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Dr. Sana Cough and Chest Congestion Dm Sugar Free

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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
Syrup
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
July 23, 2025
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
Syrup
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2025
Label revision date
July 23, 2025
Manufacturer
GADAL Laboratories, Inc
Registration number
M012
NDC root
53113-515

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

Drug Overview

This medication is designed to temporarily relieve cough caused by minor irritation in your 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. This means that it can help you clear mucus from your airways more effectively, providing some comfort during your illness.

Uses

You can use this medication to temporarily relieve a cough caused by minor irritation in your throat and bronchial tubes, which often happens with the common cold. It also helps to loosen phlegm (mucus) and thin out bronchial secretions, making your coughs more productive. This means that when you do cough, it can help clear out mucus more effectively, providing some relief from discomfort.

Dosage and Administration

Before using this medication, make sure to shake the bottle well to ensure the ingredients are mixed properly. For adults and children aged 12 years and older, the recommended dosage is 2 tablespoons, which is equivalent to 30 milliliters (mL), taken every 4 hours. However, it's important not to exceed more than 6 doses within a 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, as it may differ from the adult recommendation. Always follow your healthcare provider's guidance 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 ensure their safety. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center for assistance.

Currently, there are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication. However, always use it responsibly and follow any additional guidance provided by your healthcare professional.

Side Effects

You should be aware of some important warnings and potential side effects when using this medication. Avoid using it if you are currently taking 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. It's advisable to consult your doctor before using this medication if you have a cough with excessive mucus, or if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema.

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 consult your doctor, as these could be signs of a more serious condition. Additionally, if you are pregnant or breastfeeding, it's important to seek advice from 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 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.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always keep emergency contact information handy and be aware of the steps to take in case of an overdose. Your health is important, and getting prompt assistance is key.

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

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always ensure that your healthcare provider is aware of your age and any existing health conditions, as they can provide personalized advice and monitor for any potential issues. Your safety and well-being are the top priority.

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 change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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, certain 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.

Always discuss your current medications with your healthcare provider or pharmacist to ensure your safety. If you're unsure whether your prescription includes an MAOI, don't hesitate to ask for clarification. Your health and well-being are the top priority, and open communication with your healthcare team is essential.

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°F 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 seal under the cap is torn, broken, or missing, do not use the product, as this could indicate that it has been compromised. Following these guidelines will help you use the product safely and effectively.

Additional Information

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

FAQ

What is the purpose of this medication?

This medication temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold and helps loosen phlegm (mucus) to make coughs more productive.

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

Adults and children 12 years and older should take 2 tablespoons (30 mL) every 4 hours, not exceeding 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 this medication if your cough is accompanied by excessive phlegm (mucus).

Are there any warnings I should be aware of?

Do not use this medication if you are currently 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 immediately.

Is this medication safe to use during pregnancy or breastfeeding?

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

How should I store this medication?

Store the medication between 15°C to 30°C (59°F to 86°F) and do not use it if the seal under the cap is torn, broken, or missing.

Packaging Info

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

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

Drug Information (PDF)

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

View product document (PDF)

Description

Cough and chest congestion are common symptoms associated with respiratory conditions. This formulation is designed to alleviate these symptoms, providing relief from cough and reducing chest congestion. The active ingredients work synergistically to target the underlying causes of discomfort, promoting easier breathing and improved respiratory function. The product is available in a suitable dosage form for effective administration.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and older are advised to administer 2 tablespoons (30 mL) every 4 hours as needed. It is important to note that no more than 6 doses should be given within a 24-hour period. For children under 12 years of age, consultation with a healthcare professional is recommended prior to administration.

Prior to use, the solution must be shaken well to ensure proper mixing.

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

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

Healthcare providers should be consulted prior to use if the patient presents with a cough that is associated with excessive phlegm (mucus) or if the cough is persistent or chronic, as seen in conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Patients should be advised to discontinue use and seek medical attention 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 an underlying serious condition that requires further evaluation.

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

General precautions include keeping this product out of reach of children to prevent accidental ingestion.

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

Patients should be reminded to stop taking the product and consult their doctor if the cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache.

Side Effects

Patients should be aware of the following warnings and adverse reactions associated with the use of this medication. It is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as this may lead to serious interactions.

Before using this medication, patients should consult a healthcare professional if they have a cough that is accompanied by excessive phlegm (mucus) or if they experience a persistent or chronic cough, which may occur in conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Patients are advised to discontinue use and seek medical advice if their cough persists for more than one week, tends to recur, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires further evaluation.

Additionally, pregnant or breastfeeding patients should consult their healthcare provider prior to use to ensure safety for both themselves and their 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 within 2 weeks of discontinuing an MAOI. It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to confirm whether their current prescription includes 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 Sugar Free (dextromethorphan hydrobromide, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dr. Sana Cough and Chest Congestion Dm Sugar Free.
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 in any 24-hour period. Caution is advised to ensure that the dosage does not exceed the specified limits.

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 they may have altered pharmacokinetics and pharmacodynamics. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to ensure safe use during pregnancy and lactation.

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 individuals.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 aware that the symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is vital for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

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

The product is supplied in a configuration that includes a tamper-evident feature. It is essential to inspect the seal under the cap before use; the product should not be utilized if the seal is torn, broken, or missing.

For optimal storage, the product must be kept within a temperature range of 15°C to 30°C (59°F to 86°F). Proper adherence to these storage conditions is crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

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

Drug Information (PDF)

This file contains official product information for Dr. Sana Cough and Chest Congestion Dm Sugar Free, 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 Sugar Free, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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

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

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