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Bio-S-Pres

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This product has been discontinued

Active ingredients
  • Guaifenesin 50 mg/1 mL
  • Dextromethorphan Hydrobromide 5 mg/1 mL
  • Phenylephrine Hydrochloride 2.5 mg/1 mL
Other brand names
Dosage form
Solution/ 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 50 mg/1 mL
  • Dextromethorphan Hydrobromide 5 mg/1 mL
  • Phenylephrine Hydrochloride 2.5 mg/1 mL
Other brand names
Dosage form
Solution/ 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
45737-230
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 designed to help loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to drain your bronchial tubes and have more productive coughs. It temporarily relieves nasal congestion caused by hay fever or other upper respiratory allergies (allergic rhinitis) and can also soothe coughs resulting from minor throat and bronchial irritation, which may occur with the common cold.

By addressing these symptoms, this medication aims to improve your comfort and ease your breathing during times of respiratory discomfort.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. This action helps drain your bronchial tubes, making your coughs more productive.

Additionally, it provides temporary relief from nasal congestion caused by hay fever or other upper respiratory allergies (known as allergic rhinitis). It can also soothe coughs that may arise from minor throat and bronchial irritation, which often happens with the common cold.

Dosage and Administration

When using this medication, it's important to follow the directions carefully to ensure safety and effectiveness. You should not take more than 6 doses within a 24-hour period. Always measure your dose using the device provided with the medication, as using any other measuring device could lead to incorrect dosing.

For children aged 2 to under 6 years, the recommended dose is 1 mL every 4 hours. If your child is under 2 years old, it's crucial to consult a doctor before administering this medication. This will help ensure that your child receives the appropriate care and dosage.

What to Avoid

You should avoid using this product if you have a persistent or chronic cough, such as one caused by asthma, or if your cough is accompanied by excessive mucus, unless your doctor specifically advises otherwise. It's also important not to give this product to children who are taking certain prescription medications called Monoaminooxidase Inhibitors (MAOIs), which are used for depression or other psychiatric conditions, or for two weeks after stopping these medications. If you're unsure whether your child's medication contains an MAOI, please consult a doctor or pharmacist.

Additionally, do not administer this product to children with heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a healthcare professional. Always prioritize safety and seek guidance from a medical expert if you have any questions or concerns.

Side Effects

It's important to be aware of potential side effects when using this medication. You should not exceed the recommended dosage. If you experience nervousness, dizziness, or sleeplessness, it's best to stop using the medication and consult your doctor. Additionally, if your symptoms do not improve within 7 days or if you develop a fever, please seek medical advice.

Warnings and Precautions

It's important to follow the recommended dosage when using this product. If you experience nervousness, dizziness, or sleeplessness, stop using it and consult your doctor. Additionally, if your symptoms do not improve within 7 days or if you develop a fever, seek medical advice.

You should not use this product for a persistent or chronic cough, especially if it is related to asthma or accompanied by excessive mucus, unless directed by a doctor. Avoid giving this product to children who are taking certain prescription medications called Monoaminooxidase Inhibitors (MAOIs) or have conditions like heart disease, high blood pressure, thyroid disease, or diabetes, unless advised by a healthcare professional.

If you have a persistent cough that may indicate a serious condition, or if your cough lasts more than a week, recurs, or is accompanied by fever, rash, or a persistent headache, stop using the product and contact your doctor. In the event 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, or if you are unsure whether an overdose has occurred, seek immediate medical help. Always prioritize your safety and well-being by adhering to the recommended dosage.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. You should consult your doctor before using it, as there may be potential risks to your fetus. Use of this product should be avoided unless specifically directed by a healthcare provider.

If you do use this product, be aware that dosage adjustments may be necessary, so it's crucial to seek guidance from a healthcare professional. Additionally, monitor yourself for any adverse effects during pregnancy and report them to your healthcare provider promptly. Your health and the health of your baby are the top priority.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that the ingredients may pass into your breast milk, which could pose risks to your infant. Therefore, exercise caution when considering this product while nursing, as it may affect both your milk production and your baby's health. Always prioritize open communication with your healthcare provider to ensure the best outcomes for you and your child.

Pediatric Use

It's important to be cautious when giving this product to children. You should not give it to your child if they have heart disease, high blood pressure, thyroid disease, or diabetes unless a doctor has specifically advised you to do so. For children aged 2 to under 6 years, the recommended dosage is 1 mL every 4 hours. If your child is under 2 years old, you should consult a doctor before use.

Additionally, avoid using this product if your child is currently taking a prescription Monoaminooxidase Inhibitor (MAOI), or for two weeks after stopping an MAOI. If you're unsure whether your child's medication includes an MAOI, it's best to check with a doctor or pharmacist before administering this product.

Geriatric Use

When it comes to using this medication, there are no specific recommendations or dosage adjustments for older adults. This means that the standard dosage applies to you, and there are no additional safety concerns or special precautions noted for elderly patients.

It's always a good idea to discuss any medications with your healthcare provider, especially if you have other health conditions or are taking multiple medications. They can help ensure that the treatment is safe and effective for your individual needs.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to be adjusted based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific condition. They can help monitor your kidney health and make any necessary changes to your medications.

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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to be cautious when giving this product to children, especially if they are taking certain prescription medications known as Monoaminooxidase Inhibitors (MAOIs). These are drugs often prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. You should not use this product in a child who is currently taking an MAOI or for two weeks after they have stopped taking it. If you're unsure whether your child's medication includes an MAOI, please consult with a doctor or pharmacist before administering this product.

Always discuss any medications or tests with your healthcare provider to ensure safety and avoid potential interactions. Your provider can help you understand the risks and make informed decisions about your child's health.

Storage and Handling

To ensure the best quality and safety of your product, store it at a temperature between 20°C and 25°C (68°F to 77°F). It's important to keep the product protected from light to maintain its effectiveness. When you're not using the bottle, make sure to keep it tightly closed to prevent contamination. Remember to discard the product after opening to ensure your safety and the integrity of the contents.

Additional Information

You should take this medication orally. It's important to keep it out of the reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center for assistance.

FAQ

What is the main use of this product?

This product helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes, making coughs more productive.

Can this product relieve nasal congestion?

Yes, it temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis).

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

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

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

Consult a doctor before giving this product to a child under 2 years of age.

Are there any contraindications for using this product?

Do not use this product for persistent coughs, in children taking Monoaminooxidase Inhibitors (MAOIs), or in children with heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.

What should I do if my symptoms do not improve?

If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

Is this product safe to use during pregnancy?

The safety of this product during pregnancy has not been established; consult a doctor if pregnant or planning to become pregnant.

What precautions should nursing mothers take?

Nursing mothers should consult a doctor before using this product due to the potential for excretion in breast milk.

What should I do in case of accidental overdose?

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

How should I store this product?

Store at 20°C to 25°C (68°F to 77°F), protect from light, and keep the bottle tightly closed when not in use.

Packaging Info

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

Packaging configurations for Bio-S-Pres.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product identified by SPL code 34089-3 is known as biospres. It is presented in a media type of image/jpeg, with a reference image titled BioSPresDXDrops.jpg.

Uses and Indications

This drug is indicated for the relief of symptoms associated with respiratory conditions. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating drainage of the bronchial tubes and enhancing the productivity of coughs. Additionally, it temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis) and alleviates cough resulting from minor throat and bronchial irritation, which may occur with the common cold.

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

Dosage and Administration

The maximum recommended dosage should not exceed 6 doses within a 24-hour period. It is imperative that the dosage is measured using the device provided with the medication; the use of any other measuring device is not advised.

For children aged 2 to under 6 years, the recommended dosage is 1 mL administered every 4 hours as needed. For children under 2 years of age, it is essential to consult a healthcare professional prior to administration to determine the appropriate dosage.

Contraindications

Use of this product is contraindicated in the following situations:

  • Persistent or chronic cough, such as that associated with asthma, or when the cough is accompanied by excessive phlegm (mucus), unless directed by a healthcare professional.

  • In children currently taking a prescription Monoaminooxidase Inhibitor (MAOI) or within two weeks of discontinuing such medication. If there is uncertainty regarding the presence of an MAOI in a child's prescription, consultation with a healthcare provider is advised.

  • In children with a history of heart disease, high blood pressure, thyroid disease, or diabetes, unless specifically directed by a healthcare professional.

Warnings and Precautions

Patients should adhere strictly to the recommended dosage of this product. Exceeding the advised dosage may lead to adverse effects. In the event of nervousness, dizziness, or sleeplessness, it is imperative to discontinue use and consult a healthcare professional. Should symptoms fail to improve within 7 days or if they are accompanied by fever, medical advice should be sought promptly.

This product is not intended for use in cases of persistent or chronic cough, such as those associated with asthma, or if the cough is accompanied by excessive phlegm (mucus), unless specifically directed by a healthcare provider. Additionally, it is contraindicated for use in children who are currently taking a prescription Monoaminooxidase Inhibitor (MAOI) or have taken one within the past two weeks. If there is uncertainty regarding whether a child's prescription includes an MAOI, consultation with a doctor or pharmacist is essential prior to administration. Furthermore, this product should not be given to children with heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a healthcare professional.

Patients should discontinue use and seek medical advice if a persistent cough may indicate a serious condition. If a cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, it is crucial to consult a healthcare provider.

In the case of an accidental overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is crucial not to exceed the recommended dosage, as doing so may lead to serious side effects.

In clinical observations, participants have reported experiencing nervousness, dizziness, or sleeplessness. Should any of these symptoms occur, it is advised to discontinue use immediately and consult a healthcare professional. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, patients should seek medical advice promptly.

These warnings highlight the importance of monitoring for adverse reactions and ensuring appropriate medical consultation when necessary.

Drug Interactions

The concomitant use of this product with Monoaminooxidase Inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson's disease. It is essential to avoid administering this product to a child who is currently taking an MAOI or has taken one within the past two weeks.

If there is uncertainty regarding whether a child's prescription medication contains an MAOI, it is advised to consult a healthcare professional, such as a doctor or pharmacist, prior to the use of this product. This precaution is critical to prevent potential adverse effects associated with the interaction.

Packaging & NDC

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

Packaging configurations for Bio-S-Pres.
Details

Pediatric Use

Pediatric patients with heart disease, high blood pressure, thyroid disease, or diabetes should not receive this product unless specifically directed by a healthcare professional.

For children aged 2 to under 6 years, the recommended dosage is 1 mL every 4 hours. In children under 2 years of age, consultation with a doctor is advised prior to administration.

This product is contraindicated in pediatric patients who are currently taking a prescription Monoaminooxidase Inhibitor (MAOI) or within two weeks of discontinuing an MAOI. If there is uncertainty regarding the presence of an MAOI in a child's prescription medication, it is essential to consult a doctor or pharmacist before administering this product.

Geriatric Use

Elderly patients may not require specific dosage adjustments or special precautions when using this medication, as there are no recommendations or safety concerns outlined in the provided drug insert. However, healthcare providers should remain vigilant in monitoring the overall health status of geriatric patients, considering the potential for altered pharmacokinetics and increased sensitivity to medications in this population. Regular assessment and individualized treatment plans are advisable to ensure optimal therapeutic outcomes.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. There may be potential risks to the fetus; therefore, use should be avoided unless directed by a healthcare professional.

Dosage adjustments may be necessary for pregnant patients, and it is essential to seek guidance from a healthcare provider regarding appropriate dosing. Additionally, monitoring for any adverse effects during pregnancy is crucial, and any such effects should be reported to a healthcare provider promptly.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when administering this product to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 can lead to serious health consequences. It is imperative that healthcare professionals adhere strictly 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 a range of physiological and psychological effects.

Management of overdosage should be initiated promptly. Healthcare professionals are advised to assess the patient's condition and provide supportive care as necessary. This may include symptomatic treatment and monitoring of vital signs. In cases where the overdosage is significant, further medical intervention may be required, including the consideration of activated charcoal if appropriate and within the recommended time frame post-ingestion.

It is essential for healthcare providers to remain vigilant and to educate patients about the importance of adhering to prescribed dosages to prevent the occurrence of overdosage.

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 question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product 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 or contact a Poison Control Center immediately.

Patients should be informed that this product is not intended for use in cases of persistent or chronic cough, such as those associated with asthma, or if the cough is accompanied by excessive phlegm (mucus), unless directed by a healthcare professional. It is crucial to emphasize that this product should not be administered to a child who is currently taking a prescription Monoaminooxidase Inhibitor (MAOI) or within two weeks of stopping such medication. If patients are uncertain whether their child's prescription includes an MAOI, they should be encouraged to consult a doctor or pharmacist prior to use.

Additionally, healthcare providers should caution against giving this product to children with heart disease, high blood pressure, thyroid disease, or diabetes unless specifically directed by a healthcare professional. Patients should be advised to discontinue use and consult a doctor if a persistent cough may indicate a serious condition. Furthermore, if a cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, patients should seek medical advice promptly.

Storage and Handling

The product is supplied in a container that must be stored at a temperature range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to maintain its integrity. The bottle should be kept tightly closed when not in use to prevent contamination and degradation. Additionally, any unused product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the medication out of the reach of children. In the event of an accidental overdose, patients are instructed to seek medical assistance or contact a Poison Control Center immediately.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Bio-S-Pres, 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 Bio-S-Pres, 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

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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.