Father Johns Medicine

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to a cold or inhaled irritants.

Limitations of Use: This medication is intended for symptomatic relief and does not address the underlying causes of cough. It is not recommended for use in patients with chronic cough or cough associated with smoking, asthma, or emphysema without consulting a healthcare professional.

Dosage and Administration

The medication should be shaken well before use to ensure proper mixing of the formulation.

For adults and children aged 12 years and older, the recommended dosage is 2 teaspoons every 4 hours, with a maximum limit of six doses within a 24-hour period.

For children aged 6 years to under 12 years, the appropriate dosage is 1 teaspoon every 4 hours, adhering to the same maximum of six doses in a 24-hour timeframe.

For children under 6 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or a poison control center should be contacted.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, the use of this product is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is any uncertainty regarding the presence of a MAOI in a patient's prescription, it is imperative to consult a healthcare professional prior to using this product.

In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a poison control center without delay.

No specific general precautions or laboratory tests have been provided in the insert; therefore, healthcare professionals should exercise clinical judgment and consider individual patient circumstances when advising on the use of this product.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. A significant warning is that it should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this product should not be taken for at least two weeks after discontinuing an MAOI. Patients are advised to consult a healthcare professional if there is any uncertainty regarding the presence of an MAOI in their current prescription regimen.

It is crucial for patients to adhere to these guidelines to avoid serious interactions and ensure their safety while using this product.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, certain psychiatric or emotional conditions, and Parkinson's disease. Patients should not take this product while on MAOIs or for a period 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 current medication regimen.

Packaging & NDC

Below are the non-prescription pack sizes of Father Johns Medicine (dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may be administered 2 teaspoons every 4 hours. For children aged 6 years to under 12 years, the recommended dosage is 1 teaspoon every 4 hours. In children under 6 years of age, it is advised to consult a doctor before administration.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of dextromethorphan hydrobromide during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for this medication in the context of pregnancy. Therefore, healthcare professionals should exercise caution when considering the use of dextromethorphan hydrobromide in women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is advisable to discuss the use of this medication with pregnant patients, considering the lack of available data.

Lactation

Lactating mothers should consult a health professional before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

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 these patients to ensure safety and efficacy.

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 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, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include dizziness, nausea, vomiting, somnolence, confusion, and hallucinations. Additional reactions noted are agitation, respiratory depression, increased blood pressure, and tachycardia. Skin rash and allergic reactions, including anaphylaxis, have also been documented.

Further, hepatotoxicity and serotonin syndrome have been reported. There is an indication of potential for abuse and dependence, as well as withdrawal symptoms occurring upon discontinuation after prolonged use.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a poison control center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in a configuration that requires careful handling. It is essential to shake well before use to ensure proper mixing of the contents. To maintain safety, the product should be kept out of reach of children. Additionally, it is important to discard the product after opening to prevent any potential risks associated with prolonged exposure to the environment.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the medication out of reach of children and to seek medical assistance or contact a poison control center immediately in the event of an overdose. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)