Biocof

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritations, which may occur due to the common cold or inhaled irritants. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby making coughs more productive. The drug also provides temporary relief from nasal congestion related to the common cold.

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

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 1 teaspoonful (5 mL) orally every 4 hours. It is essential not to exceed more than 6 doses within a 24-hour period. For children under 12 years of age, consultation with a physician is recommended prior to administration.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, as well as for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult their healthcare provider or pharmacist if they are uncertain about the presence of an MAOI in their current medication regimen.

Warnings and Precautions

It is imperative that healthcare professionals advise patients to consult a physician 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, a cough with excessive phlegm (mucus), or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Additionally, patients should be cautioned to seek guidance from a doctor or pharmacist before using this product in conjunction with any other nasal decongestants or stimulants. It is crucial that patients adhere strictly to the recommended dosage and not exceed the directed amount during use.

Patients must be instructed to discontinue use and consult a healthcare professional if they experience symptoms such as nervousness, dizziness, or sleeplessness; if symptoms do not improve within 7 days; or if they are accompanied by fever. Furthermore, if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, patients should seek medical attention, as these may indicate a serious underlying condition.

In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients using this medication should be aware of potential adverse reactions. Serious adverse reactions may include symptoms such as nervousness, dizziness, or sleeplessness. If these symptoms do not improve within 7 days or are accompanied by fever, patients are advised to stop use and consult a healthcare professional. Additionally, if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, these may indicate a serious condition, and medical advice should be sought.

Common adverse reactions may occur in patients with pre-existing conditions. It is recommended that individuals consult a doctor before using this medication if they have heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to an enlarged prostate gland, a cough with excessive phlegm, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on MAOIs or for a period of two weeks following the discontinuation of an MAOI. The combination may result in serious interactions that could pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified for this medication. Therefore, routine monitoring or dosage adjustments are not indicated beyond the contraindication with MAOIs.

Packaging & NDC

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

Pediatric Use

Children under 12 years of age should consult a physician before use. For adults and children aged 12 years and over, the recommended dosage is 1 teaspoonful (5 mL) every 4 hours. It is important to keep this medication out of the reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center.

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 associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 drug 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 may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies as needed.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health 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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, sleeplessness, rash, and persistent headache. Such reactions may occur in patients using the product.

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 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 its integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F) and protected from light to prevent degradation. After opening, the product should be discarded to ensure safety and efficacy. Additionally, it is essential to keep the product out of the reach of children to prevent accidental ingestion.

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 under 12 years of age, it is advised to consult a physician for appropriate dosing guidance. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

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