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Signature Care

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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 2026
Label revision date
February 11, 2026
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 2026
Label revision date
February 11, 2026
Manufacturer
SAFEWAY
Registration number
M012
NDC root
21130-162
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 is a medication designed for children aged 4 and older, available in a pleasant berry flavor. It combines 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 relieves stuffy noses.

This product temporarily alleviates symptoms associated with the common cold, including cough due to throat and bronchial irritation, nasal congestion, and chest congestion. By breaking up mucus and controlling coughing, it helps your child breathe easier and get a better night's sleep.

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 use this medication to temporarily relieve cough caused by minor throat and bronchial irritation, which can happen with the common cold or from inhaling irritants. It also helps reduce the intensity of your cough and the urge to cough, making it easier for your child to sleep. Additionally, it can relieve nasal congestion and a stuffy nose associated with colds.

Dosage and Administration

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

You should avoid using this product 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 product for at least 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 administering this product.

It's also important to follow the dosing instructions carefully and not exceed the recommended amount. Taking more than directed can lead to unwanted effects, so always use this product as advised.

Side Effects

You should stop using this medication and consult a doctor if you experience nervousness, dizziness, or sleeplessness. Additionally, if your symptoms do not improve within 7 days, or if you develop a cough that lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, these could indicate a more serious condition.

Before using this medication for a child, it's important to check with a doctor if the child has any of the following: heart disease, high blood pressure, thyroid disease, diabetes, a cough with excessive mucus, or a chronic cough like that seen in asthma. Also, do not use this medication in children who are taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping such a medication, as this could lead to serious interactions. If you're unsure whether the child's prescription includes an MAOI, please consult a doctor or pharmacist.

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) for depression, psychiatric conditions, or Parkinson's disease, or for two weeks after stopping such medication. If you're unsure whether your child's prescription includes an MAOI, please consult a doctor or pharmacist.

Before using this medication, check with a doctor if your child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, a cough with excessive mucus, or a chronic cough like asthma. If your child experiences nervousness, dizziness, or sleeplessness, or if symptoms do not improve within seven days or are accompanied by fever, it's important to stop using the medication and contact a doctor. Additionally, if a cough lasts more than seven days, returns, or occurs with fever, rash, or a persistent headache, seek medical advice as these may indicate a more serious issue. In case of an overdose, get emergency help immediately or contact a Poison Control Center at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help. Your safety is the top priority.

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, but specific studies or data are not available to clarify these risks. Therefore, it is crucial to consult your doctor before using this product.

While there are no specific dosage modifications mentioned for pregnant individuals, discussing your options with a healthcare provider is strongly advised. This will help ensure that you make informed decisions about your health and the health of your baby.

Lactation Use

If you are breastfeeding, it's important to talk to your healthcare professional before using this product. There is a possibility that it can be passed into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Therefore, exercising caution is recommended to ensure the safety and well-being of both you and your baby.

Pediatric Use

It's important to be cautious when giving this medication to children. Do 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 the product, consult your doctor if your child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, a cough with excessive mucus, or a chronic cough like asthma.

When administering this medication, ensure you do not exceed the recommended dosage. For children aged 6 to under 12 years, the dose is 10 mL every 4 hours, while for those aged 4 to under 6 years, it is 5 mL every 4 hours. Children under 4 years should not use this medication at all. Always use the dosing cup provided and keep the medication out of reach of children. If your child experiences nervousness, dizziness, sleeplessness, or if symptoms do not improve within 7 days, contact a doctor. In case of overdose, seek medical help immediately or call the Poison Control Center at 1-800-222-1222.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to discuss any new prescriptions with your healthcare provider. They can help ensure that the medication is safe and appropriate for you or your loved one, considering any existing health conditions or medications.

If you have concerns about how this medication might affect you or an older adult in your care, please consult with a healthcare professional for personalized advice.

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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. Doing so can lead to serious interactions, and it’s also important to wait at least two weeks after stopping the MAOI before starting this medication.

Always discuss any medications or tests with your healthcare provider. They can help ensure that you avoid potential risks and that your treatment plan is safe and effective. Your health and safety should always come first, so don’t hesitate to ask questions or express any concerns you may have.

Storage and Handling

To ensure the best use of your product, store it at room temperature. It's important not to refrigerate it, as this can affect its effectiveness. When you're ready to use the product, a dosing cup is provided to help you measure the correct amount safely and accurately.

Always handle the product with clean hands and ensure that the dosing cup is also clean before use. Following these simple guidelines 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 Multi-Symptom Cold used for?

Children's Multi-Symptom Cold helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive. It temporarily relieves cough, nasal congestion, and stuffy nose due to colds.

What are the active ingredients in Children's Multi-Symptom Cold?

The active ingredients include Dextromethorphan HBr (5 mg) as a cough suppressant, Guaifenesin (100 mg) as an expectorant, and Phenylephrine HCl (2.5 mg) as a nasal decongestant.

What is the recommended dosage for children?

For children 6 years to under 12 years, the dosage is 10 mL every 4 hours. For children 4 years 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, sleeplessness, or if symptoms do not improve within 7 days.

Is it safe to use Children's Multi-Symptom Cold during pregnancy?

The safety of this product during pregnancy has not been established. Consult a healthcare provider before use if pregnant or planning to become pregnant.

Can nursing mothers use this product?

Nursing mothers should consult a healthcare professional before using this product, as there is potential for excretion in breast milk.

How should I store Children's Multi-Symptom Cold?

Store at room temperature and do not refrigerate. Keep out of reach of children.

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Packaging Info

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

Packaging configurations for Signature Care.
Details

Drug Information (PDF)

This file contains official product information for Signature Care, 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 assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

Additionally, this drug temporarily relieves the intensity of coughing and the impulse to cough, which may help children achieve restful 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

The maximum recommended dosage is 6 doses within a 24-hour period. It is essential to measure the dosage 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. The product is not recommended for use in children under 4 years of age.

Healthcare professionals should advise caregivers to adhere strictly to these dosing guidelines or any specific instructions provided by a physician.

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, and Parkinson's disease. Prior to administration, consult a healthcare professional if there is uncertainty regarding the presence of an MAOI in the child's prescription regimen. Additionally, it is essential to adhere to the recommended dosage and not exceed the directed amount while using this product.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions when considering the use of this product in pediatric patients.

Warnings This product must not be administered to children who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for a period of two weeks following the cessation of an MAOI. If there is uncertainty regarding whether a child's prescription includes an MAOI, it is essential to consult a healthcare professional, such as a doctor or pharmacist, prior to administration.

General Precautions Prior to use, it is advisable to consult a healthcare provider if the child has any of the following conditions:

  • Heart disease

  • High blood pressure

  • Thyroid disease

  • Diabetes

  • A cough that produces excessive phlegm (mucus)

  • A persistent or chronic cough, such as that associated with asthma

Emergency Medical Help Instructions In the event of an overdose, immediate medical assistance should be sought. Contact a Poison Control Center without delay at 1-800-222-1222.

Stop Taking and Call Your Doctor Instructions The use of this product should be discontinued and a healthcare provider should be contacted if any of the following occur:

  • Nervousness, dizziness, or sleeplessness

  • Symptoms do not improve within 7 days or are accompanied by fever

  • A cough persists for more than 7 days, recurs, or is associated with fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Side Effects

Patients may experience a range of adverse reactions while using this product. It is important to monitor for serious symptoms and seek medical advice if they occur. 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 if they are accompanied by fever, it is advised to seek medical attention. A cough that persists for more than 7 days, recurs, or occurs with fever, rash, or a persistent headache may indicate a serious underlying condition and warrants immediate medical evaluation.

Before using this product, it is crucial for caregivers to consult a healthcare provider if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or a cough that produces excessive phlegm. Special caution is also advised for children with a persistent or chronic cough, such as that associated with asthma.

Warnings are in place regarding the use of this product in children who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. The product should not be administered to such children or within 2 weeks of stopping the MAOI. If there is uncertainty regarding the presence of an MAOI in the child's prescription medication, it is essential to consult a doctor or pharmacist prior to use.

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 specific dosage adjustments or monitoring recommendations are necessary beyond the aforementioned contraindication.

Packaging & NDC

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

Packaging configurations for Signature Care.
Details

Pediatric Use

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

When administering this product, it is crucial to adhere to the recommended dosage and not exceed 6 doses within a 24-hour period. The dosing should be measured using the provided dosing cup, which should not be used with other products. The recommended dosages are as follows: for children aged 6 years to under 12 years, 10 mL every 4 hours; for children aged 4 years to under 6 years, 5 mL every 4 hours; and this product is not recommended for children under 4 years of age.

Parents and caregivers should monitor for any adverse effects, including nervousness, dizziness, or sleeplessness, and should discontinue use and consult a healthcare professional if symptoms do not improve within 7 days, if the cough persists for more than 7 days, or if it is accompanied by fever, rash, or a persistent headache. It is important to keep this product out of reach of children, and in the event of an overdose, medical assistance should be sought immediately or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 provider prior to use, as there may be potential risks to the fetus; however, specific studies or data regarding these risks are not provided in the prescribing information. No specific dosage modifications for pregnant individuals are mentioned. It is strongly advised that women of childbearing potential discuss the use of this product with their healthcare provider to ensure informed decision-making regarding potential fetal outcomes.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

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 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center without delay. The national helpline for poison control can be reached at 1-800-222-1222.

Prompt intervention is crucial in managing overdose situations to mitigate potential adverse effects. It is essential for healthcare providers to assess the patient's condition and initiate appropriate treatment protocols based on the specific circumstances of the overdose.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 2 weeks of stopping such medication. Patients should be encouraged to consult with a doctor or pharmacist if they are uncertain whether their child's prescription includes an MAOI.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if symptoms do not improve within 7 days, or if they occur alongside fever. Patients should also be aware that a cough lasting more than 7 days, recurring cough, or cough accompanied by fever, rash, or persistent headache may indicate a serious condition and warrants medical evaluation.

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

Storage and Handling

The product is supplied with a dosing cup included for accurate measurement. It should be stored at room temperature, ensuring that it is not refrigerated to maintain its efficacy. Proper handling is essential to preserve the integrity 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 Signature Care, 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 Signature Care, 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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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.