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Creomulsion

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Active ingredient
Dextromethorphan Hydrobromide 5 mg/5 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 5 mg/5 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
70893-0012
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

Gentle Creomulsion For Children is a specially formulated medication designed for a child's delicate system. It contains a highly effective cough suppressant that is available without a prescription. This medication works by calming the urge to cough and has a smooth consistency that helps soothe your child's throat.

Creomulsion is intended to temporarily relieve cough caused by minor throat and bronchial irritation, which can occur with a cold. By addressing these symptoms, it aims to provide comfort and relief for your child during their illness.

Uses

If you're dealing with a cough caused by minor irritation in your throat or 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 day without the distraction of a persistent cough.

Dosage and Administration

When using this medication, it's important to follow the recommended dosage to ensure safety and effectiveness. You should not take more than 6 doses within a 24-hour period. To measure your dose accurately, use the enclosed dose cup.

For children aged 6 years to under 12 years, the recommended dose is 10 mL (which is equivalent to 2 teaspoons) every 4 hours. If your child is between 2 and under 6 years old, the dose is 5 mL (or 1 teaspoon) every 4 hours. However, if your child is under 2 years old, this medication should not be used. Always make sure to adhere to these guidelines for the best results.

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 used 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 before using this product if your cough is producing a lot of mucus or if you have a chronic cough due to conditions like smoking, asthma, chronic bronchitis, or emphysema.

Warnings and Precautions

You should not use this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of drug used for depression, psychiatric conditions, or Parkinson's disease. Additionally, you must wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your prescription contains an MAOI, please consult your doctor or pharmacist.

In the event of an overdose, it is crucial to seek medical help immediately or contact a Poison Control Center. You should also stop using this medication and call your doctor if your cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, as these may indicate a more serious health issue.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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 it comes to giving this medication to children, it's important to follow the recommended dosages based on their age. For children aged 6 years to under 12 years, you can give them 10 mL (which is about 2 teaspoons) every 4 hours. If your child is between 2 and under 6 years old, the dosage is 5 mL (or 1 teaspoon) every 4 hours.

However, please note that this medication should not be used for children under 2 years old. Always ensure you are measuring the doses accurately and consult with your healthcare provider if you have any questions or concerns about using this medication for your child.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available regarding its safety or effectiveness. This means that if you or a loved one is an older adult, it's especially important to consult with a healthcare provider before starting the medication. They can help assess any individual health needs and determine the best approach for treatment.

Always keep in mind that older adults may have different responses to medications due to factors like age-related changes in the body and existing health conditions. Your healthcare provider can guide you on the appropriate dosage and monitor for any potential side effects.

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, especially if you have any concerns about your kidney health.

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 you may have regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to be cautious about combining medications. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI), or if you have stopped taking one within the last two weeks, you should not use this medication. Mixing these drugs can lead to serious interactions that could affect your health.

Always discuss any medications you are taking with your healthcare provider. They can help you understand potential interactions and ensure that your treatment is safe and effective. Your health and safety should always come first, so don't hesitate to ask questions about your medications.

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 is packaged with a tamper-evident seal around the cap, which is an important safety feature that indicates whether the product has been opened or altered.

Additionally, rest assured that the product contains no alcohol, making it suitable for a variety of uses. Always handle the product with care, and if you have any questions about its use or storage, feel free to reach out for more information.

Additional Information

You should take this medication orally. For children aged 6 years to under 12 years, the recommended dose is 10 mL (which is equivalent to 2 teaspoons) every 4 hours. For children aged 2 to under 6 years, the dose is 5 mL (or 1 teaspoon) every 4 hours. Always follow the dosing instructions provided by your healthcare provider.

FAQ

What is Creomulsion For Children used for?

Creomulsion For Children is used to temporarily relieve cough due to minor throat and bronchial irritation, which may occur with a cold.

How does Creomulsion For Children work?

It contains the most effective cough suppressant available without a prescription, calming the urge to cough while its smooth consistency soothes the throat.

What is the recommended dosage for children?

For children 6 years to under 12 years, the dosage is 10 mL (2 tsp) every 4 hours. For children 2 to under 6 years, it is 5 mL (1 tsp) every 4 hours. Do not use for children under 2 years.

Are there any warnings associated with Creomulsion For Children?

Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor if cough lasts more than 7 days or is accompanied by fever, rash, or persistent headache.

What should I do in case of an overdose?

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

Can I use Creomulsion For Children if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

How should Creomulsion For Children be stored?

Store Creomulsion For Children at 20-25°C (68-77°F) and ensure the tamper evident seal around the cap is intact.

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 specified 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.

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. It is essential to utilize the enclosed dose cup for accurate measurement.

For children aged 6 years to under 12 years, the recommended dosage is 10 mL (2 teaspoons) administered every 4 hours as needed.

For children aged 2 years to under 6 years, the appropriate dosage is 5 mL (1 teaspoon) every 4 hours as needed.

This product is not recommended for use in children under 2 years of age.

Contraindications

There are no specified contraindications 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

The use of this product is contraindicated in patients currently taking prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric disorders, or Parkinson's disease. Additionally, it is advised to refrain from using this product for a minimum of two weeks following the discontinuation of an MAOI. Healthcare professionals should counsel patients to verify with their physician or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

In the event of an overdose, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay. Prompt action is essential to mitigate potential adverse effects.

Patients should discontinue use and consult a healthcare provider 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 a more serious underlying condition that requires further evaluation and intervention.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, particularly in patients who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this product is contraindicated in individuals taking MAOIs or within 2 weeks of stopping such medication. Patients are advised to consult a healthcare professional if they are uncertain whether their prescription includes an MAOI.

Common adverse reactions may include a cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms could indicate a serious underlying condition, and patients should discontinue use and seek medical advice if they experience these signs.

Additionally, patients should consult a doctor prior to use if they have a cough that is associated with excessive phlegm (mucus) or if they have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. These conditions may require further evaluation and management by a healthcare professional.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on MAOIs or for a period of two weeks following the discontinuation of MAOI therapy. The combination may result in serious interactions that could pose significant health risks. It is essential to ensure that the patient has completed the appropriate washout period before initiating treatment with this medication.

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 aged 6 years to under 12 years may be administered 10 mL (2 teaspoons) every 4 hours. For children aged 2 to under 6 years, the recommended dosage is 5 mL (1 teaspoon) every 4 hours. Use is not recommended in children under 2 years of age.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the variability in pharmacokinetics and pharmacodynamics that may occur with aging. Additionally, consideration should be given to the presence of comorbidities and the potential for polypharmacy in this population, which may necessitate dosage adjustments or increased monitoring.

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 drug 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 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. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Monitoring of vital signs and laboratory parameters may be warranted to assess the patient's condition and guide further management.

Healthcare professionals should also consider consulting a poison control center or relevant toxicology resources for additional guidance on managing potential overdosage scenarios.

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 use of the compound in question.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which include rash, pruritus, and urticaria.

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 with a tamper-evident seal around the cap to ensure safety and integrity. It should be stored at a controlled room temperature of 20-25°C (68-77°F). The formulation contains no alcohol, which may influence handling and storage considerations.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for pediatric patients. For children aged 6 years to under 12 years, the recommended dose is 10 mL (2 teaspoons) every 4 hours. For children aged 2 to under 6 years, the dosage is 5 mL (1 teaspoon) every 4 hours. 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 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.