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Robitussin Elderberry Maximum Strength Cough Plus Chest Congestion Dm

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Active ingredients
  • Guaifenesin 400 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
November 25, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 400 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Solution
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 2021
Label revision date
November 25, 2025
Manufacturer
Haleon US Holdings LLC
Registration number
M012
NDC root
0031-2097
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Robitussin Elderberry Cough+Chest Congestion DM is a maximum strength medication designed for individuals aged 12 and older. It contains two active ingredients: dextromethorphan HBr, which acts as a cough suppressant to temporarily relieve cough caused by minor throat and bronchial irritation, and guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions, making it easier to drain the bronchial tubes.

This product is particularly useful for alleviating symptoms associated with colds, as it controls cough and relieves chest congestion by thinning and loosening mucus. With its elderberry flavor, it aims to provide a soothing experience while addressing your cough and congestion needs.

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. Additionally, it helps to loosen phlegm (a thick mucus) and thin out bronchial secretions, making it easier for your body to drain the bronchial tubes. This can provide you with some comfort and ease your breathing during a cold.

Dosage and Administration

When using this medication, it's important to follow the dosing instructions carefully. For adults and children aged 12 years and older, you should take 20 milliliters (mL) every 4 hours. However, make sure not to exceed 6 doses within a 24-hour period. To ensure accurate dosing, always use the dosing cup that comes with the product, and keep it handy for each use.

Please note that this medication is not intended for children under 12 years of age, so do not use it for younger individuals. Following these guidelines will help you use the medication safely and effectively.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which are medications often prescribed for depression, psychiatric 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 precaution is crucial to prevent serious interactions and ensure your safety. Always prioritize your health by seeking professional advice when in doubt.

Side Effects

You should be aware of some important warnings regarding this medication. Do not use it 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.

If your cough lasts more than seven days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache, stop using the medication and seek medical advice, as these could indicate a more serious issue. Additionally, consult your doctor before using this product if you have a cough with excessive mucus or if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema. Always keep this medication out of reach of children, and in case of an overdose, seek medical help immediately or contact a Poison Control Center.

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 your cough is chronic, such as from smoking, asthma, chronic bronchitis, 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 condition.

In the event of an overdose, seek medical help immediately or contact a Poison Control Center. 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 drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always keep emergency contact numbers handy and be aware of the signs of overdose to ensure you can respond effectively if needed.

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 should not be used in children under 12 years of age. If you have a child who is younger than 12, it’s important to avoid giving them this medication. 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 old. If you are an older adult, the recommended dosage is 20 mL every 4 hours, but it's important to consult with your doctor before using it, especially if you have a cough that produces a lot of mucus, or if you have a history of smoking, asthma, chronic bronchitis, or emphysema.

If your cough lasts more than 7 days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache, you should stop using the product and seek medical advice. These symptoms could indicate a more serious health issue that needs attention. Always prioritize your health and safety by discussing any concerns with your healthcare provider.

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 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 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 crucial to talk to your healthcare provider about any medications you are currently taking, especially if you are on a prescription monoamine oxidase inhibitor (MAOI). Using this medication while taking an MAOI or within two weeks of stopping it can lead to serious interactions that may affect your health.

Always keep your healthcare team informed about your medications to ensure your safety and the effectiveness of your treatment. They can help you navigate any potential risks and make informed decisions about your care.

Storage and Handling

To ensure the best performance of your product, store it at room temperature between 20-25°C (68-77°F). It's important not to refrigerate the product, as this could affect its effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any additional safety instructions provided to ensure safe and effective use.

Additional Information

You can take this medication orally. 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. Currently, there are no additional details available regarding laboratory tests, patient counseling, or postmarketing experiences related to this medication.

FAQ

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

Robitussin Elderberry 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.

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

It contains DEXTROMETHORPHAN HBr, a cough suppressant, and GUAIFENESIN, an expectorant.

Who can use this product?

This product is intended for adults and children aged 12 years and older.

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

The recommended dosage is 20 mL every 4 hours, with a maximum of 6 doses in any 24-hour period.

Are there any contraindications for using this product?

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

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

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.

What should I do in case of overdose?

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

Can I use this product if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

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

Store the product at 20-25°C (68-77°F) and do not refrigerate.

Packaging Info

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

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

Drug Information (PDF)

This file contains official product information for Robitussin Elderberry 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 over are advised to take 20 mL every 4 hours as needed. It is imperative that no more than 6 doses are administered within a 24-hour period. The dosing cup provided with the product must be used for accurate measurement, and it should be kept with the product at all times.

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 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 medication 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, chronic bronchitis, 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 crucial to seek immediate medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this product. It is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this product should not be used for at least two weeks after discontinuing an MAOI. Patients uncertain about whether their prescription includes an MAOI are advised to consult a healthcare professional before use.

Patients are instructed to stop using the product and seek medical advice if their cough persists for more than seven 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 (mucus) or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

It is essential to keep this product out of the 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 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 further dosage adjustments or monitoring recommendations are necessary beyond the contraindication with MAOIs.

Packaging & NDC

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

Packaging configurations for Robitussin Elderberry 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. 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 may require special consideration when using this product, which 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 20 mL every 4 hours.

It is important for healthcare providers to advise geriatric patients to consult a physician prior to use if they experience a cough that is productive with excessive phlegm, or if the cough is chronic, as seen in conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Additionally, healthcare providers should instruct elderly patients to discontinue use and seek medical advice if the cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition. Careful monitoring and appropriate dose adjustments may be necessary to ensure the safety and efficacy of treatment in this population.

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 maternal health. 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 regarding 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 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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: nausea, vomiting, dizziness, and allergic reactions, which include rash, itching, and swelling.

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 temperature range of 20-25°C (68-77°F). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper storage conditions must be maintained to ensure optimal efficacy and safety.

Additional Clinical Information

Patients should be informed that the medication is administered orally. Clinicians are encouraged to educate patients about the potential for medicine abuse, particularly among teens, and can refer to resources such as www.StopMedicineAbuse.org for further information. There are no additional details available regarding laboratory tests, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Robitussin Elderberry 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 Elderberry 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.