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Robitussin Long-Acting Cough Soft Chews

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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
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
November 25, 2025
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
Tablet, Chewable
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 2024
Label revision date
November 25, 2025
Manufacturer
Haleon US Holdings LLC
Registration number
M012
NDC root
0031-9310
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

Robitussin Long-Acting Cough Soft Chews are chewable tablets that contain dextromethorphan HBr (a cough suppressant) to help temporarily relieve coughs caused by minor throat and bronchial irritation, which can occur with a cold. These soft chews come in a pleasant berry flavor and provide up to 8 hours of cough relief, making them a convenient option for fast relief wherever you are.

Each package contains 10 chewable tablets, designed to be chewed completely before swallowing for effective results.

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 throat and makes it easier for you to feel comfortable while you recover.

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

When using this medication, it's important to follow the dosage instructions carefully. If you are an adult or a child aged 12 years and older, you can take 2 chewable tablets every 6 to 8 hours as needed. However, make sure not to exceed 4 doses (which is 8 chewable tablets) in a 24-hour period unless your doctor advises otherwise.

Before swallowing, be sure to chew the tablets completely. Please note that this product is not suitable for children under 12 years of age, so do not give it to younger children. Always consult with your healthcare provider if you have any questions or concerns about using this medication.

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, please consult your doctor or pharmacist before using this product.

It's important to follow these guidelines to prevent potential serious interactions and ensure your safety. Always prioritize open communication with your healthcare provider regarding any medications you are taking.

Side Effects

You should be aware of some important information regarding potential side effects and warnings associated with this medication. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson's disease, do not use this product, and wait at least two weeks after stopping the MAOI before starting it.

If your cough lasts more than seven 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 condition. Additionally, if you have a cough with excessive mucus or a chronic cough due to smoking, asthma, or emphysema, it's advisable to speak with a healthcare professional before use. Pregnant or breastfeeding individuals should also consult a health professional prior to use. Always keep this medication out of reach of children, and in case of overdose, seek medical help 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 medication, 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 seven 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. Your health and safety are important, so please take these precautions seriously.

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 notice anything concerning, don’t hesitate to reach out for 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 them. 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 an older adult or caring for one, it's important to follow the recommended dosage carefully. For those aged 12 and older, the typical dose is 2 chewable tablets every 6 to 8 hours, as needed.

Always consult with a healthcare provider before starting any new medication, especially if there are concerns about age-related health issues or other medications being taken. This ensures that the treatment is safe and effective for your specific needs.

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 should be used if you have 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 health situation. 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).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's crucial to talk to your healthcare provider about any medications you are currently taking. If you are on a prescription monoamine oxidase inhibitor (MAOI), you should not use this medication while taking the MAOI or for at least two weeks after stopping it, as this can lead to serious interactions that may affect your health.

Since there are no other specific drug interactions or laboratory test interactions noted, it's still important to keep your healthcare provider informed about all the medications and supplements you are using. This helps ensure your treatment is safe and effective.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20-25°C (68-77°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dosage is 2 chewable tablets every 6 to 8 hours as needed.

It's important to be aware of the potential for medicine abuse, especially among teens. For more information on this topic, you can visit www.StopMedicineabuse.org.

FAQ

What is Robitussin Long-Acting Cough Soft Chews used for?

Robitussin Long-Acting Cough Soft Chews temporarily relieve cough due to minor throat and bronchial irritation, often caused by a cold.

How many chewable tablets are in a package?

Each package contains 10 chewable tablets.

How should I take Robitussin Long-Acting Cough Soft Chews?

You should chew the tablets completely before swallowing. Adults and children 12 years and over can take 2 tablets every 6 to 8 hours as needed.

Are there any age restrictions for using this product?

This product is not intended for use in children under 12 years of age.

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

You should stop use and ask a doctor if your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

Can I take Robitussin if I am on a monoamine oxidase inhibitor (MAOI)?

No, do not use this product if you are currently taking a prescription MAOI or for 2 weeks after stopping an MAOI, as it can lead to serious interactions.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

Is it safe to use Robitussin if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this product.

What is the recommended storage condition for Robitussin Long-Acting Cough Soft Chews?

Store the product at a controlled room temperature of 20-25°C (68-77°F).

Packaging Info

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

Packaging configurations for Robitussin Long-Acting Cough Soft Chews.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

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 12 years and older are advised to take 2 chewable tablets every 6 to 8 hours as needed. It is important to chew the tablets completely before swallowing. The maximum dosage should not exceed 4 doses, or 8 chewable tablets, within a 24-hour period unless otherwise directed by a healthcare professional. This product is not intended for use in children under 12 years of age.

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

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 should not be used for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their prescription medications.

Healthcare providers should exercise caution and recommend that patients seek medical advice prior to use if they experience a cough accompanied by excessive phlegm (mucus) or if the cough is chronic, as seen in conditions such as smoking, asthma, or emphysema.

Patients are advised to discontinue use and consult a healthcare professional 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 underlying condition that requires further evaluation.

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

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this product.

Serious adverse reactions may occur, particularly in patients who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this product is contraindicated in such cases, and patients are advised to consult a healthcare professional if they are uncertain whether their prescription includes an MAOI.

Patients are also advised to stop use and seek medical attention if their cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Before using this product, patients should consult a healthcare provider if they have a cough that produces excessive phlegm or if they have a chronic cough associated with smoking, asthma, or emphysema.

Additional considerations include the need for pregnant or breastfeeding patients to seek advice from a healthcare professional prior to use. It is also crucial to keep this product out of reach of children, and in the event of an overdose, patients should obtain medical assistance or contact a Poison Control Center immediately.

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 MAOI therapy, as this may result in serious interactions.

No additional drug interactions or laboratory test interactions have been identified for this medication. Therefore, no specific dosage adjustments or monitoring recommendations are necessary beyond the contraindication with MAOIs.

Packaging & NDC

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

Packaging configurations for Robitussin Long-Acting Cough Soft Chews.
Details

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. Children under this age should not use this medication.

Geriatric Use

Elderly patients may utilize this product; however, it is not intended for use in children under 12 years of age. For adults and children aged 12 years and older, the recommended dosage is 2 chewable tablets every 6 to 8 hours, as needed.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, as age-related physiological changes may affect drug metabolism and clearance. It is advisable to monitor elderly patients closely for any adverse effects or changes in efficacy, and to consider potential dose adjustments based on individual patient response and tolerability.

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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 not been specifically addressed in the drug insert text 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 data 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 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 for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert and prepared to implement appropriate management strategies in response to an overdose situation, ensuring the safety and well-being of the patient.

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 the following adverse reactions reported voluntarily or through surveillance programs: nausea, vomiting, dizziness, and drowsiness. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients to keep the 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 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 the medication if they have a cough that produces excessive phlegm 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 is essential to store the product at a controlled room temperature, maintaining a range of 20-25°C (68-77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 chewable tablets orally every 6 to 8 hours as needed. Clinicians should be aware of the potential for medicine abuse among teens and can refer to resources such as www.StopMedicineabuse.org for further information. No additional data are available regarding laboratory tests, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Robitussin Long-Acting Cough Soft Chews, 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 Long-Acting Cough Soft Chews, 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.

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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.