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Dextromethorphan hydrobromide/Guaifenesin/Phenylephrine hydrochloride

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Active ingredients
  • Guaifenesin 100 mg/15 mL – 400 mg
  • Dextromethorphan Hydrobromide 10 mg/15 mL – 29 mg
  • Phenylephrine Hydrochloride 5 mg/15 mL – 10 mg
Reference brand
Stona Cough
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage forms
  • Liquid
  • Solution
  • Solution/ Drops
  • Suspension
  • Suspension/ Drops
  • Syrup
  • Tablet
  • Tablet, Coated
  • Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2004
Label revision date
March 23, 2026
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Active ingredients
  • Guaifenesin 100 mg/15 mL – 400 mg
  • Dextromethorphan Hydrobromide 10 mg/15 mL – 29 mg
  • Phenylephrine Hydrochloride 5 mg/15 mL – 10 mg
Reference brand
Stona Cough
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage forms
  • Liquid
  • Solution
  • Solution/ Drops
  • Suspension
  • Suspension/ Drops
  • Syrup
  • Tablet
  • Tablet, Coated
  • Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2004
Label revision date
March 23, 2026
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Product Labels (141)
Product Labels (141)

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Drug Overview

Maximum Strength Severe Congestion and Cough is a medication designed to help relieve symptoms associated with colds, such as cough and nasal congestion. It works by loosening phlegm (mucus) and thinning bronchial secretions, making coughs more productive. The active ingredients include Dextromethorphan HBr, which acts as a cough suppressant; Guaifenesin, an expectorant that helps clear mucus; and Phenylephrine HCl, a nasal decongestant that alleviates nasal congestion.

This medication is suitable for adults and children aged 12 and older, providing temporary relief from cough due to minor throat and bronchial irritation, as well as reducing the intensity of coughing and the impulse to cough, which can help you sleep better. It is available in liquid form and is often compared to other well-known cold relief products.

Uses

This medication helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive by clearing the bronchial passageways. It is designed to temporarily relieve symptoms associated with the common cold, including cough due to minor throat and bronchial irritation, nasal congestion, and the intensity of coughing.

If you're experiencing a cough that disrupts your sleep or a stuffy nose, this medication can help reduce those symptoms, allowing for a more restful night. It is suitable for both adults and children, providing relief from the discomfort caused by colds and respiratory irritants.

Dosage and Administration

You should take the medication as directed, using only the dosing cup provided to measure your dose. For adults and children aged 12 years and older, the typical dosage is 20 mL every 4 hours, not exceeding 6 doses in a 24-hour period. If you are between 6 and 12 years old, take 10 mL every 4 hours, also not exceeding 6 doses in a day. For children aged 4 to under 6 years, the dose is 5 mL every 4 hours, while children under 4 years should not use this medication.

Always ensure you do not exceed the maximum number of doses specified, and consult a doctor if you have any questions or if the patient is under 2 years of age. Remember to shake the liquid well before use and keep the dosing cup with the product to avoid confusion with other medications.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) — a type of medication often prescribed for depression, psychiatric conditions, or Parkinson's disease — or if you have stopped taking an MAOI within the last two weeks. If you are unsure whether your medication contains an MAOI, please consult your doctor or pharmacist. Additionally, do not exceed the recommended dosage, and keep this product out of reach of children.

For children, do not use this product if they are taking an MAOI or if they are under 12 years of age. Always seek medical advice if symptoms persist or worsen, or if you experience nervousness, dizziness, or sleeplessness.

Side Effects

You may experience several side effects when using medications for severe congestion and cough. Common reactions include nervousness, dizziness, and sleeplessness. If these occur, or if your symptoms do not improve within 7 days or are accompanied by a fever, you should stop using the product and consult a doctor. Additionally, if your cough lasts more than 7 days, returns, or is accompanied by a fever, rash, or persistent headache, these could indicate a serious condition that requires medical attention.

Before using these medications, it's important to consult a doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate. You should also avoid using these products if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have recently stopped one, as this can lead to serious interactions. Always follow the recommended dosage and seek medical advice if you have any concerns.

Warnings and Precautions

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

  • Before using, ask a doctor if you have:

    • Heart disease

    • High blood pressure

    • Thyroid disease

    • Diabetes

    • Trouble urinating due to an enlarged prostate gland

    • A persistent or chronic cough (such as from smoking, asthma, chronic bronchitis, or emphysema)

    • A cough with excessive phlegm (mucus)

  • When using this product, do not exceed the recommended dosage.

  • Stop using and call your doctor if you experience:

    • Nervousness, dizziness, or sleeplessness

    • Symptoms that do not improve within 7 days or are accompanied by fever

    • A cough that lasts more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache. These could indicate a serious condition.

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

Overdose

In the event of an overdose of any cough or congestion medication, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Signs of an overdose may include severe dizziness, rapid heartbeat, and hallucinations. Always follow the recommended dosage instructions on the label to avoid serious adverse effects.

If you suspect an overdose, do not wait for symptoms to appear; act quickly to ensure safety. Remember, it's better to be cautious and seek help if you have any concerns about the amount taken.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult a healthcare professional before using any of the products listed. Many of these medications do not have established safety data for use during pregnancy, and there may be potential risks to the fetus. Always seek medical advice to ensure that the benefits of using a product outweigh any possible risks.

In general, if you are considering using a cough or cold medication, be aware that specific dosage modifications for pregnant individuals are often not provided. Therefore, discussing your options with a healthcare provider is crucial to ensure safe use during this time.

Lactation Use

If you are pregnant or breastfeeding, it is important to consult a healthcare professional before using any medication. Many products indicate that there are no specific warnings or recommendations for nursing mothers, and some do not provide information about whether the medication can pass into breast milk (excreted in breast milk) or its potential effects on your infant.

For certain medications, such as G-Supress Dx and Supress Dx Pediatric Drops, caution is advised due to the potential for excretion in breast milk, and the effects on nursing infants are not well studied. Always weigh the risks and benefits with your healthcare provider to ensure the safety of both you and your baby.

Pediatric Use

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

  • Children under 2 years: Do not use most of these products without consulting a doctor.

  • Children 2 to under 6 years: Dosages typically range from 1 mL to 5 mL every 4 hours, depending on the specific product. Always measure with the dosing device provided and do not exceed 6 doses in 24 hours.

  • Children 6 to under 12 years: Dosages generally range from 5 mL to 15 mL every 4 hours. Again, do not exceed 6 doses in 24 hours.

  • General precautions: Do not use these medications if your child is taking a monoamine oxidase inhibitor (MAOI) or has certain health conditions (like heart disease, high blood pressure, or diabetes) without consulting a doctor. If symptoms persist for more than 7 days, or if your child experiences nervousness, dizziness, or sleeplessness, seek medical advice immediately. Always keep medications out of reach of children and contact a Poison Control Center in case of overdose (1-800-222-1222).

Geriatric Use

When considering medications for older adults, it's important to note that many products do not provide specific information regarding their use in this population. For instance, several cough and cold medications, including various syrups and liquids, lack guidelines on dosage adjustments or safety precautions for elderly patients.

If you are an older adult or a caregiver, always consult a healthcare professional before using any medication, especially if you have underlying health conditions such as heart disease, high blood pressure, diabetes, or prostate issues. Be cautious about potential side effects, and do not exceed the recommended dosage. If symptoms persist for more than seven days or are accompanied by fever, rash, or severe headache, seek medical advice promptly.

Renal Impairment

When dealing with medications, it's important to be aware of how kidney health can affect their use. For some products, such as certain cold and cough syrups, renal impairment may require dosage adjustments. If you have reduced kidney function, your healthcare provider may recommend closer monitoring of your renal function through regular tests, especially if your creatinine clearance is low. This is crucial to ensure that the medication is safe and effective for you.

For many other medications, there is no specific information provided regarding renal impairment, dosage adjustments, or monitoring. If you have kidney issues, it's always best to consult with your healthcare provider before starting any new medication to ensure it is appropriate for your condition.

Hepatic Impairment

When considering medications for cough and congestion, it's important to be aware of how liver health can impact their use. For most products listed, there is no specific information regarding dosage adjustments or monitoring for individuals with liver problems. However, one product does advise consulting a doctor if you have liver disease, as hepatic impairment (the liver's reduced ability to function) may affect how the medication works in your body.

If you have liver issues, it's wise to discuss your condition with a healthcare professional before using these medications, as they may require special consideration or adjustments to ensure your safety and effectiveness of treatment.

Drug Interactions

It's crucial to be cautious when using certain cough and cold medications, especially if you are taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often used to treat depression and other mental health conditions. You should not use these medications if you are currently on an MAOI or for two weeks after stopping it, as this can lead to serious interactions that may affect your health.

Before using any cough or cold product, it's important to consult with your doctor or pharmacist, especially if you are taking other medications, such as nasal decongestants or stimulants, as these can increase the risk of side effects. Always prioritize your safety by discussing your current medications and health conditions with a healthcare professional.

Storage and Handling

To ensure the effectiveness and safety of your medication, store it at a controlled room temperature between 15°C and 30°C (59°F to 86°F). Avoid refrigeration, as it can compromise the product. Keep the container tightly closed and protect it from excessive heat and humidity. Always check the safety seal before use; do not use the product if the seal is broken or missing.

When disposing of the medication, follow local guidelines for hazardous waste. If the product is expired or no longer needed, discard it safely to prevent accidental ingestion, especially by children. Always use the dosing cup provided for accurate measurement.

Uses and Indications

This drug is indicated for the temporary relief of cough and nasal congestion associated with the common cold, hay fever, or other upper respiratory allergies. It helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive.

Indications

  • Cough Relief:

    • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants.

    • Reduces the intensity of coughing and the impulse to cough, aiding in sleep.

  • Nasal Congestion:

    • Temporarily relieves nasal congestion due to the common cold or hay fever.

    • Promotes nasal and/or sinus drainage and reduces swelling of nasal passages.

Usage Notes

  • This drug is effective in helping to loosen phlegm and thin bronchial secretions, facilitating the clearance of mucus from the bronchial passageways.

  • It is suitable for both adults and children, with specific formulations available for pediatric use.

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

Limitations of Use

  • The drug should be used as directed and is not intended for prolonged use without medical supervision.

Dosage and Administration

Adults and children 12 years of age and older are recommended to take 20 mL (4 teaspoons) every 4 hours, not to exceed 6 doses in a 24-hour period. For children aged 6 to under 12 years, the dosage is 10 mL (2 teaspoons) every 4 hours, also not to exceed 6 doses in a 24-hour period. Children aged 4 to under 6 years should receive 5 mL (1 teaspoon) every 4 hours, while those aged 2 to under 4 years should take 2.5 mL (1/2 teaspoon) every 4 hours. Children under 2 years of age should consult a doctor before use.

It is essential to measure the dosage using the dosing cup or device provided with the product, and this cup should not be used with any other products. The liquid formulation should be shaken well before use. This product is not intended for use in children under 12 years of age, and care should be taken to adhere to the recommended dosages to avoid exceeding the maximum daily limit.

Contraindications

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 uncertain whether a prescription drug contains an MAOI, consult a doctor or pharmacist before use.

In children, do not use in those taking a prescription MAOI or for 2 weeks after stopping the MAOI drug. Additionally, do not use for children under 12 years of age unless directed by a healthcare professional.

Do not use if the patient has heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland unless directed by a doctor. Avoid use for persistent or chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, unless directed by a healthcare professional.

For products intended for children, do not use in children under 2 years of age unless directed by a healthcare professional.

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.

General Precautions

Consult a doctor before use if any of the following conditions apply:

  • Heart disease

  • High blood pressure

  • Thyroid disease

  • Diabetes

  • Difficulty urinating due to an enlarged prostate gland

  • Persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema

  • Cough that occurs with excessive phlegm (mucus)

Dosage and Administration

When using this product, do not exceed the recommended dosage.

Stop Use and Call Your Doctor

Stop use and consult a doctor if:

  • Nervousness, dizziness, or sleeplessness occurs

  • Symptoms do not improve within 7 days or are accompanied by fever

  • Cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Emergency Medical Help

In case of overdose, seek medical help or contact a Poison Control Center immediately (1-800-222-1222).

Side Effects

Patients using products containing dextromethorphan, guaifenesin, and phenylephrine should be aware of the following adverse reactions:

Serious Adverse Reactions

  • Nervousness, Dizziness, or Sleeplessness: Patients should discontinue use and consult a doctor if these symptoms occur.

  • Persistent Cough: A cough lasting more than 7 days, recurring cough, or cough accompanied by fever, rash, or persistent headache may indicate a serious condition and requires medical attention.

  • Symptoms Not Improving: If symptoms do not improve within 7 days or are accompanied by fever, patients should seek medical advice.

Warnings

  • Monoamine Oxidase Inhibitors (MAOIs): Do not use if currently taking a prescription MAOI or within 2 weeks of stopping such medication. If unsure whether a prescription contains an MAOI, consult a healthcare professional.

  • Pre-existing Conditions: Patients should consult a doctor before use if they have:

    • Heart disease

    • High blood pressure

    • Thyroid disease

    • Diabetes

    • Difficulty urinating due to an enlarged prostate gland

    • Chronic cough associated with excessive phlegm (mucus) or conditions such as asthma, chronic bronchitis, or emphysema.

Additional Considerations

  • Dosage: Patients should not exceed the recommended dosage.

  • Pregnancy and Breastfeeding: Consult a healthcare professional if pregnant or breastfeeding before use.

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

Common Adverse Reactions

  • Nervousness, Dizziness, or Sleeplessness: These symptoms may occur and should be monitored.

  • Cough: A cough that lasts more than 7 days or is accompanied by fever, rash, or persistent headache should prompt a consultation with a healthcare provider.

Patients are advised to remain vigilant for these adverse reactions and to seek medical advice as necessary.

Drug Interactions

The use of products containing dextromethorphan or other active ingredients in the presence of a prescription monoamine oxidase inhibitor (MAOI) is contraindicated. Specifically, it is advised not to use these products if currently taking an MAOI or for two weeks after discontinuing the MAOI, as this may lead to serious interactions.

Contraindications Related to MAOIs

  • Monoamine Oxidase Inhibitors (MAOIs): All products listed indicate a significant risk of serious interactions when used concurrently with MAOIs. This includes:

    • Maximum Strength Severe Congestion and Cough

    • Tussi Pres

    • Tussin

    • Winco Foods Children's Multi Symptom Cold

    • Mucosan Multi-Symptom Honey

    • Mucosan Childrens Multi-Symptom Grape

    • Mucosan Severe Multi-Symptom

    • Mucosan Multi-Symptom Cherry

    • Bactimicina Cough and Cold

    • Vanacof Dm

    • Giltuss Childrens Cough and Cold

    • Giltuss Cough and Cold

    • Vicks Dayquil

    • Vicks Dayquil Kids

    • And many others.

Recommendations for Use

  • Consultation with Healthcare Professionals: It is recommended to consult a doctor or pharmacist before using these products if the patient is taking any other oral nasal decongestants, stimulants, sedatives, tranquilizers, or drugs for depression, particularly MAOIs. This is to avoid potential additive effects and increased risk of adverse reactions.

Lack of Drug Interaction Information

  • Several products do not provide specific drug interaction information. These include:

    • Desgen

    • Presgen Pediatric

    • Mucosan Multi-Symptom Honey

    • Fast Acting Mucus Relief

    • And others.

In summary, caution is advised when using these products in conjunction with MAOIs, and healthcare consultation is essential to ensure safe use.

Pediatric Use

Pediatric patients under 12 years of age should not use several products, including those labeled for adult use, as they are not intended for this age group.

Efficacy and Dosing

  • Children 6 to under 12 years:

    • Dosages vary by product:

      • 10 mL every 4 hours (e.g., Tussin, Giltuss, Altipres, and others).

      • 2 teaspoons (10 mL) every 4 hours (e.g., Presgen, Tussi Pres Pediatric).

      • 1 teaspoon (5 mL) every 4 hours (e.g., Desgen, Giltuss Childrens).

      • 15 mL every 4 hours (e.g., Vicks Dayquil Kids).

  • Children 4 to under 6 years:

    • Dosages typically include:

      • 5 mL every 4 hours (e.g., Giltuss, Altipres).

      • Consult a doctor for specific products.

  • Children 2 to under 4 years:

    • Dosages generally include:

      • 1 teaspoon (5 mL) every 4 hours (e.g., Tussi Pres Pediatric, Altipres).

      • Consult a doctor for specific products.

  • Children under 2 years:

    • Most products recommend consulting a doctor before use.

Safety and Cautions

  • Monoamine Oxidase Inhibitors (MAOIs):

    • Do not use in children taking MAOIs or within 2 weeks of stopping such medications.

  • Pre-existing Conditions:

    • Consult a doctor if the child has heart disease, high blood pressure, thyroid disease, diabetes, or chronic cough conditions (e.g., asthma).

  • Overdose:

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

General Recommendations

  • Measure doses using the dosing device provided with the product; do not use with other devices.

  • Do not exceed the recommended dosage of 6 doses in any 24-hour period.

  • If symptoms do not improve within 7 days or are accompanied by fever, rash, or persistent headache, consult a doctor.

Geriatric Use

No specific information regarding geriatric use, dosage adjustments, safety concerns, or special precautions for elderly patients is provided in the inserts for the majority of the products reviewed.

However, it is noted that elderly patients may have increased sensitivity to side effects, particularly with adult strength products. Healthcare professionals are advised to exercise caution and consider individual patient factors when prescribing these medications.

For products intended for adults, it is recommended that healthcare providers ask patients about pre-existing conditions such as heart disease, high blood pressure, diabetes, thyroid disease, or urinary issues related to an enlarged prostate gland before use. Additionally, patients should be instructed not to exceed the recommended dosage and to seek medical advice if they experience symptoms such as nervousness, dizziness, sleeplessness, or if their condition does not improve within a specified timeframe.

Overall, while specific geriatric considerations are lacking, vigilance in monitoring and patient-specific assessments are essential when treating elderly patients with these medications.

Pregnancy

Pregnant patients should exercise caution when considering the use of various cough and cold medications. For many products, including those labeled as Maximum Strength Severe Congestion and Cough, Tussi Pres, and Mucinex Fast-Max, it is advised that pregnant or breastfeeding individuals consult a healthcare professional prior to use.

The safety of several products, such as Winco Foods Children's Multi-Symptom Cold, Mucosan Children's Multi-Symptom Grape, and G-Supress Dx, during pregnancy has not been established. These products may pose potential risks to the fetus, and specific studies or data regarding their safety are lacking. It is recommended that pregnant patients discuss the use of these medications with their healthcare provider to weigh the potential benefits against the risks.

Certain products, including Dometuss-G and Tussin Cf, also lack specific information regarding safety during pregnancy, and healthcare provider consultation is strongly encouraged. Additionally, some formulations, such as those under the label of Signature Care and Congestion and Cough, explicitly state that use is not recommended during pregnancy due to potential risks to the fetus.

In summary, while many cough and cold medications do not provide specific contraindications, the general recommendation is for pregnant patients to seek professional medical advice before using these products to ensure the safety of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a healthcare professional before using any of the products listed, as many labels indicate the need for professional guidance during pregnancy and breastfeeding.

For several products, there are no specific warnings or recommendations regarding their use in nursing mothers, and no information is provided about the potential for excretion in breast milk or associated risks to breastfed infants. This includes products such as Desgen, Winco Foods Children's Multi Symptom Cold, and various formulations of Tussin and Mucosan.

However, caution is advised with certain products, such as G-Supress Dx and Supress Dx Pediatric Drops, which indicate a potential for excretion in breast milk. The effects of these medications on nursing infants are not well studied, necessitating careful consideration of the risks versus benefits before administration.

Overall, while some products lack specific lactation-related data, the general recommendation remains to seek professional advice to ensure the safety of both the lactating mother and her infant.

Renal Impairment

Patients with renal impairment may require careful consideration when using certain medications. For some products, such as those listed under labels 8, 31, 118, and 137, dosage adjustments may be necessary for individuals with reduced renal function. Specifically, patients with significant renal impairment should be closely monitored, and renal function tests should be performed regularly to assess kidney health.

In particular, for patients with reduced creatinine clearance, a reduced dose is recommended to mitigate the risk of potential toxicity. Special monitoring is advised for these patients to ensure safety and efficacy. However, it is important to note that many other products do not provide specific information regarding renal impairment, dosage adjustments, or monitoring requirements. Therefore, healthcare providers should exercise caution and consider individual patient circumstances when prescribing these medications to patients with kidney problems.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the drug. It is advised that dosage adjustments may be necessary for these patients. Regular monitoring of liver function tests is recommended, particularly for those with pre-existing liver conditions. Caution should be exercised when prescribing to patients with significant hepatic impairment, and a reduced dose should be considered for those with moderate to severe hepatic impairment.

For most products reviewed, there is no specific information regarding dosage adjustments, special monitoring, or precautions for patients with liver problems provided in the drug inserts. However, it is essential for healthcare providers to assess each patient's liver function and adjust treatment accordingly.

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 can include severe dizziness, rapid heartbeat, and hallucinations. It is crucial to monitor for these symptoms and any other unusual reactions following an overdose.

For all products listed, the recommendation is to adhere strictly to the prescribed dosage and not exceed the maximum indicated amount. In cases of accidental overdose, professional help should be sought immediately to mitigate potential adverse effects.

Nonclinical Toxicology

Teratogenic Effects

The use of various formulations is cautioned against during pregnancy or breastfeeding, with recommendations to consult a health professional prior to use. This advisory is consistent across multiple products, indicating a potential concern regarding teratogenic effects, although specific data on teratogenicity is not provided for most formulations.

Non-Teratogenic Effects

No specific non-teratogenic effects have been mentioned in the available data for the majority of the products reviewed.

Nonclinical Toxicology

There is a lack of detailed nonclinical toxicology information provided for the reviewed products. Most labels do not include specific findings or data related to nonclinical toxicology.

Animal Pharmacology and Toxicology

The reviewed products do not present specific details regarding animal pharmacology and toxicology. There is a general absence of information on animal studies or pharmacological effects in animal models across the various formulations.

Storage and Handling

The products are supplied in various forms including liquid, solution, syrup, and tablet configurations.

All products should be stored at controlled room temperature, typically between 15°C to 30°C (59°F to 86°F), unless otherwise specified. Some products have specific temperature ranges, such as 20°C to 25°C (68°F to 77°F) or 25°C (77°F) with permissible excursions.

It is essential to avoid refrigeration for all products, as this may affect their efficacy. Additionally, products should be protected from excessive heat and humidity to maintain their integrity.

For safety, users should not use any product if the safety seal is torn, broken, or missing. Dosing cups are provided with several liquid formulations to ensure accurate measurement.

Containers should be kept tightly closed when not in use, and products should be discarded after opening if applicable. Users are advised to check expiration dates and lot numbers as indicated on the packaging.

Product Labels

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

FDA-Approved Dextromethorphan hbr, guaifenesin, and phenylephrine hcl Labels (Originator & Generics) showing branded and generic formulations with forms, routes, strengths, and FDA approval years.
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Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It consolidates data from 141 FDA Structured Product Labels (DailyMed) for Dextromethorphan Hbr, Guaifenesin, and Phenylephrine Hcl (marketed as Maximum Strength Severe Congestion and Cough, Actidom Dmx, Tussi Pres), with data retrieved by a validated AI data-extraction workflow. This includes 141 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.