious condition, so it's best to consult your doctor in such cases.

Additionally, this medication may cause or worsen constipation. If you experience nervousness, dizziness, or trouble sleeping, you should stop using the medication and speak with your doctor. If your symptoms do not improve within seven days or are accompanied by a fever, it's advisable to seek medical advice.

Warnings and Precautions

It's important to follow the recommended dosage for this medication, as exceeding it can lead to serious issues. If you develop a persistent cough that lasts more than a week, keeps coming back, or is accompanied by a fever, rash, or a lasting headache, you should consult your doctor right away, as this could indicate a more serious condition.

Be aware that this medication may cause or worsen constipation. If you experience nervousness, dizziness, or sleeplessness, stop using the medication and reach out to your doctor for guidance. Additionally, if your symptoms do not improve within seven days or if they are accompanied by a fever, it's essential to seek medical advice.

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 whether an overdose has occurred, contact a healthcare professional or poison control for guidance.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

When it comes to 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 to ensure it's safe and appropriate for their age.

Always remember to adhere to these guidelines to help keep your child safe and healthy. If you have any questions or concerns about the medication, don’t hesitate to reach out to your healthcare provider for advice.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that 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 may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to be aware of potential interactions with other medications you may be taking. If you are currently using a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, psychiatric conditions, or Parkinson’s disease, you should not take this product. Additionally, you should wait at least two weeks after stopping an MAOI before using this product.

Always consult with your healthcare provider or pharmacist if you're unsure whether your current medications include an MAOI. This conversation is crucial to ensure your safety and the effectiveness of your treatments.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally between 15° and 30°C (59° and 86°F). This temperature range helps maintain the product's integrity. Before using, always check that the seal under the cap or the cello-band over the cap is intact. If you find that the seal is torn, broken, or missing, do not use the product, as this could compromise its safety and effectiveness.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe for use.

Additional Information

You should take this medication orally. For adults and children aged 12 and over, the recommended dose is 1 teaspoonful (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 administering the medication.

FAQ

What is BioGtuss?

BioGtuss is a medication that contains 17 mg of Phenylalanine per 5 mL (one teaspoonful dose).

How should I store BioGtuss?

Store BioGtuss at room temperature between 15°- 30°C (59° - 86°F).

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

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

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

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

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

Children aged 6 to under 12 years should take 1/2 teaspoonful (2.5 mL) every 4 hours.

What should I do if my child is under 6 years old?

If your child is under 6 years of age, you should ask a doctor before administering BioGtuss.

Are there any contraindications for using BioGtuss?

Yes, do not use BioGtuss if you have certain conditions such as heart disease, high blood pressure, diabetes, or if you are taking a monoamine oxidase inhibitor (MAOI).

What should I do if I experience nervousness or dizziness while using BioGtuss?

If you experience nervousness, dizziness, or sleeplessness, discontinue use and consult a doctor.

Can I use BioGtuss if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using BioGtuss.

What should I do if my cough persists for more than a week?

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

Packaging Info

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

Packaging configurations for Biogtuss.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

BioGtussLabel is a pharmaceutical product formulated for therapeutic use. It is characterized by its specific chemical composition and intended dosage form. The product's molecular weight and chemical formula are integral to its pharmacological properties. The formulation includes a selection of inactive ingredients that contribute to its stability and efficacy. The appearance of BioGtussLabel is consistent with industry standards for its category, ensuring proper identification and handling in clinical settings.

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 this information when evaluating treatment options for their patients.

Dosage and Administration

Adults and children aged 12 years and older are advised to take 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 doses within a 24-hour period. For children aged 6 to under 12 years, the recommended dosage is 1/2 teaspoonful (2.5 mL) every 4 hours, also not to exceed 6 doses in a 24-hour timeframe. For children under 6 years of age, it is recommended to consult a physician for appropriate dosing guidance.

Healthcare professionals should ensure that patients are aware of the maximum dosage limits and the importance of adhering to the specified intervals to avoid potential overdose.

Contraindications

Use of this product is contraindicated in the following situations:

  • Persistent cough associated with smoking, asthma, chronic bronchitis, emphysema, or when accompanied by excessive phlegm, unless directed by a healthcare professional.

  • Chronic pulmonary disease or shortness of breath, particularly in children taking other medications, unless directed by a healthcare professional.

  • Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI. Patients should consult a healthcare professional if uncertain about MAOI use.

  • Heart disease.

  • High blood pressure.

  • Thyroid disease.

  • Diabetes.

  • Difficulty in urination due to prostate gland enlargement, unless directed by a healthcare professional.

Warnings and Precautions

Exceeding the recommended dosage is contraindicated and may lead to adverse effects. Healthcare professionals should advise patients to adhere strictly to the prescribed dosage to ensure safety and efficacy.

A persistent cough may indicate a serious underlying condition. Patients should be instructed to seek medical consultation if their cough persists for more than one week, recurs frequently, or is accompanied by additional symptoms such as fever, rash, or a persistent headache.

This medication may cause or exacerbate constipation. Monitoring for gastrointestinal symptoms is advised, and patients should be counseled on appropriate dietary and lifestyle modifications to mitigate this risk.

In the event that patients experience nervousness, dizziness, or sleeplessness, they should discontinue use immediately and consult a healthcare professional for further evaluation and guidance.

If symptoms do not show improvement within seven days or are accompanied by fever, it is imperative that patients seek medical advice. Regular monitoring of symptoms and timely intervention are essential for patient safety.

Side Effects

Patients should be aware of several important warnings associated with the use of this medication. It is crucial not to exceed the recommended dosage, as doing so may lead to adverse effects. A persistent cough may indicate a serious underlying condition; therefore, if a cough persists for more than a week, recurs, or is accompanied by fever, rash, or a persistent headache, patients are advised to consult a healthcare professional.

Additionally, this medication may cause or exacerbate constipation. Patients experiencing nervousness, dizziness, or sleeplessness should discontinue use and seek medical advice. If symptoms do not improve within 7 days or are accompanied by fever, it is recommended that patients consult a doctor for further evaluation.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson’s disease. Patients should avoid taking this product while on MAOIs and for a period of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with their healthcare provider or pharmacist if they are uncertain about whether their current prescription includes an MAOI. This precaution is critical to prevent potential adverse interactions that may arise from the combination of these medications.

Packaging & NDC

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

Packaging configurations for Biogtuss.
Details

Pediatric Use

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

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. 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

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 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 clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

Overdosage

Exceeding the recommended dosage of the medication may lead to serious adverse effects. Healthcare professionals are advised to strictly adhere to the prescribed dosage guidelines to mitigate the risk of overdosage.

In the event of suspected overdosage, it is crucial to monitor the patient closely for any potential symptoms that may arise. Symptoms of overdosage can vary depending on the specific medication involved and may include, but are not limited to, severe drowsiness, confusion, respiratory depression, or other significant neurological effects.

Management of overdosage should be initiated promptly. Healthcare providers should assess the patient's clinical status and consider supportive care measures. This may involve the administration of activated charcoal if the ingestion occurred within a suitable timeframe and the patient is alert and able to protect their airway. In cases of severe overdosage, advanced medical interventions may be necessary, including the use of antidotes if available and appropriate.

It is essential for healthcare professionals to report any cases of overdosage to the relevant authorities and to consult the product's prescribing information for specific management recommendations tailored to the medication in question.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. There are no specific non-teratogenic effects or nonclinical toxicology details available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include dizziness, drowsiness, nausea, vomiting, and allergic reactions such as rash, itching, and swelling.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young individuals.

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°C (59° to 86°F).

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

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 1 teaspoonful (5 mL) every 4 hours. For children aged 6 to under 12 years, the dosage is 1/2 teaspoonful (2.5 mL) every 4 hours. For children under 6 years of age, it is advised to consult a doctor regarding appropriate dosing.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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