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Creomulsion

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Active ingredient
Dextromethorphan Hydrobromide 20 mg/15 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Syrup
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
February 17, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dextromethorphan Hydrobromide 20 mg/15 mL
Other brand names
Drug classes
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
February 17, 2026
Manufacturer
Socius Care, LLC
Registration number
M012
NDC root
70893-0011
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

Creomulsion Cough Medicine is a soothing cough suppressant designed to help relieve your cough. It works by temporarily calming the cough control center in your brain, which can provide relief from coughing caused by minor throat and bronchial irritation, such as that which may occur with a cold.

This medicine has a rich, traditional base that coats and soothes irritated membranes, and it is formulated without dyes, alcohol, or artificial sweeteners, making it a safe option for those seeking relief from persistent coughs.

Uses

If you're dealing with a cough caused by minor irritation in your throat and bronchial tubes, especially during a cold, this medication can help. It works by temporarily relieving that uncomfortable cough, allowing you to feel more at ease. Remember, it's designed for short-term relief, so you can get back to your daily activities without the distraction of a persistent cough.

Dosage and Administration

It's important to follow the correct dosage when using this medication to ensure your safety and effectiveness. For adults and children aged 12 years and older, you should take 15 mL (which is equivalent to 3 teaspoons) every 4 hours. However, make sure not to exceed 6 doses within a 24-hour period. To measure your dose accurately, use the enclosed dose cup.

If you have children under 12 years old, please do not use this medication for them. Always adhere to these guidelines to help manage your health effectively.

What to Avoid

It's important to be aware of certain guidelines when using this medication. You should stop using it and consult your doctor if your cough lasts more than 7 days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache. These could indicate a more serious health issue that needs attention.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always prioritize your health and seek medical advice if you have any concerns.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. If you are currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication for depression or certain other conditions, you should not use this product. Additionally, you should wait at least two weeks after stopping an MAOI before starting this medication.

If your cough lasts more than seven days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache, it’s important to stop using the medication and consult a doctor, as these could indicate a more serious health issue. You should also speak with a healthcare professional if your cough produces a lot of mucus or if you have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema.

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, certain psychiatric conditions, or Parkinson's disease. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

If your cough lasts more than seven days, returns, or is accompanied by a fever, rash, or persistent headache, stop using the product and contact your doctor. These symptoms could indicate a more serious health issue.

In the event of an overdose, it is crucial to seek emergency medical help or contact a Poison Control Center immediately. Your safety is important, so please take these precautions seriously.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect an overdose, it is important to be aware of potential signs, which may include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about an overdose, seek immediate medical help. Always contact your healthcare provider or local emergency services for guidance in such situations. Remember, it's better to be cautious and get checked if you think something might be wrong.

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

It is important to note that this medication is not recommended for children under 12 years of age. If you are a parent or caregiver, please ensure that your child meets this age requirement before considering this treatment. Always consult with a healthcare professional if you have any questions or concerns about the appropriate use of medications for your child.

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 any existing health conditions or medications, as this can help in making informed decisions about treatment options. Your safety and well-being are the top priority, so don’t hesitate to ask questions or express any concerns you may have.

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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to be cautious when taking Creomulsion Cough Medicine, especially if you are currently using a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks. Combining these medications can lead to serious interactions that may affect your health.

Always discuss any medications you are taking, including over-the-counter products like Creomulsion, with your healthcare provider. They can help ensure that your treatments are safe and effective, and they can provide guidance tailored to your specific health needs.

Storage and Handling

To ensure the best quality and safety of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its effectiveness. When you receive the product, you'll notice it comes with a tamper-evident seal under the cap, which is an important safety feature. This seal indicates that the product has not been opened or altered, so be sure to check it before use.

Handle the product carefully to avoid any damage. Always keep it in a clean environment to maintain its integrity. If you have any questions about disposal or further handling instructions, please refer to the guidelines provided with your product.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dose is 15 mL (which is equivalent to 3 teaspoons) every 4 hours. However, this medication is not recommended for children under 12 years of age. If you have any questions about how to use this medication, be sure to consult with your healthcare provider.

FAQ

What is Creomulsion Cough Medicine?

Creomulsion Cough Medicine is a cough suppressant that temporarily calms the cough control center to relieve coughs. It has a rich base that coats and soothes irritated membranes and contains no dyes, alcohol, or artificial sweeteners.

How does Creomulsion Cough Medicine work?

It works by temporarily calming the cough control center to relieve coughs caused by minor throat and bronchial irritation, such as that which may occur with a cold.

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

Adults and children 12 years and over should take 15 mL (3 teaspoons) every 4 hours, but do not exceed 6 doses in any 24-hour period.

Can children under 12 use Creomulsion Cough Medicine?

No, Creomulsion Cough Medicine should not be used by children under 12 years of age.

What should I do if my cough lasts more than 7 days?

You should stop using the medicine and ask a doctor if your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache, as these could indicate a serious condition.

Are there any contraindications for using Creomulsion Cough Medicine?

Yes, do not use it if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI, as this may lead to serious interactions.

What should I do in case of an overdose?

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

Is it safe to use Creomulsion Cough Medicine during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Creomulsion Cough Medicine.

What are the storage conditions for Creomulsion Cough Medicine?

Store Creomulsion Cough Medicine at 20-25°C (68-77°F) and ensure it is packaged with a tamper-evident seal under the cap.

Packaging Info

Below are the non-prescription pack sizes of Creomulsion (dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Creomulsion.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

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 a cold.

Limitations of Use: This medication is intended for short-term use and should not be used for persistent or chronic coughs without consulting a healthcare professional.

Dosage and Administration

Adults and children aged 12 years and older are advised to take 15 mL (3 teaspoons) every 4 hours as needed. It is imperative that no more than 6 doses are administered within a 24-hour period. The enclosed dose cup should be utilized for accurate measurement.

This medication is not recommended for use in children under 12 years of age.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use of this product is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription medication contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Healthcare professionals should advise patients to discontinue use and seek medical advice if a cough persists for more than seven days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. These symptoms may indicate the presence of a serious underlying condition that requires further evaluation.

In the event of an overdose, it is crucial to obtain emergency medical assistance immediately or contact a Poison Control Center. Prompt action is necessary to ensure patient safety and appropriate management of the situation.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions may occur, and patients are advised to discontinue use and consult a healthcare professional if they experience a cough that lasts more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache, as these symptoms could indicate a serious underlying condition.

Common adverse reactions may include cough associated with excessive phlegm (mucus) or chronic cough due to conditions such as smoking, asthma, chronic bronchitis, or emphysema. Patients should seek medical advice before using this product if they have a cough that is productive of excessive mucus or if they have a chronic cough.

Additionally, it is important to note that this product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing such medications. Patients uncertain about the presence of an MAOI in their prescription should consult a doctor or pharmacist prior to use.

Drug Interactions

The use of Creomulsion Cough Medicine is contraindicated in patients who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for a period of 2 weeks following the discontinuation of an MAOI. Co-administration may result in serious interactions that could pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified for Creomulsion Cough Medicine. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the aforementioned contraindication.

Packaging & NDC

Below are the non-prescription pack sizes of Creomulsion (dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Creomulsion.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. Safety and efficacy have not been established in this age group, and appropriate dosing guidelines are not available. Caution is advised when considering treatment options for pediatric patients.

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 potential 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health 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 outlined 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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on the clinical presentation.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has shown that the following adverse reactions may occur: allergic reactions, which include rash, pruritus, and urticaria. These events have been reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Additionally, healthcare providers should encourage patients to consult a doctor prior to use if they have a cough that is associated with excessive phlegm (mucus). It is also important to discuss the need for medical advice if the cough is chronic or associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Storage and Handling

The product is supplied with a tamper-evident seal under the cap, ensuring the integrity of the packaging. It should be stored at a controlled room temperature of 20-25°C (68-77°F) to maintain its efficacy and safety. Proper handling and storage conditions 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 15 mL (3 teaspoons) every 4 hours. It is contraindicated for use in children under 12 years of age. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Creomulsion, 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 Creomulsion, 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

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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.