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Father Johns Medicine

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Active ingredient
Dextromethorphan Hydrobromide 10 mg/5 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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 2019
Label revision date
December 18, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dextromethorphan Hydrobromide 10 mg/5 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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 2019
Label revision date
December 18, 2023
Manufacturer
Oakhurst Company
Registration number
M012
NDC root
45728-444
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Father Johns Original is a medication designed to temporarily relieve cough caused by minor throat and bronchial irritation, which can occur due to a cold or inhaled irritants. It aims to provide comfort when you're experiencing these symptoms, helping you feel better during your recovery.

Uses

If you're dealing with a cough caused by minor irritation in your throat or bronchial tubes, such as from a cold or inhaled irritants, this medication can help. It works by temporarily relieving your cough, making it easier for you to go about your day without constant interruptions.

Remember, this relief is specifically for minor irritations, so if your symptoms persist or worsen, it's important to consult a healthcare professional for further advice.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. For adults and children aged 12 years and older, the recommended dose is 2 teaspoons every 4 hours. If you have children between the ages of 6 and under 12, they should take 1 teaspoon every 4 hours.

It's important to remember that you should not take more than six doses within a 24-hour period. If your child is under 6 years old, please consult a doctor for the appropriate dosage. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. If you suspect an overdose, seek medical help immediately or contact a poison control center for assistance.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always use it responsibly and follow any additional guidance provided by your healthcare professional.

Side Effects

It's important to be aware of certain warnings when considering this medication. You should not use it if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, you should wait at least two weeks after stopping an MAOI before starting this medication. If you're unsure whether your current prescription includes a MAOI, please consult a healthcare professional for guidance.

Warnings and Precautions

You should not use this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of drug used for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, you must wait at least two weeks after stopping an MAOI before starting this medication. If you are unsure whether your prescription includes an MAOI, please consult your healthcare provider.

In the event of an overdose, it is crucial to seek emergency medical help or contact a poison control center immediately. There are no specific general precautions or laboratory tests mentioned for this medication, but always stay informed and communicate with your doctor about any concerns you may have.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely action can make a significant difference.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of dextromethorphan, a common cough suppressant, has not been established. Before using this medication, you should consult your healthcare professional to discuss any potential risks to your fetus, as further studies are needed to fully understand its safety during pregnancy.

You should only consider using dextromethorphan if it is clearly necessary and if the potential benefits outweigh any risks to your baby. There are no specific dosage adjustments recommended for pregnant individuals, so it's crucial to seek guidance from your doctor to ensure the best care for you and your child.

Lactation Use

If you are breastfeeding, it's important to talk to your healthcare provider before using this product. There is a possibility that it could be passed into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Because of this uncertainty, it's best to exercise caution. Always prioritize your health and your baby's well-being by seeking professional advice.

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 teaspoon every 4 hours. If your child is under 6 years old, you should consult a doctor before administering the medication.

Always keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, seek medical help or contact a poison control center immediately. Your child's safety is the top priority, so make sure to follow these recommendations closely.

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 considering this medication, it’s important to consult with a healthcare provider. 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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.

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 about combining medications. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric conditions, or Parkinson's disease, you should not use this product. Additionally, you should wait at least two weeks after stopping an MAOI before starting this medication. If you're unsure whether your prescription includes an MAOI, please consult your healthcare provider for guidance.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potentially harmful interactions. Your health professional can help you understand the risks and make informed decisions about your treatment.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C and 25°C (68°F to 77°F). It’s okay for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the recommended limits. Make sure to protect the product from light to maintain its effectiveness.

For safety, always keep the product out of reach of children, and remember to discard it after opening to prevent any contamination or loss of quality. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. It's important to keep it out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help or contact a poison control center immediately.

FAQ

What is Father Johns Original used for?

Father Johns Original temporarily relieves cough due to minor throat and bronchial irritation, which may occur with a cold or inhaled irritants.

How should I take Father Johns Original?

Shake well before using. Adults and children 12 years and over should take 2 teaspoons every 4 hours, while children 6 to under 12 years should take 1 teaspoon every 4 hours.

What should I do if I overdose on Father Johns Original?

In case of overdose, get medical help or contact a poison control center right away.

Are there any warnings for using Father Johns Original?

Do not use if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a health professional if uncertain.

Is Father Johns Original safe to use during pregnancy?

The safety of Father Johns Original during pregnancy has not been established. Consult a healthcare professional before use if pregnant or planning to become pregnant.

Can nursing mothers use Father Johns Original?

Nursing mothers should consult a health professional before using this product, as there is potential for excretion in breast milk.

How should I store Father Johns Original?

Store at 20°C to 25°C (68°F to 77°F) and protect from light. Keep out of reach of children and discard after opening.

Packaging Info

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

Packaging configurations for Father Johns Medicine.
Details

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)

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 short-term use and should not be used as a substitute for addressing underlying conditions that may require medical attention.

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 of six doses within a 24-hour period.

For children aged 6 years to under 12 years, the dosage is 1 teaspoon every 4 hours, also adhering to the maximum limit 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

Use is contraindicated in the following situations:

  • The product should be kept out of reach of children to prevent accidental ingestion.

  • In the event of an overdose, immediate medical assistance or contact with a poison control center is required.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it is advised to refrain from using this product for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should be consulted if there is any uncertainty regarding the presence of an MAOI in a patient's prescription.

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a poison control center immediately. Prompt action is essential to ensure patient safety and appropriate management of the situation.

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 who are uncertain whether their prescription includes a MAOI are advised to consult a healthcare professional prior to using this product.

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

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, psychiatric or emotional conditions, and Parkinson's disease. Patients should not initiate treatment with this product if they are currently taking an MAOI or have discontinued an MAOI within the past two weeks.

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 before using this product.

Packaging & NDC

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

Packaging configurations for Father Johns Medicine.
Details

Pediatric Use

Pediatric patients aged 6 years to under 12 years may be administered 1 teaspoon every 4 hours. For children under 6 years of age, it is advised to consult a doctor before use.

It is crucial to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a poison control center should be contacted without delay.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The safety of dextromethorphan during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use. There may be potential risks to the fetus, and further studies are needed to determine the safety profile of dextromethorphan in this population.

No specific dosage modifications are provided for pregnant individuals. It is recommended that dextromethorphan be used during pregnancy only if clearly needed, and the potential benefits must justify any potential risks to the fetus.

Lactation

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

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 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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as per established protocols. Consultation with a poison control center or a medical toxicologist may be beneficial for guidance on management strategies tailored to the specific situation.

Documentation of the incident, including the substance involved, the amount ingested, and the 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

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of 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 packaging that includes specific NDC numbers. 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 maintain its integrity. Additionally, the product must be kept out of reach of children, and any unused portion 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 reach of children. In the event of an overdose, patients should seek medical assistance or contact a poison control center immediately. No further 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)

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 Father Johns Medicine, 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.