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Robitussin Maximum Strength Cough Plus Chest Congestion Dm

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Active ingredients
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 10 mg
Other brand names
Drug classes
Expectorant, 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 2013
Label revision date
January 8, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 10 mg
Other brand names
Drug classes
Expectorant, 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 2013
Label revision date
January 8, 2026
Manufacturer
Haleon US Holdings LLC
Registration number
M012
NDC root
0031-8719
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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® Cough+Chest Congestion DM is a maximum strength medication designed for adults aged 12 and over. It comes in the form of liquid-filled capsules and is formulated to provide non-drowsy relief from cough and chest congestion.

This product contains two active ingredients: dextromethorphan HBr, which acts as a cough suppressant to help reduce your urge to cough, and guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions, making it easier to drain your bronchial tubes. Together, these ingredients work to temporarily relieve cough caused by minor throat and bronchial irritation, often associated with colds, while also helping to clear mucus from your airways.

Uses

If you're dealing with a cough caused by minor irritation in your throat or bronchial tubes, especially during a cold, this medication can provide temporary relief. It works by soothing your throat and helping to ease the discomfort associated with coughing.

Additionally, this medication helps to loosen phlegm (mucus) and thin out bronchial secretions, making it easier for your body to clear out mucus from your airways. This can be particularly helpful when you're feeling congested and need to drain your bronchial tubes.

Dosage and Administration

It's important to follow the recommended dosage when taking this medication. For adults and children aged 12 years and older, you should take 2 capsules every 4 hours as needed. However, make sure not to exceed 12 capsules in a 24-hour period to avoid potential side effects.

Please note that this product is not intended for children under 12 years of age, so if you're caring for younger children, do not use this medication for them. Always adhere to these guidelines to ensure safe and effective use.

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 taking 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) 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, chronic bronchitis, or emphysema, it's important to talk to your doctor before using this product. If you are pregnant or breastfeeding, consult a healthcare professional as well. Always keep this medication out of reach of children, and in case of an 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. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

It's important to stop using this product and contact your doctor if your cough lasts more than seven days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache, as these may indicate a more serious issue. In case of an overdose, seek medical help or contact a Poison Control Center immediately. If you are pregnant or breastfeeding, please consult a healthcare professional before using this product. Lastly, keep this medication out of reach of children to ensure their safety.

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 think you or someone else may have taken too much of a medication, don’t hesitate to get help right away. Your safety is 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 product is designed for adults and is not suitable for children under 12 years of age. For older adults, there are no specific dosage adjustments or safety concerns noted, which means you can use it as directed without special precautions. However, it's always a good idea to consult with a healthcare provider to ensure that any medication is appropriate for your individual health 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 may affect you if your kidneys are not functioning properly.

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 help monitor your condition 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 may affect you if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to be cautious when taking certain medications. If you are currently using a prescription monoamine oxidase inhibitor (MAOI), or if you have stopped taking one within the last two weeks, you should avoid using this medication. Taking them together can lead to serious interactions that may affect your health.

Always discuss any medications you are taking with your healthcare provider, including any recent changes. This ensures that you receive safe and effective treatment tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to avoid exposing it to excessive heat, as temperatures above 40°C (104°F) can damage the product.

When handling the product, make sure to maintain a clean environment to prevent contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the effectiveness of the product.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is Robitussin® Cough+Chest Congestion DM used for?

Robitussin® Cough+Chest Congestion DM temporarily relieves cough due to minor throat and bronchial irritation, as may occur with a cold, and helps loosen phlegm (mucus) to drain bronchial tubes.

Who can use Robitussin® Cough+Chest Congestion DM?

This product is intended for adults and children aged 12 years and over. It should not be used by children under 12 years of age.

What are the active ingredients in Robitussin® Cough+Chest Congestion DM?

The active ingredients are Dextromethorphan HBr, which acts as a cough suppressant, and Guaifenesin, which is an expectorant that helps loosen mucus.

What is the recommended dosage for adults and children over 12?

The recommended dosage is 2 capsules every 4 hours, with a maximum of 12 capsules in any 24-hour period.

Are there any contraindications for using this product?

Do not use Robitussin® Cough+Chest Congestion DM if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last 2 weeks.

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

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

Is it safe to use Robitussin® Cough+Chest Congestion DM if I am pregnant or breastfeeding?

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

How should I store Robitussin® Cough+Chest Congestion DM?

Store the product at 20-25°C (68-77°F) and avoid excessive heat above 40°C (104°F).

What should I do in case of an overdose?

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

Packaging Info

Below are the non-prescription pack sizes of Robitussin Maximum Strength Cough Plus Chest Congestion Dm (dextromethorphan hydrobromide and guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Robitussin Maximum Strength Cough Plus Chest Congestion Dm.
Details

Drug Information (PDF)

This file contains official product information for Robitussin Maximum Strength Cough Plus Chest Congestion Dm, 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. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 capsules every 4 hours as needed. It is imperative that the total dosage does not exceed 12 capsules within a 24-hour period. 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

Use of this product is contraindicated in individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it is advised to refrain from using this product for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should be consulted if there is uncertainty regarding the presence of an MAOI in a prescribed medication.

Patients should be 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. These symptoms may indicate a more serious underlying condition that requires further evaluation.

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

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to using this product to ensure safety for both the mother and child.

This product should be stored out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals taking prescription monoamine oxidase inhibitors (MAOIs) for depression, psychiatric, or emotional conditions, or Parkinson's disease. The use of this product is contraindicated in patients currently taking an MAOI or within 2 weeks of discontinuing such medication.

Patients are advised to stop use and consult a doctor if their cough persists for more than 7 days, returns, 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 seek medical advice if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Additional considerations include the need for pregnant or breastfeeding individuals to consult a healthcare professional prior to use. It is also important to keep this product out of reach of children. In the event of an overdose, patients should 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. Patients should not take this medication while on an MAOI 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 necessary beyond the contraindication noted above.

Packaging & NDC

Below are the non-prescription pack sizes of Robitussin Maximum Strength Cough Plus Chest Congestion Dm (dextromethorphan hydrobromide and guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Robitussin Maximum Strength Cough Plus Chest Congestion Dm.
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, defined as those aged 65 years and older, may use this adult product; however, it is important to note that the product is not intended for use in children under 12 years of age.

The prescribing information does not specify any dosage adjustments or safety concerns specifically for geriatric patients. Additionally, there are no special precautions indicated for elderly patients in the provided text.

Healthcare providers should continue to monitor elderly patients for any potential adverse effects, as individual responses to treatment may vary.

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 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 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 scenario.

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

No postmarketing experience details are available in the insert text.

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. Healthcare providers should encourage patients to consult with a doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Patients should be advised 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, healthcare providers should recommend that patients seek medical advice before using the medication if they have a cough associated with excessive phlegm (mucus) or if they have a chronic cough due to smoking, asthma, chronic bronchitis, 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 temperature range of 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain product integrity. Proper storage conditions are crucial for ensuring the efficacy and safety of the product.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Robitussin Maximum Strength Cough Plus Chest Congestion Dm, 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 Maximum Strength Cough Plus Chest Congestion Dm, 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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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.