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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
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 2018
Label revision date
December 22, 2025
Drug Information (PDF)
Prescribing information, PDF file
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
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 2018
Label revision date
December 22, 2025
Manufacturer
CVS PHARMACY
Registration number
M012
NDC root
69842-570
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 DAYTIME MULTI-SYMPTOM COLD is an oral solution designed to help relieve symptoms associated with the common cold in children aged 4 to 11 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 nose and nasal congestion.

This medication temporarily relieves cough due to minor throat and bronchial irritation, reduces the intensity of coughing, and helps children sleep better by minimizing the impulse to cough. Additionally, it effectively breaks up mucus and relieves chest congestion, making it easier for your child to breathe comfortably.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. This action helps clear out bothersome mucus from your airways, making your coughs more productive.

You can also use this medication to temporarily relieve symptoms such as a cough caused by minor throat and bronchial irritation, which can happen with the common cold or from inhaling irritants. It can help with a stuffy nose and nasal congestion due to a cold, reduce the intensity of your cough, and even lessen the urge to cough, making it easier for your child to sleep.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure safety and effectiveness. You should never take more than the directed amount, and make sure not to exceed 6 doses within a 24-hour period. Always use the dose cup that comes with the medication for accurate measurement.

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

What to Avoid

You should avoid using this medication in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, psychiatric conditions, or Parkinson's disease. Additionally, do not use this medication for at least 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.

It's also important to follow the recommended dosage carefully and not exceed it. Misusing or abusing this medication 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 or concerns.

Side Effects

If you experience nervousness, dizziness, or trouble sleeping while using this medication, it's important to stop using it and consult your doctor. Additionally, if your symptoms do not improve within 7 days, or if they occur alongside a fever, you should seek medical advice. A cough that lasts more than 7 days, keeps coming back, or is accompanied by a fever, rash, or a persistent headache may indicate a more serious condition, and you should contact your healthcare provider.

Warnings and Precautions

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

Before using this product, check with a doctor if your child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, a chronic cough (like asthma), or a cough with excessive mucus. If your child experiences nervousness, dizziness, or sleeplessness, or if symptoms do not improve within seven days, you should stop using the medication and contact a doctor. Additionally, if a cough lasts more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, seek medical advice as these may indicate a more serious issue. In case of an overdose, get emergency medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than typical side effects.

Always err on the side of caution—if you think you or someone else may have taken too much of a medication, don’t wait for symptoms to appear. Getting prompt assistance can be vital for safety and recovery.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this medication during pregnancy has not been established. You should consult your doctor before using it, as there may be potential risks to your fetus that are not clearly defined. Caution is advised, and you should only use this medication if it is clearly needed and after discussing it with your healthcare provider.

There are no specific dosage modifications provided for pregnant individuals, but it's essential to prioritize your health and the health of your baby by seeking professional guidance.

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

It's important to be cautious when giving this medication to children. You should not use it if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has stopped taking one within the last two weeks. Before using this medication, consult your doctor if your child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, a persistent cough (like asthma), or a cough with excessive mucus.

For dosing, children aged 6 to under 12 can take 10 mL every 4 hours, while those aged 4 to under 6 should take 5 mL every 4 hours. This medication is not recommended for children under 4 years old. Always keep the medication out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to remember that each person is unique. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate for individual health needs.

Since there are no specific dosage adjustments or safety concerns mentioned for elderly patients, you should still monitor for any unusual side effects or changes in health. Regular check-ins with a healthcare professional can help manage any potential issues that may arise.

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 may affect you 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 kidney health. They can help monitor your condition and make any necessary adjustments to 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 (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to be cautious when it comes to medications, especially if you or your child are taking certain drugs. For instance, if your child is on a prescription monoamine oxidase inhibitor (MAOI), a type of medication used to treat depression, you should avoid using this drug while they are taking the MAOI and for at least two weeks after stopping it. This is crucial because combining these medications can lead to serious interactions that may affect your child's health.

Always discuss any medications or treatments with your healthcare provider. They can help ensure that you avoid potential risks and manage your health safely.

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) occasionally. Always check the end flap of the packaging for the expiration date and lot number, as this information is important for safety and effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Proper storage and careful handling will help you use the product safely and effectively.

Additional Information

You should 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 Children's DAYTIME MULTI-SYMPTOM COLD used for?

Children's DAYTIME MULTI-SYMPTOM COLD helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive. It temporarily relieves cough, stuffy nose, and nasal congestion due to a cold.

What are the active ingredients in this medication?

The active ingredients are Dextromethorphan HBr (cough suppressant), Guaifenesin (expectorant), and Phenylephrine HCl (nasal decongestant).

What is the recommended dosage for children?

For children 6 to under 12 years, the dosage is 10 mL every 4 hours. For children 4 to under 6 years, it is 5 mL every 4 hours. Do not use in children under 4 years.

Are there any contraindications for using this product?

Do not use this product in children taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor if unsure.

What should I do if my child experiences side effects?

Stop use and ask a doctor if your child experiences nervousness, dizziness, or sleeplessness, or if symptoms do not improve within 7 days.

Is this medication safe for pregnant or nursing mothers?

Safety during pregnancy has not been established, and there are no specific warnings for nursing mothers. Consult a healthcare provider before use.

How should this medication be stored?

Store at 25°C (77°F), with permitted excursions between 15°-30°C (59°-86°F). Check the end flap for the expiration date and lot number.

What flavor does this medication come in?

Children's DAYTIME MULTI-SYMPTOM COLD comes in a 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.

Is there a money-back guarantee?

Yes, there is a 100% money-back guarantee.

Packaging Info

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

Packaging configurations for Cold.
Details

Drug Information (PDF)

This file contains official product information for 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 aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the expulsion of bothersome mucus and enhancing the productivity of coughs.

Additionally, this drug provides temporary relief from nasal congestion and stuffy nose associated with colds, as well as reducing the intensity of coughing and the impulse to cough, which may assist children in achieving restful sleep.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. It is imperative not to exceed the directed dosage. The maximum allowable dosage is 6 doses within a 24-hour period.

The provided dose cup must be utilized for accurate measurement. The dosing recommendations are as follows:

For children aged 6 to under 12 years, the recommended dose is 10 mL administered every 4 hours. For children aged 4 to under 6 years, the appropriate dose is 5 mL every 4 hours. It is important to note that this product is not indicated for use in children under 4 years of age.

Healthcare professionals should ensure that caregivers are informed of these guidelines 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 commonly 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, exceeding the recommended dosage is contraindicated.

Warnings and Precautions

The use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. Healthcare professionals should advise caregivers to consult a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

Before administering this product, it is essential to consult a healthcare provider if the child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, a persistent or chronic cough (such as that associated with asthma), or a cough accompanied by excessive phlegm (mucus). These conditions may necessitate additional monitoring or alternative treatment strategies.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Caregivers should be instructed to discontinue use and consult a healthcare professional if the child experiences nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days, or if they are accompanied by fever, further evaluation is warranted. A cough that persists for more than seven days, recurs, or is associated with fever, rash, or a persistent headache may indicate a serious underlying condition and requires prompt medical attention.

Side Effects

Patients should discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, medical advice should be sought. A persistent cough lasting more than 7 days, especially if it recurs or is associated with fever, rash, or a persistent headache, may indicate a serious underlying condition and warrants immediate medical evaluation.

Drug Interactions

The use of this medication is contraindicated in pediatric patients who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing 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 this medication. Therefore, no further dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

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

Packaging configurations for Cold.
Details

Pediatric Use

Pediatric patients should not use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. Prior to administration, it is essential to consult a healthcare professional if the child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, persistent or chronic cough (such as that associated with asthma), or cough accompanied by excessive phlegm.

Dosing recommendations for pediatric patients are as follows: for children aged 6 to under 12 years, the recommended dose is 10 mL every 4 hours; for children aged 4 to under 6 years, the dose is 5 mL every 4 hours. This medication is not recommended for children under 4 years of age.

It is crucial to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any recommendations or considerations for this population. There are no indicated dosage adjustments, safety concerns, or special precautions outlined for geriatric patients.

Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering the absence of data specific to this demographic. Monitoring for efficacy and safety may be warranted, given the general considerations for medication use in older adults.

Pregnancy

Safety during pregnancy has not been established for this medication. Pregnant patients or those planning to become pregnant should consult a healthcare provider prior to use. While potential risks to the fetus are not clearly defined, caution is advised when considering treatment. There are no specific dosage modifications recommended for pregnant individuals. It is essential to use this medication only if clearly needed and after thorough discussion with a healthcare provider regarding the 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 patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective care.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, and sleeplessness. It is noted that these reactions may occur in children using the product.

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 a doctor or pharmacist prior to administering this product.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be informed that if symptoms do not improve within seven days, or if they occur alongside a fever, medical advice should be sought. Persistent cough lasting more than seven days, recurrent cough, or cough accompanied by fever, rash, or a persistent headache may indicate a serious condition, warranting further evaluation.

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

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15° to 30°C (59° 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

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 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 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.

Learn more in our Editorial Policy

Last AI update:

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.