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Childrens Multi-Symptom Cold

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Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
  • Phenylephrine Hydrochloride 2.5 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2014
Label revision date
December 3, 2025
Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
  • Phenylephrine Hydrochloride 2.5 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2014
Label revision date
December 3, 2025
Manufacturer
Wal-Mart Stores, Inc.
Registration number
M012
NDC root
49035-715

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Drug Overview

Equate™ Children's Multi-Symptom Cold is a medication designed to help relieve symptoms associated with the common cold in children aged 4 to 12 years. It contains three active ingredients: dextromethorphan HBr, which acts as a cough suppressant; guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions; and phenylephrine HCl, a nasal decongestant that alleviates stuffy noses.

This product works by temporarily relieving cough due to minor throat and bronchial irritation, reducing the intensity of coughing, and helping children sleep better. It also helps relieve nasal congestion and chest congestion, making it easier for children to breathe and feel more comfortable during a cold. The medication is alcohol-free and comes in a pleasant Very Berry flavor.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. This makes it easier for your body to drain the bronchial tubes and can lead to more productive coughs.

You may find this medication useful for temporarily relieving coughs caused by minor throat and bronchial irritation, which can happen with the common cold or from inhaling irritants. It can also help reduce the intensity of your cough and the urge to cough, making it easier for your child to fall asleep. Additionally, it can relieve nasal congestion and a stuffy nose associated with colds.

Dosage and Administration

It's important to follow the correct dosage when using this medication to ensure safety and effectiveness. You should never take more than 6 doses within a 24-hour period. To measure your dose accurately, use only the dosing cup that comes with the medication, and avoid using it with any other products to prevent confusion.

For children, the dosage varies by age. If your child is between 6 years and under 12 years, they should take 10 mL every 4 hours. For children aged 4 years to under 6 years, the dose is 5 mL every 4 hours. However, if your child is under 4 years old, this medication should not be used. Always consult with a doctor if you have any questions or concerns about the appropriate dosage for your child.

What to Avoid

It's important to be cautious when using this medication. You should not give it to a child who is currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain emotional conditions, or for two weeks after stopping an MAOI. If you're unsure whether your child's prescription includes an MAOI, please consult a doctor or pharmacist before administering this product.

Additionally, make sure to follow the dosage instructions carefully and do not exceed the recommended amount. Misusing or taking more than directed can lead to serious health issues, including dependence (a condition where the body becomes reliant on a substance). Always prioritize safety and seek guidance if you have any questions.

Side Effects

If your child experiences nervousness, dizziness, or trouble sleeping, it's important to stop using the medication and consult a doctor. Additionally, if symptoms do not improve within 7 days, or if a cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, these could indicate a more serious condition that requires medical attention.

Before using this medication, you should speak with a doctor if your child has a history of heart disease, high blood pressure, thyroid disease, diabetes, or a persistent cough, especially if it is associated with asthma or excessive mucus.

Warnings and Precautions

It's important to use this medication exactly as directed and not exceed the recommended dosage. If you notice that your child becomes nervous, dizzy, or has trouble sleeping, stop using the medication and consult your doctor. Additionally, if symptoms do not improve within 7 days, or if they occur alongside a fever, it's essential to seek medical advice.

In case of an overdose, please get emergency medical help or contact a Poison Control Center immediately. If your child's cough lasts more than 7 days, returns, or is accompanied by a fever, rash, or a persistent headache, stop using the medication and reach out to your doctor for further guidance.

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 is 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 planning to become pregnant, it’s important to know that the safety of this product during pregnancy has not been established. There may be potential risks to your fetus, and further studies are needed to fully understand these risks. Therefore, it is crucial to consult your doctor before using this product.

Currently, there are no specific dosage modifications recommended for pregnant individuals. Always seek guidance from a healthcare professional to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider about any concerns you may have regarding your health and breastfeeding.

Pediatric Use

You should avoid giving this medication to your child if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions. It's also important not to use it for at least two weeks after stopping an MAOI. If you're unsure whether your child's medication includes an MAOI, please consult with a doctor or pharmacist.

When administering this medication, follow these dosage guidelines: for children aged 6 to under 12 years, give 10 mL every 4 hours; for those aged 4 to under 6 years, give 5 mL every 4 hours. Do not use this medication for children under 4 years old. If your child experiences nervousness, dizziness, or sleeplessness, or if their symptoms do not improve within 7 days, you should stop use and consult a doctor. Additionally, if a cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, seek medical advice.

Geriatric Use

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

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is particularly true if you have reduced creatinine clearance (a measure of how well your kidneys are filtering waste). Regular monitoring of your renal function tests is essential to ensure your kidneys are working properly and to determine if any changes to your medication are necessary.

For those with significant renal impairment, special monitoring is required to keep track of your kidney health and adjust your treatment as needed. Always consult with your healthcare provider about the best approach for managing your medications in relation to your kidney function.

Hepatic Impairment

If you have liver problems, it's important to know that your condition can affect how your body processes certain medications. This means that the usual dosage may not be suitable for you, and adjustments might be necessary. If you have pre-existing liver conditions, your healthcare provider will likely monitor your liver function tests (which check how well your liver is working) regularly to ensure your safety.

When being prescribed medication, be sure to inform your doctor about your liver health. They may recommend a lower dose if you have moderate to severe liver impairment, and they will exercise caution in prescribing to you. Always follow your healthcare provider's guidance to manage your treatment safely.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

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). It's important not to refrigerate the product, as this can affect its effectiveness.

When using the product, a dosing cup is provided to help you measure the correct doses accurately. Always handle the product with care to maintain its quality and safety.

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 equate™ Children's Multi-Symptom Cold used for?

It helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and relieving nasal congestion.

What are the active ingredients in this medication?

The active ingredients are Dextromethorphan HBr (5 mg), Guaifenesin (100 mg), and Phenylephrine HCl (2.5 mg).

What age group is this medication indicated for?

It is indicated for children aged 4 to 12 years.

How should I dose this medication for my child?

For children 6 years to under 12 years, give 10 mL every 4 hours; for children 4 years to under 6 years, give 5 mL every 4 hours. Do not use in children under 4 years.

Are there any contraindications for using this medication?

Do not use it in a child taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do if my child experiences side effects?

Stop use and ask a doctor if your child gets nervous, dizzy, or sleepless, or if symptoms do not improve within 7 days.

Is this medication safe to use during pregnancy?

The safety of this product during pregnancy has not been established; consult a doctor if pregnant or planning to become pregnant.

How should I store this medication?

Store it between 15-30°C (59-86°F) and do not refrigerate.

What flavor does this medication come in?

It is available in Very Berry flavor.

What should I do in case of an overdose?

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

Packaging Info

Below are the non-prescription pack sizes of Childrens Multi-Symptom Cold (dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Multi-Symptom Cold.
Details

Drug Information (PDF)

This file contains official product information for Childrens Multi-Symptom Cold, 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 relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating drainage of the bronchial tubes and making coughs more productive.

Additionally, this drug temporarily relieves the intensity of coughing and the impulse to cough, aiding in the ability of children to sleep. It also alleviates nasal congestion and a stuffy nose associated with colds.

There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the following dosage guidelines. The maximum allowable dosage is 6 doses within a 24-hour period. It is imperative to measure the medication using only the dosing cup provided with the product, and this cup should not be used for any other products to ensure accurate dosing.

For children aged 6 years to under 12 years, the recommended dose is 10 mL every 4 hours as needed. For children aged 4 years to under 6 years, the appropriate dose is 5 mL every 4 hours as needed. It is important to note that this medication is not recommended for children under 4 years of age.

Healthcare professionals should ensure that caregivers understand these instructions to promote safe and effective use of the medication.

Contraindications

Use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a child's prescription, consultation with a healthcare professional is advised prior to administration of this product.

Additionally, the product should not be used in excess of the directed dosage.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this medication.

General precautions must be observed, including adherence to the recommended dosage. It is imperative that patients do not exceed the directed amount to avoid potential adverse effects.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers should instruct patients or caregivers to contact a Poison Control Center or seek emergency medical help without delay.

Patients should be advised to discontinue use and consult a physician under specific circumstances. If a child experiences symptoms such as nervousness, dizziness, or sleeplessness, it is essential to stop the medication and seek medical advice. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, a healthcare professional should be contacted. Furthermore, if a cough persists for more than 7 days, recurs, or is associated with fever, rash, or a persistent headache, patients should be instructed to stop taking the medication and consult their doctor.

Side Effects

Patients may experience a range of adverse reactions, although no specific side effects have been identified in clinical trials or postmarketing experiences. It is important for patients to monitor their symptoms and seek medical advice under certain circumstances.

Patients should stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days, or if they occur alongside fever, it is advisable to seek medical attention. A cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache may indicate a serious illness and warrants immediate medical evaluation.

Before using this product, patients with a history of heart disease, high blood pressure, thyroid disease, diabetes, or persistent or chronic cough (such as that associated with asthma) should consult a healthcare professional. Furthermore, individuals experiencing a cough that produces excessive phlegm (mucus) should also seek medical advice prior to use.

No additional adverse reactions have been reported.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Multi-Symptom Cold (dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Multi-Symptom Cold.
Details

Pediatric Use

Pediatric patients should not be administered this product if they are taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. Caregivers should consult a healthcare professional if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

For dosing, children aged 6 years to under 12 years may receive 10 mL every 4 hours, while those aged 4 years to under 6 years should receive 5 mL every 4 hours. This product is not recommended for children under 4 years of age.

Healthcare professionals should advise caregivers to discontinue use and consult a doctor if the child experiences nervousness, dizziness, or sleeplessness, if symptoms do not improve within 7 days, or if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache.

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

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use, as there may be potential risks to the fetus. Further studies are needed to determine the safety profile of this product in pregnant individuals. Currently, no specific dosage modifications are provided for pregnant individuals; therefore, it is essential to seek guidance from a healthcare professional regarding use during pregnancy.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in these patients, particularly those with significant kidney problems. For patients with reduced creatinine clearance, a reduced dose may be necessary to avoid potential adverse effects. Additionally, special monitoring is warranted for patients with significant renal impairment to ensure appropriate management of their treatment.

Hepatic Impairment

Hepatic impairment may affect the pharmacokinetics of the drug, necessitating dosage adjustments for patients with compromised liver function. It is essential to monitor liver function tests regularly in patients with pre-existing liver conditions to ensure safety and efficacy. Caution should be exercised when prescribing to patients with significant hepatic impairment, and a reduced dose should be considered for those with moderate to severe hepatic impairment. Regular assessment of liver function is recommended to guide treatment decisions and dosage modifications.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, symptomatic treatment, and, if applicable, the use of specific antidotes. It is crucial to consult local poison control guidelines and the product's prescribing information for detailed management protocols.

In all instances of suspected overdose, healthcare professionals should ensure that appropriate measures are taken to ensure patient safety and to mitigate any potential adverse effects.

Nonclinical Toxicology

There is no relevant information available regarding teratogenic or non-teratogenic effects. Additionally, no data has been provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: nervousness, dizziness, and sleeplessness. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that this product should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. If patients are uncertain whether their child's prescription includes an MAOI, they should be encouraged to consult with a doctor or pharmacist prior to administering this product.

Patients should be instructed to discontinue use and consult a healthcare professional if their child experiences symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be informed to stop use and seek medical advice if symptoms do not improve within seven days or if they are accompanied by fever. It is also important to advise patients to stop use and contact a doctor if a cough persists for more than seven days, recurs, or occurs with fever, rash, or a persistent headache, as these may indicate a serious illness.

While using this product, patients must be reminded not to exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before use if their child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or a persistent or chronic cough, such as that associated with asthma. Furthermore, patients should be advised to seek medical guidance if their child has a cough that produces excessive phlegm (mucus).

Storage and Handling

The product is supplied in a configuration that includes a dosing cup for accurate measurement of doses. It should be stored at a temperature range of 15-30°C (59-86°F). It is important to note that refrigeration is not permitted for this product. Proper adherence to these storage conditions is essential 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 Childrens Multi-Symptom Cold, 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 Childrens Multi-Symptom Cold, 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.