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Multi-Symptom Cold and Fever

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Active ingredients
  • Acetaminophen 325 mg/10 mL
  • Guaifenesin 200 mg/10 mL
  • Dextromethorphan Hydrobromide 10 mg/10 mL
  • Phenylephrine Hydrochloride 5 mg/10 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
February 25, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 325 mg/10 mL
  • Guaifenesin 200 mg/10 mL
  • Dextromethorphan Hydrobromide 10 mg/10 mL
  • Phenylephrine Hydrochloride 5 mg/10 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Solution
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 2021
Label revision date
February 25, 2026
Manufacturer
CVS PHARMACY
Registration number
M012
NDC root
69842-475
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

Children's Multi-Symptom Cold & Fever Oral Solution is a medication designed to help relieve various symptoms associated with the common cold and flu in children aged 6 to 11 years. It contains several active ingredients: acetaminophen, which acts as a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; guaifenesin, an expectorant that helps loosen mucus and make coughs more productive; and phenylephrine HCl, a nasal decongestant.

This solution temporarily alleviates symptoms such as minor aches and pains, sore throat, headache, stuffy nose, nasal congestion, and coughing due to throat and bronchial irritation. It also helps reduce fever, making it easier for your child to feel comfortable and get the rest they need.

Uses

You can use this medication to temporarily relieve various symptoms associated with the common cold and flu. It helps ease minor aches and pains, sore throat, headaches, and nasal congestion. If you're dealing with a stuffy nose or a cough due to minor throat and bronchial irritation, this medication can also help reduce the intensity of your cough and make it easier for your child to sleep.

Additionally, it can temporarily lower fever and assist in loosening phlegm (mucus) and thinning bronchial secretions. This action helps clear out bothersome mucus from your bronchial passageways, making your coughs more productive.

Dosage and Administration

It's important to follow the dosage instructions carefully when using this medication. You should never take more than the directed amount. For children aged 6 to under 12 years, the recommended dose is 10 mL, which you should measure using the dosing cup provided. If your child is under 6 years old, do not use this product.

You can repeat the dose every 4 hours as long as symptoms persist, but remember not to exceed 5 doses in a 24-hour period. Always use the dosing cup that comes with the medication to ensure accurate measurement. If you have any questions or need further guidance, consult your doctor.

What to Avoid

You should avoid using this product alongside any other medications that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication includes acetaminophen, please consult with a doctor or pharmacist. Additionally, do not give this product to a child who is currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson’s disease, or for at least two weeks after stopping an MAOI. Again, if you’re uncertain about your child’s medication, it’s best to ask a healthcare professional.

While using this product, it’s crucial that you do not exceed the recommended dosage. This helps prevent potential misuse or dependence (a condition where the body becomes reliant on a substance). Always prioritize safety and consult with a healthcare provider if you have any questions or concerns.

Side Effects

You should be aware of some important warnings and potential side effects when using this product. It contains acetaminophen, which can lead to severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. Additionally, there is a risk of serious skin reactions, such as redness, blisters, or rashes. If any of these skin symptoms occur, stop using the product and seek medical help immediately.

It's also important to consult a doctor if your child experiences severe sore throat that lasts more than 2 days, or if it is accompanied by fever, headache, rash, nausea, or vomiting. You should stop use and contact a doctor if your child feels nervous, dizzy, or has trouble sleeping, if pain or cough worsens or lasts more than 5 days, or if new symptoms develop. Always check with a doctor before use if your child has liver disease, high blood pressure, heart disease, thyroid disease, diabetes, or a chronic cough. If your child is taking the blood thinner warfarin, consult a doctor or pharmacist before use.

Warnings and Precautions

It's important to be aware of some key warnings and precautions when using this product, which contains acetaminophen. Taking more than 5 doses in 24 hours can lead to severe liver damage, especially if combined with other medications that also contain acetaminophen. Additionally, be cautious of potential severe skin reactions, which may include symptoms like skin reddening, blisters, or rash. If you notice any of these skin reactions, stop using the product and seek medical help immediately. If your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor right away.

Before using this product, it's wise to check with a doctor if your child has any existing health conditions, such as liver disease, high blood pressure, heart disease, thyroid disease, diabetes, or a chronic cough. If your child is taking the blood thinner warfarin, consult a doctor or pharmacist before use. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately, even if no symptoms are present, as prompt attention is crucial.

You should also stop using the product and call your doctor if your child experiences nervousness, dizziness, or sleeplessness, if pain or cough worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, or if new symptoms develop. These could indicate a more serious condition that requires medical attention.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. Always err on the side of caution and get help right away if you think an overdose has occurred. Your quick action can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult your doctor before using this product, as its safety during pregnancy has not been established. While specific risks to the fetus are not detailed, caution is advised. There are no specific dosage adjustments provided for pregnant individuals, but discussing your options with a healthcare provider is strongly recommended to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If you are considering this medication for your child, it's important to follow specific guidelines. For children aged 6 to under 12 years, the recommended dose is 10 mL, using the dosing cup provided. However, do not use this medication for children under 6 years old. Be cautious, as giving more than 5 doses in a 24-hour period can lead to severe liver damage.

Before giving this medication, consult your doctor if your child has any of the following conditions: liver disease, high blood pressure, heart disease, thyroid disease, diabetes, or a persistent cough, especially if it’s related to asthma or involves a lot of mucus. Additionally, if your child is taking the blood thinner warfarin or has recently stopped taking a monoamine oxidase inhibitor (MAOI), you should also speak with a healthcare professional. Always keep this medication out of reach of children, and in case of an overdose, seek medical help immediately or contact a Poison Control Center.

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, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have 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 health situation. They can help determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If your child has liver problems, it's important to be cautious with medications that contain acetaminophen. Taking more than 5 doses in a 24-hour period can lead to severe liver damage, which is the maximum daily amount recommended. Additionally, you should always consult a doctor before giving this medication if your child has liver disease, as they can provide guidance tailored to your child's specific health needs.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if your child is taking warfarin, a blood-thinning drug. This is to ensure that there are no potential interactions that could affect your child's health.

While there are no specific drug interactions or laboratory test interactions noted, discussing all medications and tests with your healthcare provider is always a good practice. This helps ensure safe and effective treatment tailored to your child's needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, specifically at 25°C (77°F). It’s acceptable for the temperature to vary between 15°C and 30°C (59°F to 86°F), but try to keep it as close to the recommended temperature as possible.

Always check the end flap of the packaging for the expiration date and lot number, as this information is crucial for safety and effectiveness. Proper handling and storage will help maintain the quality of the product, so please follow these guidelines closely.

Additional Information

If you are taking this medication, it is important to know that it is administered orally and you should repeat the dose every 4 hours as long as your symptoms persist.

Additionally, if you are concerned about the potential for medicine abuse, especially among teens, you can find helpful resources at www.StopMedicineAbuse.org.

FAQ

What is the main use of this product?

This product temporarily relieves common cold and flu symptoms, including minor aches and pains, sore throat, headache, stuffy nose, and cough.

What age group is this product suitable for?

This product is indicated for children aged 6 to 11 years.

How should I dose this medication for my child?

For children aged 6 to under 12 years, the recommended dose is 10 mL using the dosing cup provided, not to exceed 5 doses in 24 hours.

What should I do if my child has a severe sore throat?

If your child's sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Are there any warnings associated with this product?

Yes, this product contains acetaminophen, which can cause severe liver damage if more than 5 doses are taken in 24 hours or if taken with other acetaminophen-containing drugs.

Can this product be used during pregnancy?

Safety during pregnancy has not been established, so it is recommended to consult a healthcare provider before use.

What should I do in case of an overdose?

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

Is there any alcohol in this product?

No, this product does not contain added alcohol.

What are the active ingredients in this medication?

The active ingredients are Acetaminophen (pain reliever, fever reducer), Dextromethorphan HBr (cough suppressant), Guaifenesin (expectorant), and Phenylephrine HCl (nasal decongestant).

What should I do if my child is taking other medications?

Ask a doctor or pharmacist before use if your child is taking other medications, especially blood thinners like warfarin.

Packaging Info

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

Packaging configurations for Multi-Symptom Cold and Fever.
Details

Drug Information (PDF)

This file contains official product information for Multi-Symptom Cold and Fever, 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 symptoms associated with the common cold and flu, including minor aches and pains, sore throat, headache, stuffy nose, intensity of coughing, nasal congestion, cough due to minor throat and bronchial irritation, and the impulse to cough that may interfere with sleep in children.

Additionally, this drug temporarily reduces fever and assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage and administration guidelines. The product is intended for use as directed, and it is crucial not to exceed the maximum dosage.

For children aged 6 to under 12 years, the recommended dose is 10 mL, administered using the dosing cup provided. This dose may be repeated every 4 hours as needed while symptoms persist, but it is important not to exceed 5 doses within a 24-hour period.

This product is not suitable for children under 6 years of age. Additionally, healthcare professionals should note that the product does not include comprehensive directions or warnings for adult use.

Contraindications

Use of this product is contraindicated in the following situations:

  • Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

  • In pediatric patients who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Verification of the presence of an MAOI in the child's medication should be conducted with a healthcare professional prior to administration of this product.

Additionally, it is essential to adhere to the recommended dosage to avoid potential adverse effects.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise that no more than 5 doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen.

Severe skin reactions have been associated with acetaminophen use. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists beyond 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is essential.

Healthcare professionals should inquire about the child’s medical history prior to recommending this product, particularly if the child has any of the following conditions: liver disease, high blood pressure, heart disease, thyroid disease, diabetes, or a persistent or chronic cough, such as that associated with asthma. Additionally, caution is advised if the child is experiencing a cough that produces excessive phlegm (mucus). It is also important to consult a doctor or pharmacist if the child is currently taking warfarin, a blood-thinning medication.

In the event of an overdose, immediate medical attention is critical. Healthcare providers should instruct caregivers to contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should be advised to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Furthermore, if pain, nasal congestion, or cough worsens or persists beyond 5 days, or if fever worsens or lasts more than 3 days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a recurrence of cough accompanied by rash or headache that lasts should also prompt immediate medical evaluation, as these may indicate a serious underlying condition.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded or if it is taken concurrently with other medications containing acetaminophen.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients should discontinue use immediately and seek medical assistance.

Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

Common adverse reactions that warrant discontinuation of use and consultation with a doctor include nervousness, dizziness, or sleeplessness. Patients should also seek medical advice if pain, nasal congestion, or cough worsens or lasts longer than 5 days, if fever worsens or lasts more than 3 days, or if redness or swelling is observed. The emergence of new symptoms or a cough that recurs or is accompanied by a rash or headache lasting longer than expected may indicate a serious condition requiring medical evaluation.

Before using this product, it is advisable for patients to consult a healthcare provider if they have a history of liver disease, high blood pressure, heart disease, thyroid disease, diabetes, or a persistent or chronic cough, such as that associated with asthma. Furthermore, patients should seek guidance from a doctor or pharmacist if they are currently taking the blood-thinning medication warfarin.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. This precaution is essential to ensure safe and effective use, as potential interactions may affect anticoagulation control.

Currently, there are no additional drug interactions or laboratory test interactions reported for this medication. Therefore, no specific dosage adjustments or monitoring recommendations are available beyond the aforementioned consideration regarding warfarin.

Packaging & NDC

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

Packaging configurations for Multi-Symptom Cold and Fever.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 10 mL using the dosing cup provided. The use of this medication is not recommended for children under 6 years of age.

Healthcare professionals should be aware of the potential for severe liver damage if a child exceeds 5 doses within a 24-hour period, which is the maximum daily amount. Caution is advised in pediatric patients who are taking a prescription monoamine oxidase inhibitor (MAOI) or have discontinued MAOI therapy within the past 2 weeks.

Prior to administration, it is essential to consult a healthcare provider if the child has any of the following conditions: liver disease, high blood pressure, heart disease, thyroid disease, diabetes, or a persistent or chronic cough, particularly if associated with asthma or excessive mucus. Additionally, consultation with a doctor or pharmacist is recommended if the child is concurrently taking the anticoagulant warfarin.

This medication should be kept out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

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

Safety during pregnancy has not been established for this product. Pregnant patients or those planning to become pregnant are advised to consult a healthcare provider prior to use. While specific potential risks to the fetus are not detailed, caution is recommended. There are no specific dosage modifications for pregnant individuals provided in the prescribing information. It is essential for women of childbearing potential to discuss the use of this product with their healthcare provider to ensure informed decision-making regarding potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals 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 should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if the maximum daily amount of more than 5 doses in 24 hours is exceeded, or if the patient is concurrently taking other medications that contain acetaminophen.

Before administration, it is advised to consult a healthcare professional if the patient has a history of liver disease. This precaution is essential to ensure the safety and efficacy of the treatment in individuals with compromised liver function.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, it is essential to monitor the patient closely and provide appropriate care based on clinical judgment and established protocols.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

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 essential to emphasize that prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed not to exceed the recommended dosage of the medication. It is important for healthcare providers to encourage patients to consult with a doctor before use if the child has any of the following conditions: liver disease, high blood pressure, heart disease, thyroid disease, diabetes, persistent or chronic cough (such as that associated with asthma), or a cough accompanied by excessive phlegm (mucus).

Additionally, healthcare providers should recommend that patients ask a doctor or pharmacist before use if the child is currently taking the blood-thinning medication warfarin. This precaution is vital to ensure the safe and effective use of the medication.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product safety.

Additional Clinical Information

Clinicians should be aware that the medication is administered orally, with a recommended repeat dose every 4 hours as long as symptoms persist.

For concerns regarding substance abuse, particularly among adolescents, resources are available at www.StopMedicineAbuse.org to educate on the risks associated with medicine misuse. No further information is provided regarding laboratory tests, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Multi-Symptom Cold and Fever, 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 Multi-Symptom Cold and Fever, 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.