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Dextromethorphan hydrobromide/Guaifenesin

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Active ingredients
  • Guaifenesin 10 mg/5 mL – 1200 mg
  • Dextromethorphan Hydrobromide 20 mg/100 mL – 60 mg
Reference brand
Coricidin Hbp Chest Congestion and Cough
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage forms
  • Capsule
  • Capsule, Gelatin Coated
  • Capsule, Liquid Filled
  • Granule
  • Liquid
  • Solution
  • Suspension
  • Syrup
  • Tablet
  • Tablet, Coated
  • Tablet, Effervescent
  • Tablet, Extended Release
  • Tablet, Film Coated
Routes
  • Oral
  • Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2000
Label revision date
March 23, 2026
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Active ingredients
  • Guaifenesin 10 mg/5 mL – 1200 mg
  • Dextromethorphan Hydrobromide 20 mg/100 mL – 60 mg
Reference brand
Coricidin Hbp Chest Congestion and Cough
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage forms
  • Capsule
  • Capsule, Gelatin Coated
  • Capsule, Liquid Filled
  • Granule
  • Liquid
  • Solution
  • Suspension
  • Syrup
  • Tablet
  • Tablet, Coated
  • Tablet, Effervescent
  • Tablet, Extended Release
  • Tablet, Film Coated
Routes
  • Oral
  • Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2000
Label revision date
March 23, 2026
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Product Labels (475)
Product Labels (475)

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If you are a consumer or patient please visit this version.

Drug Overview

Mucus Relief DM is a medication designed to help alleviate cough and chest congestion caused by minor throat and bronchial irritation, often associated with the common cold. It contains two active ingredients: Dextromethorphan HBr, which acts as a cough suppressant, and Guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions. This combination works to make coughs more productive by clearing mucus from the airways.

By temporarily relieving cough and helping to drain bronchial tubes, Mucus Relief DM can provide comfort during cold symptoms. It is available in various forms, including extended-release tablets and liquid solutions, and is intended for use by adults and children aged 12 and older.

Uses

You can use this medication to temporarily relieve cough caused by minor throat and bronchial irritation, which often occurs with a cold. It helps loosen phlegm (mucus) and thin bronchial secretions, making it easier to drain the bronchial tubes and clear your airways.

Additionally, this medication can help reduce the intensity of coughing and the urge to cough, which may assist you in getting a better night's sleep. Overall, it aims to make your coughs more productive by clearing out bothersome mucus from your respiratory system.

Dosage and Administration

You should follow these dosage instructions carefully to ensure safe and effective use of the medication.

For adults and children aged 12 years and older, take 20 mL (or 2 teaspoonfuls) every 4 hours, not exceeding 6 doses in a 24-hour period. If you are using extended-release tablets, take 1 tablet every 12 hours, with a maximum of 2 tablets in 24 hours. Always take the tablets with a full glass of water and do not crush, chew, or break them.

For children aged 6 to under 12 years, the dosage is 5 mL to 10 mL every 4 hours, also not exceeding 6 doses in a 24-hour period. For children aged 4 to under 6 years, the recommended dose is 2.5 mL to 5 mL every 4 hours. Children under 4 years should not use this medication. Always measure the dose using the provided dosing cup and shake the liquid well before use.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) (a type of medication for depression, psychiatric, or emotional conditions, or Parkinson's disease) or if you have stopped taking an MAOI within the last two weeks. If you are unsure whether your prescription contains an MAOI, please consult a doctor or pharmacist before using this product. Additionally, do not use this product for children under 12 years of age, and do not exceed the recommended dosage. If your cough lasts more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache, seek medical advice, as these may indicate a serious condition.

Side Effects

You should be aware of several important warnings and potential side effects when using cough and mucus relief medications. Do not use these products if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which are medications for depression or certain psychiatric conditions, or if you have stopped taking an MAOI within the last two weeks. If you are unsure whether your medication contains an MAOI, consult your doctor or pharmacist.

It's crucial to stop using the medication and consult a doctor if your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or persistent headache, as these could indicate a serious condition. Additionally, if you have a persistent or chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive phlegm (mucus), you should seek medical advice before using these products. Always keep these medications out of reach of children and seek immediate medical help in case of overdose.

Warnings and Precautions

  • Do not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which are medications for depression, psychiatric conditions, or Parkinson's disease, or for 2 weeks after stopping an MAOI. If you're unsure whether your medication contains an MAOI, consult your doctor or pharmacist.

  • This product is not recommended for children under 12 years of age. If you are giving this product to a child, do not use it if they are taking an MAOI or have taken one in the last 2 weeks.

  • Before using, ask your doctor if you have a persistent or chronic cough (lasting more than 7 days) or a cough that produces excessive phlegm (mucus). These symptoms may indicate a serious condition.

  • Stop using this product and consult your doctor if your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious illness.

  • In case of overdose, seek immediate medical help or contact a Poison Control Center at 1-800-222-1222.

Overdose

In the event of an overdose of cough and congestion medications, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Signs of overdose may not always be apparent, so prompt action is essential even if you do not notice any symptoms.

Most products do not provide specific information about overdose effects, but it is generally advised to avoid exceeding the recommended dosage. If you suspect an overdose, do not hesitate to reach out for professional assistance. Always keep these medications out of reach of children to prevent accidental ingestion.

Pregnancy Use

If you are pregnant or planning to become pregnant, it is important to consult a healthcare professional before using any medications, including those for cough and congestion. The safety of many products has not been established during pregnancy, and there may be potential risks to the fetus. Specific studies or data regarding these risks are often lacking, so caution is advised.

In general, if you are pregnant or breastfeeding, always ask a health professional before using any medication. This includes over-the-counter products like cough syrups and expectorants. No specific dosage modifications are typically provided for pregnant individuals, so personalized guidance from your healthcare provider is essential.

Lactation Use

If you are breastfeeding, it's important to consult a healthcare professional before using any medication, especially if you are pregnant or nursing. While some products, like Rompe Pechito and certain children's cough syrups, do not have specific warnings for nursing mothers, they also lack information on whether their ingredients can pass into breast milk or affect your infant.

In general, many medications recommend that you seek advice from a health professional before use during breastfeeding. This is to ensure the safety of both you and your baby, as the effects of many substances on nursing infants are not well studied. Always prioritize your health and your baby's well-being by discussing any concerns with your doctor.

Pediatric Use

You should be cautious when using cough and congestion medications for children. Here are some important guidelines:

  • Age Restrictions: Most products are not recommended for children under 12 years of age. For those aged 6 to under 12, specific dosages vary:

    • 6 to under 12 years: Common dosages range from 5 mL to 15 mL every 4 hours, depending on the product.

    • 4 to under 6 years: Dosages typically range from 2.5 mL to 5 mL every 4 hours, but some products require a doctor's consultation.

    • Under 4 years: Generally, do not use unless directed by a doctor.

  • Precautions: Do not give these medications if your child is taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks after stopping it. Always consult a doctor if your child has a persistent cough, cough with excessive mucus, or if symptoms last more than 7 days, are accompanied by fever, rash, or persistent headache.

  • Overdose Warning: Keep all medications out of reach of children. In case of overdose, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

When considering cough and chest congestion medications, it's important to note that many products do not provide specific guidelines for older adults. Generally, these medications are intended for adults and children aged 12 years and older, with a common dosage of 20 mL every 4 hours for liquid forms. However, caution is advised for elderly patients due to potential increased sensitivity to side effects and the likelihood of reduced kidney function, which may require dosage adjustments.

While no specific dosage adjustments or safety concerns are mentioned for elderly patients in most product inserts, it is always best to consult with a healthcare professional before starting any new medication. This is especially important if you have chronic conditions or are taking other medications, as interactions may occur. If you experience a cough that lasts more than 7 days, or if it is accompanied by fever, rash, or persistent headache, seek medical advice promptly.

Renal Impairment

If you have kidney problems, it's important to be aware that certain medications may require dosage adjustments. For example, medications like Good Neighbor Sugar Free Adult Tussin DM, Equaline Mucus DM, and Maximum Strength Adult Cough Plus Chest Congestion DM recommend monitoring your renal function regularly and adjusting doses based on your creatinine clearance levels. This is particularly crucial for those with moderate to severe renal impairment, as a reduced dose may be necessary to avoid potential toxicity.

Before starting any new medication, especially if you have renal impairment, it's advisable to have your renal function tested. Regular monitoring can help ensure your safety and the effectiveness of the treatment. Always consult with your healthcare provider for personalized advice and recommendations tailored to your specific health needs.

Hepatic Impairment

If you have liver problems, it's important to be aware that certain medications may require special attention. For some products, such as Good Neighbor Sugar Free Adult Tussin DM, Maximum Strength Adult Cough Plus Chest Congestion DM, and Equaline Mucus DM, your liver's ability to process the medication may be affected. This could mean that dosage adjustments might be necessary, and monitoring of liver function tests is recommended to ensure your safety.

Always consult with your healthcare provider before taking any medication if you have hepatic impairment (a condition where the liver does not function properly). They may suggest a reduced dose or alternative therapies to avoid potential complications.

Drug Interactions

If you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks, you should not use any products containing dextromethorphan. This includes many cough and chest congestion medications, as using them together can lead to serious interactions. It's crucial to discuss your medications with a healthcare provider to ensure your safety, especially if you're unsure whether your prescription includes an MAOI. Always consult a doctor or pharmacist if you have questions about your medications or their potential interactions.

Storage and Handling

To ensure the effectiveness and safety of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). Some products can be stored between 15°C to 30°C (59°F to 86°F), but avoid refrigeration as it may affect the product's quality. Always keep the container tightly closed and protect it from excessive heat and humidity.

Before use, check for any tampering; do not use the product if the seal is broken or missing. After opening, discard any unused product as directed, and keep it out of reach of children. If you have any questions about specific products, refer to the packaging for detailed instructions.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation as may occur with a cold. It helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes, making coughs more productive. Additionally, it may control cough and relieve chest congestion.

Specific Indications

  • Cough Relief: Temporarily relieves cough associated with minor throat and bronchial irritation due to the common cold or inhaled irritants.

  • Mucus Management: Aids in loosening phlegm and thinning bronchial secretions to facilitate the drainage of mucus from the bronchial passageways.

  • Cough Control: Reduces the intensity of coughing and the impulse to cough, which may help individuals sleep better.

Limitations of Use

  • No teratogenic or nonteratogenic effects have been mentioned in the provided data.

Dosage and Administration

Adults and children 12 years and older are recommended to take 20 mL every 4 hours, not exceeding 6 doses in a 24-hour period. For children aged 6 to under 12 years, the dosage is 5 mL to 10 mL every 4 hours, while children aged 4 to under 6 years should receive 2.5 mL to 5 mL every 4 hours. Children under 4 years of age should not use this product.

All liquid formulations should be shaken well before use, and the dosing cup provided must be used for accurate measurement. It is important to keep the dosing cup with the product and not to use it with other medications.

For extended-release tablets, adults and children 12 years and older should take 1 or 2 tablets every 12 hours, with a maximum of 4 tablets in 24 hours. These tablets should not be crushed, chewed, or broken and should be taken with a full glass of water. The product can be administered without regard for timing of meals. Children under 12 years of age should not use this product.

In all cases, if symptoms persist or worsen, a healthcare professional should be consulted.

Contraindications

Do not use in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If there is uncertainty regarding whether a prescription drug contains an MAOI, consultation with a doctor or pharmacist is advised.

Additionally, do not use in children under 12 years of age.

This product is contraindicated for persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, or if the cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.

Warnings and Precautions

Do not use if currently taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If unsure whether a prescription drug contains an MAOI, consult a doctor or pharmacist before use.

Warnings:

  • Do not use for children under 12 years of age.

  • A persistent cough may be a sign of a serious condition. If cough lasts more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

  • Do not exceed the recommended dosage.

  • Do not use if there is a known allergy to any ingredients in this product.

General Precautions:

  • Ask a doctor before use if you have:

    • A cough that occurs with excessive phlegm (mucus).

    • A persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

    • If pregnant or breastfeeding, consult a healthcare professional before use.

Stop Taking and Call Your Doctor:

  • Stop use and ask a doctor if:

    • Cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

    • Symptoms are accompanied by fever, rash, or persistent headache.

Get Emergency Medical Help:

  • In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Side Effects

Patients using products containing Guaifenesin and Dextromethorphan HBr should be aware of several important warnings and potential adverse reactions.

Serious Warnings

  • Use of these products is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson's disease, and for 2 weeks after discontinuation of the MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription, patients should consult a healthcare professional.

  • A persistent cough may indicate a serious condition. Patients should seek medical advice if their cough lasts more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

Cough-Related Warnings

  • Patients should consult a doctor before using these products if they have:

    • A cough that occurs with excessive phlegm (mucus).

    • A persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema.

Additional Considerations

  • In case of overdose, patients should seek immediate medical assistance or contact a Poison Control Center.

  • If pregnant or breastfeeding, patients should consult a healthcare professional before use.

Common Adverse Reactions

While specific adverse reactions were not detailed in the provided data, the following symptoms may occur:

  • Nervousness

  • Dizziness

  • Sleeplessness

Patients are advised to monitor for these symptoms and report any concerning reactions to their healthcare provider.

Summary

In summary, patients should be vigilant regarding the use of Guaifenesin and Dextromethorphan HBr products, particularly in relation to MAOI interactions, persistent coughs, and potential adverse reactions. Regular consultation with healthcare professionals is recommended to ensure safe and effective use of these medications.

Drug Interactions

Dextromethorphan, a common ingredient in many cough and cold medications, should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or for two weeks after discontinuing an MAOI. This combination can lead to serious interactions. The following products contain dextromethorphan and carry this warning:

  • Rompe Pechito

  • Walgreen Adult Cough Plus Chest Congestion Dm

  • Vicks Formula 44dm

  • Bio-Z-Cough

  • Childrens Mucus and Cough Relief

  • Guaifenesin and Dextromethorphan Hbr

  • Cough and Chest Congestion Dm

  • Maximum Strength Adult Cough Plus Chest Congestion Dm

  • Geri-Tussin

  • Guaiasorb

  • Mucus Relief Dm Max

  • Cvs Mucus Relief Dm

  • Vanacof Xp Cough / Chest Congestion

  • Mucinex Fast-Max Severe Congestion and Cough

  • Guaifenesin and Dextromethorphan Hydrobromide

  • Daytime Cough and Chest Congestion Dm

  • Vicks Dayquil Kids

  • Tussin Cough and Chest Congestion

  • Mucus Relief Dm Extended Release Caplets

  • Dr Kids

  • Giltuss Hbp Cough and Chest Congestion

  • Robafen Dm Cough

  • Robitussin Maximum Strength Cough Plus Chest Congestion Dm

  • Giltuss Diabetic

  • Giltuss Honey Cough and Chest Congestion

  • Giltuss Childrens Cough and Chest Congestion

  • Mucus Relief Dm

  • Mucus Relief Dm Honey and Berry Flavor

  • Mucus Relief Dm Extended Release Caplets

  • Mucus Relief Dm Max

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  • **Mucus

Pediatric Use

Pediatric patients may require specific dosing and precautions when using cough and chest congestion medications.

Efficacy and Dosing

  • Children 6 to under 12 years:

    • Rompe Pechito: 5 mL every 4 hours.

    • Vicks Formula 44dm: 15 mL every 4 hours.

    • Childrens Mucus and Cough Relief: 5-10 mL every 4 hours.

    • Giltuss Honey Cough and Chest Congestion: 5 mL every 4 hours.

    • Dr Kids: 1-2 vials every 4 hours.

    • Target Childrens Cough Relief: 5-10 mL every 4 hours.

    • Childrens Robitussin Elderberry Cough and Chest Congestion Dm: 10 mL every 4 hours.

    • Walgreens Daytime: 10 mL every 4 hours.

    • Limpia Pecho: 5 mL every 4 hours.

    • Giltuss Childrens Cough and Chest Congestion: 5 mL every 4 hours.

  • Children 4 to under 6 years:

    • Rompe Pechito: 2.5 mL every 4 hours.

    • Childrens Mucus and Cough Relief: 2.5-5 mL every 4 hours.

    • Giltuss Honey Cough and Chest Congestion: 2.5 mL every 4 hours.

    • Dr Kids: 1 vial every 4 hours.

    • Walgreens Daytime: 5 mL every 4 hours.

    • Childrens Robitussin Elderberry Cough and Chest Congestion Dm: 5 mL every 4 hours.

  • Children under 4 years:

    • Consult a doctor before use for all products listed.

Safety and Precautions

  • Contraindications: Do not use in children who are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug.

  • Consult a physician before use if the child has:

    • A cough that occurs with excessive phlegm (mucus).

    • A persistent or chronic cough, such as occurs with asthma.

  • Stop use and consult a physician if the cough lasts more than 7 days, returns, or is accompanied by fever, rash, or persistent headache.

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

General Warnings

  • Keep all medications out of reach of children.

  • Many products are not intended for use in children under 12 years of age; consult specific product labeling for age restrictions.

Geriatric Use

Geriatric patients may exhibit increased sensitivity to the side effects of various cough and chest congestion medications. While specific dosage adjustments or safety concerns for elderly patients are not consistently addressed across the product inserts, caution is advised due to the potential for reduced kidney function, which may necessitate modifications in dosing.

For products indicated for adults and children aged 12 years and over, such as Guaifenesin and Dextromethorphan formulations, it is important to consider that elderly patients may require closer monitoring. The absence of explicit geriatric use information in many inserts suggests a need for healthcare providers to exercise clinical judgment when prescribing these medications to older adults.

Overall, while no specific age cutoffs or dosage adjustments are universally recommended, healthcare professionals should remain vigilant regarding the unique pharmacokinetic and pharmacodynamic changes that may affect geriatric patients, particularly in the context of polypharmacy and comorbid conditions.

Pregnancy

The safety of various medications during pregnancy has not been fully established, and caution is advised for pregnant patients. Many products indicate that if a patient is pregnant or breastfeeding, they should consult a healthcare professional before use.

Potential risks to the fetus have been noted, particularly with certain medications, and further studies are needed to determine their safety profiles. For instance, some products explicitly state that there may be risks associated with their use during pregnancy, and it is recommended that pregnant patients only use these medications if clearly needed and after discussing with their healthcare provider.

No specific dosage modifications for pregnant individuals are generally provided across the reviewed products, emphasizing the importance of consulting a healthcare professional for personalized guidance.

In summary, pregnant patients should approach the use of these medications with caution, prioritize discussions with healthcare providers, and consider the potential risks to fetal outcomes before proceeding with treatment.

Lactation

Lactating mothers should consult a healthcare professional before using any of the products listed, as many of them do not provide specific warnings or recommendations regarding their use during breastfeeding.

While some products indicate that there is no information available about the potential for excretion in breast milk or associated risks to breastfed infants, caution is advised. For instance, certain formulations explicitly state that nursing mothers should seek professional advice before use, particularly those that may have a potential for excretion in breast milk.

The effects of these products on nursing infants are not well studied, and therefore, healthcare providers should be consulted to weigh the benefits against any potential risks. Overall, the general guidance across multiple labels emphasizes the importance of professional consultation for lactating mothers considering these medications.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosage adjustments and monitoring when using certain medications.

For several products, including Good Neighbor Sugar Free Adult Tussin DM, Equaline Mucus DM, and Maximum Strength Adult Cough Plus Chest Congestion DM, it is recommended that dosage adjustments be made based on creatinine clearance levels. Regular monitoring of renal function is advised, particularly for patients with moderate to severe renal impairment. Specifically, a reduced dose may be necessary for patients with a creatinine clearance of less than 30 mL/min, and special monitoring should be conducted for those with significant renal impairment to avoid potential toxicity.

Additionally, renal function tests should be performed prior to initiating therapy and periodically thereafter to ensure patient safety. This is particularly emphasized for products such as Mucus Relief DM and Tussin DM, where renal impairment may necessitate dosage adjustments.

In summary, patients with renal impairment should have their renal function closely monitored, and appropriate dosage adjustments should be made based on individual creatinine clearance levels to ensure safe and effective use of these medications.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of certain medications, necessitating careful consideration during treatment.

  • Dosage Adjustments: For patients with hepatic impairment, dosage adjustments may be required. Specifically, those with moderate to severe hepatic impairment may need a reduced dose or alternative therapy.

  • Monitoring Requirements: It is recommended that liver function tests be monitored regularly in patients with hepatic impairment. This monitoring should occur prior to and during treatment to assess liver function and adjust dosages as necessary.

  • Special Precautions: Caution should be exercised when prescribing medications to patients with liver problems. Special precautions should be taken to avoid potential adverse effects associated with altered drug metabolism.

Overall, healthcare providers should evaluate the individual patient's liver function and adjust treatment plans accordingly to ensure safety and efficacy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Symptoms of overdose may vary, but prompt medical attention is critical for both adults and children, even if no signs or symptoms are immediately apparent. It is essential to monitor for any unusual reactions or changes in condition following an overdose.

For specific products, the following actions are recommended:

  • Contact a Poison Control Center: This should be the first step in any suspected overdose situation.

  • Seek Medical Help: Immediate medical evaluation may be necessary to assess the severity of the overdose and to initiate appropriate treatment.

It is crucial to adhere to the recommended dosages to prevent the risk of overdose.

Nonclinical Toxicology

Teratogenic Effects

The available data indicate that several products advise consulting a healthcare professional if pregnant or breastfeeding before use. However, specific teratogenic effects have not been reported in animal studies for many formulations. Notably, some products explicitly state that no teratogenic effects were observed in animal studies, and no increase in fetal malformations was noted.

Non-Teratogenic Effects

There is a lack of specific information regarding non-teratogenic effects across the reviewed products. Most labels do not provide details on any non-teratogenic effects observed in animal studies.

Nonclinical Toxicology

The nonclinical toxicology sections of the reviewed products generally lack detailed information. Some products mention that studies in animals have not demonstrated adverse developmental outcomes, while others do not provide any specific nonclinical toxicology data.

Animal Pharmacology and Toxicology

Animal pharmacology and toxicology data are largely absent from the reviewed labels. Where available, some products indicate that they are well tolerated at effective doses for cough suppression and mucus relief. However, comprehensive animal studies detailing pharmacological effects or toxicological profiles are not provided in the majority of cases.

Storage and Handling

Products are supplied in various forms including liquid solutions, tablets, and syrups. The storage conditions and handling requirements are as follows:

  • Storage Temperature: Most products should be stored at room temperature, specifically between 20°C to 25°C (68°F to 77°F). Some products can be stored between 15°C to 30°C (59°F to 86°F). It is important to avoid refrigeration unless specified, as refrigeration may affect the product's efficacy.

  • Tamper-Evident Features: Many products include tamper-evident features. Users should not use the product if the security seal is broken, torn, or missing. This applies to both liquid and tablet forms.

  • Humidity and Heat Protection: Products should be kept in a dry place and protected from excessive heat and humidity. Avoid exposure to temperatures above 40°C (104°F) for optimal preservation.

  • Light Protection: Certain liquid products must be protected from light. It is recommended to store these in tight, light-resistant containers.

  • Dosing Cups: Some liquid products come with a dosing cup for accurate measurement. Users should retain this cup for use with the product.

  • Expiration Dates: Users should adhere to the expiration date indicated on the package and ensure proper storage conditions to maintain product integrity.

  • Disposal After Opening: For products that indicate, users should discard the product after opening if applicable, especially if tamper evidence is compromised.

By following these guidelines, users can ensure the safe and effective use of the products.

Product Labels

The table below lists all over-the-counter labels containing dextromethorphan hydrobromide and guaifenesin. Use it to compare dosage forms, strengths, and uses across products.

FDA-Approved Dextromethorphan hbr, guaifenesin Labels (Originator & Generics) showing branded and generic formulations with forms, routes, strengths, and FDA approval years.
More Details

Repacked & Relabeled Product Labels

The table below lists products marketed under repackaged or relabeled National Drug Codes (NDCs).

Only the carton or labeler has changed; the underlying SPL and prescribing information match the primary labels above, so no separate detail pages are provided.

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

FDA-Approved Dextromethorphan hbr, guaifenesin Repack / Relabels showing repack and relabel formulations with forms, routes, strengths, and FDA years.
Label
Forms
Routes
Strength range
FDA year
Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It consolidates data from 475 FDA Structured Product Labels (DailyMed) for Dextromethorphan Hbr, Guaifenesin (marketed as Rompe Pechito, Good Neighbor Sugar Free Adult Tussin Dm, Walgreen Adult Cough Plus Chest Congestion Dm), with data retrieved by a validated AI data-extraction workflow. This includes 475 distinct product formulations. All FDA-listed dosage forms and strengths are aggregated in the sections above. Regulatory status appears in the Summary Information panel and was verified in the FDA National Drug Code directory. Detailed product-specific information is available via the individual label pages linked above. No human clinician has reviewed this version.

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Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.