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Robitussin Direct Cough

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Active ingredient
Dextromethorphan Hydrobromide 15 mg
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
March 18, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dextromethorphan Hydrobromide 15 mg
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Capsule, Liquid Filled
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 2022
Label revision date
March 18, 2024
Manufacturer
Haleon US Holdings LLC
Registration number
M012
NDC root
0031-9302
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

Robitussin is a cough suppressant that contains dextromethorphan HBr, which helps to temporarily relieve coughing caused by minor irritation in the throat and bronchial area, often associated with a cold. This medication works by acting on the brain to reduce the urge to cough, providing you with some relief during uncomfortable coughing spells.

Robitussin is available in the form of Liqui-Gels, which are liquid-filled capsules designed for easy swallowing. If you're dealing with a persistent cough, this product may help soothe your symptoms and make you feel more comfortable.

Uses

You can use this medication to temporarily relieve a cough caused by minor irritation in your throat and bronchial tubes, which often happens when you have a cold. It helps soothe your symptoms, making it easier for you to feel comfortable.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

You should take this medication carefully to ensure your safety and effectiveness. If you are an adult or a child aged 12 years and older, you can take 1 capsule (15 mg) every 4 hours as needed. However, make sure not to exceed 8 capsules in a 24-hour period.

It's important to note that this product is not suitable for children under 12 years of age, so please do not use it for younger children. Always follow these guidelines to help manage your symptoms safely.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric, or emotional conditions, or Parkinson's disease. Additionally, do not use this product for at least two weeks after stopping an MAOI. If you're unsure whether your prescription includes an MAOI, it's important to consult with your doctor or pharmacist before using this product.

Taking this medication while on an MAOI can lead to serious health risks, so please prioritize your safety by following these guidelines closely.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is used for certain mental health conditions, or if you have stopped taking one within the last two weeks, do not use this product. If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, stop using the medication and consult a doctor, as these may indicate a more serious health issue.

Before using this medication, it's advisable to consult a doctor if you have a cough with excessive mucus or if you have a chronic cough due to smoking, asthma, or emphysema. In case of an overdose, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist before using this product.

Before using this product, it's important to talk to your doctor if you have a cough that produces a lot of mucus, or if you have a chronic cough due to smoking, asthma, or emphysema. If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, stop using the product and contact your doctor, as these may be signs of a more serious issue.

In the event of an overdose, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than typical side effects.

Always err on the side of caution—if you or someone else is experiencing concerning symptoms after taking medication, don’t hesitate to reach out for professional assistance. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

This product is specifically designed for adults and is not suitable for children under 12 years of age. If you have a child who is younger than 12, it is important to avoid using this medication for their safety. Always consult with a healthcare professional if you have questions about appropriate treatments for your child.

Geriatric Use

This medication is designed for adults and is not suitable for children under 12 years old. If you are 12 years or older, the recommended dosage is one capsule (15 mg) every four hours as needed. It's important to note that you must be at least 18 years old to purchase this product.

As you consider using this medication, keep in mind that older adults may have different health needs. Always consult with a healthcare provider to ensure that this medication is appropriate for you, especially if you have any underlying health conditions or are taking other medications.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you or how it should be adjusted based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health needs. They can help monitor your kidney function and make any necessary adjustments to your treatment plan.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand how to manage your treatment effectively.

Drug Interactions

It's important to be cautious about the medications you take together. If you are currently using a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, psychiatric conditions, or Parkinson's disease, you should not use this drug. Additionally, you should wait at least two weeks after stopping an MAOI before starting this medication.

Always discuss your current medications and any recent changes with your healthcare provider. They can help ensure that your treatment is safe and effective, minimizing the risk of harmful interactions.

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 important to avoid exposing it to excessive heat, particularly temperatures above 40°C (104°F), as this can compromise its effectiveness. Additionally, keep the product protected from light to maintain its quality.

When handling the product, always do so with clean hands and in a clean environment to prevent contamination. Following these storage and handling guidelines will help ensure that the product remains safe and effective for your use.

Additional Information

There are a few important points to keep in mind regarding the use of this medication. First, you must be 18 years or older to purchase it. If you are a parent, it's crucial to educate yourself about the potential for medicine abuse among teenagers; you can find helpful resources at www.StopMedicineAbuse.org.

If you are pregnant or breastfeeding, consult a healthcare professional before using this medication. Always keep it out of reach of children. In the event of an overdose, seek medical assistance or contact a Poison Control Center immediately.

FAQ

What is Robitussin used for?

Robitussin is a cough suppressant that temporarily relieves cough due to minor throat and bronchial irritation, often associated with a cold.

How should I take Robitussin?

Adults and children 12 years and over should take 1 capsule (15 mg) every 4 hours as needed, but do not exceed 8 capsules in a 24-hour period.

Is Robitussin safe for children?

No, Robitussin is not intended for use in children under 12 years of age.

Are there any contraindications for using Robitussin?

Do not use Robitussin if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one in the last 2 weeks.

What should I do if my cough lasts more than 7 days?

Stop using Robitussin and consult a doctor if your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or persistent headache.

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately.

Can I use Robitussin if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using Robitussin.

How should I store Robitussin?

Store Robitussin at 20°C-25°C (68°F-77°F) and protect it from excessive heat and light.

Packaging Info

Below are the non-prescription pack sizes of Robitussin Direct Cough (dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Robitussin Direct Cough.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Robitussin is a cough formulation that contains Dextromethorphan HBr, a cough suppressant. The product is presented in the form of liquid-filled capsules, with a total of 18 Liqui-Gels per package.

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.

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

Dosage and Administration

Adults and children aged 12 years and over are advised to take 1 capsule (15 mg) every 4 hours as needed. It is important to note that no more than 8 capsules should be taken within a 24-hour period. This product is not intended for use in children under 12 years of age; therefore, it should not be administered to this population.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if they are uncertain whether their prescription medication contains an MAOI.

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 product should not be used for at least two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Healthcare professionals should advise patients to seek medical guidance before using this product if they have a cough that is associated with excessive phlegm (mucus) or if they have a chronic cough, which may be indicative of underlying conditions such as smoking, asthma, or emphysema.

Patients are instructed to discontinue use and contact their healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a more serious medical condition that requires further evaluation.

In the event of an overdose, it is critical to seek immediate medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious warnings include the contraindication of use in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. Patients uncertain about whether their prescription contains an MAOI are advised to consult a healthcare professional prior to use.

Patients are instructed to discontinue use and seek medical advice if a cough persists for more than seven days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Before using this product, patients should consult a healthcare provider if they have a cough associated with excessive phlegm (mucus) or if they experience a chronic cough related to smoking, asthma, or emphysema.

In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, certain psychiatric conditions, or Parkinson's disease. Patients should not initiate therapy with this medication while currently on an MAOI or within 14 days following the discontinuation of an MAOI. This precaution is essential to avoid potentially serious interactions that may arise from the pharmacodynamic effects of both drug classes.

Packaging & NDC

Below are the non-prescription pack sizes of Robitussin Direct Cough (dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Robitussin Direct Cough.
Details

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. There are no established safety or efficacy profiles for children in this age group, and therefore, it is contraindicated for use in this population.

Geriatric Use

Elderly patients should be aware that this product is not intended for use in children under 12 years of age. For adults, including geriatric patients aged 65 and older, the recommended dosage is 1 capsule (15 mg) every 4 hours, as required.

It is important to note that patients must be 18 years or older to purchase this product. Healthcare providers should exercise caution when prescribing this medication to elderly patients, considering potential age-related physiological changes that may affect drug metabolism and clearance. Monitoring for efficacy and adverse effects is recommended, as older adults may be more susceptible to side effects. Adjustments to the dosage may be necessary based on individual patient response and tolerance.

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 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 have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to ensure appropriate interventions are implemented in a timely manner.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of 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 must be informed not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. It is important for patients to consult with their doctor or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Healthcare providers should also counsel patients to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious condition.

Additionally, patients should be encouraged to seek medical advice before using this medication if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, or emphysema.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20°C to 25°C (68°F to 77°F). Care must be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Additionally, the product must be protected from light to maintain its integrity and efficacy.

Additional Clinical Information

Patients should be aware that the product is intended for individuals aged 18 or older, and parents are encouraged to educate themselves about the potential for medicine abuse among teenagers by visiting www.StopMedicineAbuse.org.

Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is crucial to keep the product out of reach of children, and in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is recommended.

Drug Information (PDF)

This file contains official product information for Robitussin Direct Cough, 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 Robitussin Direct Cough, 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.