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Cosedal Drops

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Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 10 mg/5 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 2012
Label revision date
July 22, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 10 mg/5 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 2012
Label revision date
July 22, 2025
Manufacturer
Menper Distributors, Inc.
Registration number
M012
NDC root
53145-059
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

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

If you're experiencing a cough due to a cold, Cosedal Drops may provide the relief you need by addressing the irritation and helping clear mucus from your airways.

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 it can help you clear out mucus more effectively when you're feeling under the weather.

Dosage and Administration

When taking this medication, it's important to follow the correct dosage based on age. If you are 12 years old or older, you should take 2 teaspoonfuls (10 mL) every 4 hours, but remember not to exceed 6 doses in a 24-hour period. For children aged 6 to under 12 years, the recommended dose is 1 teaspoonful (5 mL) every 4 hours.

For younger children, the dosage changes slightly: those aged 2 to under 6 years should take 1/2 teaspoonful (2.5 mL) every 4 hours. If your child is under 2 years old, it's best to consult your doctor for guidance on the appropriate dosage. Always ensure you stick to these guidelines to use the medication safely and effectively.

What to Avoid

You should avoid using this product if you have a persistent or chronic cough, which can occur with conditions like smoking, asthma, or emphysema, especially if your cough is accompanied by excessive mucus. It's important to consult your doctor before using this product in such cases. Additionally, do 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 psychiatric conditions, or for two weeks after stopping an MAOI. If you're unsure whether your medication contains an MAOI, please ask your doctor or pharmacist for clarification.

Side Effects

You should be aware that a persistent cough can indicate a serious health issue. If your cough lasts more than a week, keeps coming back, or is accompanied by symptoms like fever, rash, or a lasting headache, it’s important to consult a doctor. Taking these signs seriously can help ensure your health and well-being.

Warnings and Precautions

It's important to follow the recommended dosage when using this product. Taking more than the suggested amount can lead to serious issues. If you develop a persistent cough that lasts more than a week, keeps coming back, or is accompanied by symptoms like fever, rash, or a lasting headache, you should consult your doctor as this could indicate a more serious condition.

You should avoid using this product for chronic coughs related to smoking, asthma, or emphysema, especially if your cough produces a lot of mucus, unless your doctor advises otherwise. Additionally, do not use this product 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. If you're unsure whether your medication contains an MAOI, please ask your doctor or pharmacist for clarification.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

When giving medication to your child, it's important to follow the recommended dosages based on their age. For children aged 6 to under 12 years, the dosage is 1 teaspoonful (5 mL) every 4 hours. If your child is between 2 and under 6 years old, they should receive 1/2 teaspoonful (2.5 mL) every 4 hours.

For children under 2 years of age, you should consult your doctor before administering any medication. This ensures that you are providing the safest and most effective care for your little one. Always adhere to these guidelines to help keep your child healthy.

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. If you or a loved one is an older adult, it’s wise to discuss any medications with a healthcare provider, as they can help assess individual health needs and potential risks.

Always keep in mind that older adults may have different responses to medications, and factors like kidney function (renal impairment) and changes in cognitive abilities can affect how a drug works. Regular check-ins with your healthcare team can ensure that any treatment remains safe and effective.

Renal Impairment

If you have kidney 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 for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation and any other health factors you may have.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver condition. They can help monitor your liver function and make any necessary adjustments to your treatment plan.

Drug Interactions

It's important to be cautious when taking this product, especially if you are currently using or have recently stopped a prescription monoamine oxidase inhibitor (MAOI). MAOIs are medications often prescribed for depression, certain psychiatric conditions, or Parkinson’s disease. You should not use this product while on an MAOI or for at least two weeks after stopping it. If you're unsure whether your medication includes an MAOI, please consult your doctor or pharmacist before proceeding.

Always discuss any medications or tests 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 regarding your treatments.

Storage and Handling

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

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Cosedal Drops used for?

Cosedal Drops temporarily relieve cough due to minor throat and bronchial irritation, as may occur with the common cold, and help loosen phlegm (mucus) to make coughs more productive.

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

For adults and children 12 years of age and over, the recommended dosage is 2 teaspoonfuls (10 mL) every 4 hours, not exceeding 6 doses in 24 hours.

What dosage should children aged 6 to under 12 take?

Children aged 6 to under 12 years should take 1 teaspoonful (5 mL) every 4 hours.

What dosage is recommended for children aged 2 to under 6?

Children aged 2 to under 6 years should take 1/2 teaspoonful (2.5 mL) every 4 hours.

What should I do if my child is under 2 years old?

If your child is under 2 years of age, you should consult your doctor before use.

Are there any contraindications for using Cosedal Drops?

Yes, do not use Cosedal Drops for persistent or chronic cough, such as those caused by smoking, asthma, or emphysema, or if accompanied by excessive phlegm (mucus), unless directed by a doctor.

Can I use Cosedal Drops if I am taking a monoamine oxidase inhibitor (MAOI)?

No, you should not use Cosedal Drops if you are currently taking a prescription MAOI or for 2 weeks after stopping the MAOI drug.

What should I do if my cough persists?

If your cough persists for more than one week, tends to reoccur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

Is it safe to use Cosedal Drops during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Cosedal Drops.

How should I store Cosedal Drops?

Store Cosedal Drops between 15°-30°C (59°-86°F).

Packaging Info

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

Packaging configurations for Cosedal Drops.
Details

Drug Information (PDF)

This file contains official product information for Cosedal Drops, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Cosedal is presented in a liquid dosage form as drops. The formulation is designed for sublingual administration. The product is characterized by its clear, colorless appearance. The active ingredients and their concentrations are specified in the accompanying labeling. Inactive ingredients include a blend of excipients that facilitate the stability and delivery of the active components. The precise molecular weight and chemical formula are detailed in the product specifications.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with 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.

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

Dosage and Administration

For patients 12 years of age and older, the recommended dosage is 2 teaspoonfuls (10 mL) administered every 4 hours. For children aged 6 to under 12 years, the dosage is 1 teaspoonful (5 mL) every 4 hours. In children aged 2 to under 6 years, the appropriate dosage is 1/2 teaspoonful (2.5 mL) every 4 hours.

It is important to note that no more than 6 doses should be administered within a 24-hour period. For children under 2 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Contraindications

This product is contraindicated in patients with persistent or chronic cough, including coughs associated with smoking, asthma, or emphysema, or when cough is accompanied by excessive phlegm (mucus), unless directed by a healthcare professional.

Additionally, the use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare provider or pharmacist if uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

Patients should adhere strictly to the recommended dosage to avoid potential adverse effects. Exceeding the prescribed amount may lead to serious complications.

A persistent cough may indicate an underlying serious condition. If a cough persists for more than one week, recurs frequently, or is accompanied by symptoms such as fever, rash, or a persistent headache, it is imperative to consult a healthcare professional for further evaluation.

This product is not intended for the treatment of persistent or chronic coughs associated with smoking, asthma, or emphysema. Additionally, it should not be used if the cough is accompanied by excessive phlegm (mucus) unless directed by a healthcare provider.

Caution is advised for patients currently taking prescription monoamine oxidase inhibitors (MAOIs), which are used for the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease. This product should not be used concurrently with MAOIs or within two weeks of discontinuing such medication. Patients uncertain about the presence of an MAOI in their prescription should consult a healthcare professional or pharmacist prior to use.

Monitoring for these conditions and adherence to the outlined precautions is essential for the safe use of this product.

Side Effects

Patients should be aware that a persistent cough may indicate a serious underlying condition. If a cough persists for more than one week, tends to recur, or is accompanied by additional symptoms such as fever, rash, or a persistent headache, it is advised that they consult a healthcare professional for further evaluation.

Drug Interactions

The concomitant use of this product with 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 use this product while taking an MAOI or for a period 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 Cosedal Drops (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cosedal Drops.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 1 teaspoonful (5 mL) every 4 hours. For children aged 2 to under 6 years, the recommended dosage is 1/2 teaspoonful (2.5 mL) every 4 hours.

For infants and children under 2 years of age, it is advised to consult a healthcare professional before administration.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, 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, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

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

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose scenario.

Nonclinical Toxicology

If a patient is pregnant or breastfeeding, it is advised to consult a healthcare professional prior to use. There are no specific non-teratogenic effects or detailed nonclinical toxicology data available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion.

Patients should be informed that this product is not intended for use in cases of persistent or chronic cough, such as those associated with smoking, asthma, or emphysema, or if the cough is accompanied by excessive phlegm (mucus), unless directed by a healthcare professional.

Additionally, it is crucial to inform patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should also be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist before using this product.

Storage and Handling

This product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product within the temperature range of 15° to 30°C (59° to 86°F) to maintain its efficacy and stability. Proper storage conditions should be observed to ensure the integrity of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Cosedal Drops, 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 Cosedal Drops, 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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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.