Biogtuss

Description

The drug biogtusstr is documented with an effective insert date of December 23, 2020. The insert contains a media reference for an image labeled "biogtusstr label," which is available in JPEG format.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with cough, the common cold, hay fever, or other upper respiratory allergies. It aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating drainage of the bronchial tubes. Additionally, it helps to relieve nasal congestion, clear stuffy noses, and clear nasal passageways by shrinking swollen membranes. The formulation also acts to calm the cough control center, making coughs more productive.

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

Dosage and Administration

For adults and children aged 12 years and over, the recommended dosage is 1 tablet every 4 hours, with a maximum limit of 4 tablets within a 24-hour period.

For children aged 6 to 12 years, the dosage is 1/2 tablet every 4 hours, not to exceed 3 tablets 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 about the importance of adhering to these dosage guidelines to avoid potential overdose.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional if the following conditions occur: nervousness, dizziness, or sleeplessness; symptoms accompanied by fever, rash, persistent headache, or excessive phlegm; or if cough and congestion do not improve within 7 days or are accompanied by fever or recurring symptoms.

Warnings and Precautions

Patients should adhere strictly to the recommended dosage of this product. Exceeding the advised dosage may lead to adverse effects.

This product is contraindicated for individuals currently taking Monoamine Oxidase Inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's Disease. It is also contraindicated for use within two weeks following the cessation of an MAOI. Healthcare professionals should be consulted if there is any uncertainty regarding the presence of an MAOI in a prescription medication.

Prior to using this product, it is essential for patients to consult a healthcare provider if they have any of the following conditions: heart disease, excessive phlegm (mucus), high blood pressure, diabetes, thyroid disease, difficulty urinating due to prostate gland enlargement, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

While using this product, patients must not exceed the directed dosage.

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

Patients are instructed to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus), medical advice should be sought. If cough and congestion do not improve within seven days, or if symptoms are accompanied by fever or tend to recur, patients should also contact their healthcare provider.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals with pre-existing conditions. It is crucial that patients do not exceed the recommended dosage and refrain from using this product if they are currently taking a Monoamine Oxidase Inhibitor (MAOI) or have taken one within the past two weeks, as this could lead to significant interactions.

Before using this product, patients should consult a healthcare professional if they have a history of heart disease, excessive phlegm (mucus), high blood pressure, diabetes, thyroid disease, difficulty urinating due to prostate enlargement, or persistent or chronic coughs associated with smoking, asthma, chronic bronchitis, or emphysema.

Patients are advised to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus), medical consultation is recommended. Cough and congestion that do not improve within seven days, or that are accompanied by fever or recurring symptoms, should also prompt a discussion with a healthcare provider.

Drug Interactions

The concomitant use of this product with Monoamine Oxidase Inhibitors (MAOIs) is contraindicated. MAOIs are a class of medications commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's Disease. Patients should not use this product while taking an MAOI or for a minimum of two weeks following the discontinuation of an MAOI. It is essential for patients to consult a healthcare professional if there is any uncertainty regarding the presence of an MAOI in their prescription medications.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to 12 years may be administered 1/2 tablet every 4 hours, with a maximum dosage not to exceed 3 tablets in a 24-hour period. For children under 6 years of age, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 adverse effects or changes in therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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

Exceeding the recommended dosage of this product may lead to serious health consequences. Healthcare professionals are advised to ensure that patients 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 for any potential symptoms that may arise. Symptoms of overdosage can vary depending on the specific product and the extent of the excess dosage.

Management of overdosage should involve immediate assessment and supportive care. Healthcare providers should be prepared to implement appropriate interventions based on the clinical presentation of the patient. It is essential to consult relevant medical guidelines and toxicology resources for specific management protocols tailored to the product in question.

In summary, adherence to the recommended dosage is imperative to prevent overdosage and its associated risks.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be made aware that if symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus), they should also seek medical advice. It is important to communicate that if cough and congestion do not improve within 7 days, or if they are accompanied by fever or if symptoms tend to recur, patients should contact their healthcare provider for further evaluation.

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. Additionally, the product should be discarded after opening to ensure safety and efficacy.

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 Biogtuss, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)