Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Dr. Sana Cough and Chest Congestion Dm

Last content change checked dailysee data sync status

Active ingredients
  • Guaifenesin 200 mg/30 mL
  • Dextromethorphan Hydrobromide 20 mg/30 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
July 22, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 200 mg/30 mL
  • Dextromethorphan Hydrobromide 20 mg/30 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
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 2025
Label revision date
July 22, 2025
Manufacturer
GADAL Laboratories, Inc
Registration number
M012
NDC root
53113-514
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

CONGESTION DM is a medication designed to temporarily relieve cough caused by minor irritation in the throat and bronchial tubes, which can happen with the common cold. It works by helping to loosen phlegm (mucus) and thin bronchial secretions, making your coughs more productive and easier to manage.

If you're dealing with a cough and congestion, CONGESTION DM may provide the relief you need to feel more comfortable.

Uses

If you're dealing with a cough caused by minor irritation in your throat or bronchial tubes, especially from a common cold, this medication can provide temporary relief. It works by soothing your throat and reducing the urge to cough.

Additionally, this medication helps to loosen phlegm (mucus) and thin out bronchial secretions. This makes your coughs more productive, allowing you to clear out mucus more effectively.

Dosage and Administration

Before using this medication, make sure to shake the bottle well to ensure the ingredients are properly mixed. If you are an adult or a child aged 12 years and older, you should take 2 tablespoons (30 mL) every 4 hours as needed. However, it’s important not to exceed more than 6 doses in any 24-hour period to avoid potential side effects.

If you have a child under 12 years of age, it’s crucial to consult your doctor for the appropriate dosage and guidance. Always follow your healthcare provider's instructions to ensure safe and effective use of the medication.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center for assistance.

While there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication, always use it responsibly and as directed. Your safety is paramount, so please follow these guidelines closely.

Side Effects

You should be aware of some important warnings and potential side effects when using this medication. It is crucial not to take it if you are currently using a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication for depression or certain other conditions, or if you have stopped taking an MAOI within the last two weeks. If you have a cough that produces a lot of mucus or a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, consult your doctor before using this medication.

If your cough lasts more than a week, keeps coming back, or is accompanied by a fever, rash, or persistent headache, you should stop using the medication and seek medical advice, as these could be signs of a more serious issue. Additionally, if you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this medication.

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. Additionally, if you have a cough with excessive mucus or a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, it's important to talk to your doctor before using this product.

Keep this medication out of reach of children. If you experience an overdose, seek emergency medical help or contact a Poison Control Center immediately. You should also stop using the product and call your doctor if your cough lasts more than a week, keeps coming back, or is accompanied by a fever, rash, or persistent headache, as these could be signs of a more serious condition. If you are pregnant or breastfeeding, consult a healthcare professional before use.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you would typically experience with the medication.

Always err on the side of caution—if you notice anything concerning, don’t hesitate to reach out for assistance. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with your healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with your 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

If you have a child under 12 years old, it's important to consult your doctor before using this medication. For children aged 12 and older, the recommended dosage is 2 tablespoons (30 mL) every 4 hours, but be sure not to exceed 6 doses in a 24-hour period. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to be adjusted based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific condition. They can help monitor your kidney health and make any necessary changes to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to be cautious about combining medications. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric conditions, or Parkinson's disease, you should not use this product. Additionally, you should wait at least two weeks after stopping an MAOI before starting this medication. If you're unsure whether your current prescription includes an MAOI, please consult your doctor or pharmacist for clarification.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potentially harmful interactions. Your health is a priority, and your provider can help you navigate any concerns.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a temperature between 15°C to 30°C (59° to 86°F). This temperature range helps maintain the product's effectiveness.

When handling the product, be sure to check the tamper-evident feature. If the imprinted cello-band over the cap is torn, broken, or missing, do not use the product, as this indicates it may have been compromised. Following these guidelines will help you use the product safely and effectively.

Additional Information

You can take this medication orally. For adults and children aged 12 years and older, the recommended dose is 2 tablespoons (30 mL) every 4 hours. If the patient is under 12 years old, it's important to consult your doctor for the appropriate dosage.

FAQ

What is CONGESTION DM used for?

CONGESTION DM temporarily relieves cough due to minor throat and bronchial irritation, helping to loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

What is the recommended dosage for adults and children 12 years and older?

The recommended dosage is 2 tablespoons (30 mL) every 4 hours, with a maximum of 6 doses in any 24-hour period.

What should I do if I have a cough with excessive phlegm?

You should ask a doctor before using CONGESTION DM if you have a cough accompanied by excessive phlegm (mucus) or a persistent cough.

Are there any warnings associated with CONGESTION DM?

Do not use CONGESTION DM if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor if your cough persists for more than 1 week or is accompanied by a fever, rash, or persistent headache.

What should I do in case of an overdose?

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

Can I use CONGESTION DM if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using CONGESTION DM.

What should I do if I have children under 12 years of age?

Consult your doctor before using CONGESTION DM for children under 12 years of age.

How should I store CONGESTION DM?

Store CONGESTION DM between 15°C to 30°C (59° to 86°F) and do not use it if the tamper-evident feature is broken or missing.

Packaging Info

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

Packaging configurations for Dr. Sana Cough and Chest Congestion Dm.
Details

Drug Information (PDF)

This file contains official product information for Dr. Sana Cough and Chest Congestion Dm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Congestion DM is a pharmaceutical formulation indicated for the relief of nasal congestion. It is composed of active ingredients that work synergistically to alleviate symptoms associated with upper respiratory tract conditions. The product is available in a dosage form suitable for oral administration. The specific chemical composition and molecular weight are proprietary to the formulation. The appearance of Congestion DM is consistent with standard pharmaceutical practices, ensuring quality and efficacy in its intended use.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with the common cold. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby making coughs more productive.

Limitations of Use: This medication is intended for symptomatic relief and does not address the underlying causes of cough associated with respiratory infections.

Dosage and Administration

Healthcare professionals should advise patients to shake the product well before use. For adults and children aged 12 years and older, the recommended dosage is 2 tablespoons (30 mL) every 4 hours, not to exceed 6 doses within a 24-hour period. For children under 12 years of age, it is essential to consult a physician for appropriate dosing recommendations.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Contraindications This product must not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should be consulted if there is uncertainty regarding the presence of an MAOI in any prescription medication.

Cough Considerations Healthcare professionals should be consulted prior to use if the patient has a cough that is accompanied by excessive phlegm (mucus) or if the cough is persistent or chronic, as seen in conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Monitoring Symptoms Patients should be advised to discontinue use and seek medical advice if the cough persists for more than one week, recurs, or is accompanied by additional symptoms such as fever, rash, or persistent headache. A persistent cough may indicate a serious underlying condition that requires further evaluation.

Pregnancy and Breastfeeding For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional before using this product.

Pediatric Use This product should be kept out of reach of children to prevent accidental ingestion.

Emergency Situations In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center should be established without delay.

These precautions are critical for ensuring patient safety and effective use of the product.

Side Effects

Patients should be aware of several important warnings associated with the use of this medication. It is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain drugs prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, the medication should not be used for at least two weeks after discontinuing an MAOI.

Patients are advised to consult a healthcare professional prior to use if they have a cough that is accompanied by excessive phlegm (mucus) or if they experience a persistent or chronic cough, such as those associated with smoking, asthma, chronic bronchitis, or emphysema.

Furthermore, patients should discontinue use and seek medical advice if their cough persists for more than one week, tends to recur, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional before using this medication to ensure safety for both the patient and the child.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson's disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription medication contains an MAOI before initiating treatment with this product.

Packaging & NDC

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

Packaging configurations for Dr. Sana Cough and Chest Congestion Dm.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 tablespoons (30 mL) every 4 hours, with a maximum of 6 doses within a 24-hour period.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions 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 available 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 in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by the severity of symptoms and the clinical judgment of the healthcare provider. Supportive care and symptomatic treatment may be necessary, and the involvement of poison control experts can provide additional guidance on the appropriate management strategies.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Furthermore, there is no information available related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

This product is supplied with a tamper evident feature; it should not be used if the imprinted cello-band over the cap is torn, broken, or missing.

Storage conditions require that the product be maintained at a temperature range of 15°C to 30°C (59°F to 86°F) to ensure its integrity and efficacy. Proper handling and storage are essential to preserve the quality of the product.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 tablespoons (30 mL) every 4 hours. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing guidance. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Dr. Sana Cough and 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 Dr. Sana Cough and 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.

Learn more in our Editorial Policy

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.