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Signature Care Childrens 12 Hour Cough Relief

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Active ingredient
Dextromethorphan Hydrobromide 30 mg/5 mL
Other brand names
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
September 8, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dextromethorphan Hydrobromide 30 mg/5 mL
Other brand names
Dosage form
Suspension
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 2022
Label revision date
September 8, 2025
Manufacturer
Sixarp, LLC
Registration number
ANDA091135
NDC root
59368-246
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

DExtromethorphan Polistirex is a cough suppressant designed to provide relief from coughing due to minor throat and bronchial irritation, which can occur with the common cold or from inhaled irritants. This extended-release oral suspension comes in a grape-flavored liquid form and is suitable for children aged 4 and older, making it a convenient option for both kids and adults.

By temporarily relieving the impulse to cough, Dextromethorphan Polistirex can help you get a better night's sleep or simply feel more comfortable during the day. It is alcohol-free and includes a dosing cup for easy measurement.

Uses

If you're dealing with a cough caused by minor throat and bronchial irritation, such as what you might experience with a common cold or from inhaling irritants, this medication can help. It works by temporarily relieving your cough, making it easier for you to go about your day.

Additionally, if you're struggling to sleep because of a persistent cough, this medication can also help reduce the urge to cough, allowing you to rest more comfortably.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. It's important to measure your dose using only the dosing cup that comes with the product, as using it with other products can lead to incorrect dosing.

For adults and children aged 12 and older, the recommended dose is 10 mL every 12 hours, but you should not take more than 20 mL in a 24-hour period. If your child is between 6 and 12 years old, they should take 5 mL every 12 hours, with a maximum of 10 mL in a day. For children aged 4 to under 6 years, the dose is 2.5 mL every 12 hours, not exceeding 5 mL in 24 hours. Please do not use this medication for children under 4 years of age. Always follow your doctor’s instructions if they provide different guidance.

What to Avoid

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

Be aware that this product contains sodium metabisulfite, which can cause allergic reactions in some individuals. If you experience any side effects, or if your cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, stop using the product and consult your doctor. You can also report side effects to the FDA at 1-800-FDA-1088.

Side Effects

You should be aware that this medication contains sodium metabisulfite, which can cause allergic reactions in some individuals. If you experience any side effects, it's important to stop using the medication and consult your doctor. Additionally, if your cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, these could be signs of a more serious condition, and you should seek medical advice promptly.

For any side effects you encounter, you can report them to the FDA at 1-800-FDA-1088.

Warnings and Precautions

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist. Additionally, be aware that this product contains sodium metabisulfite, which can cause allergic reactions in some people.

Before using this product, it's important to talk to your doctor if you have a chronic cough related to smoking, asthma, or emphysema, or if your cough produces a lot of mucus. You should stop using the product and contact your doctor if you experience any side effects, if your cough lasts more than seven days, or if it returns with fever, rash, or a persistent headache, as these may indicate a more serious issue. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately 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 right away. Your safety is the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

When giving medication to your child, it's important to follow the recommended dosages based on their age. For children aged 6 to under 12 years, the dosage is 5 mL every 12 hours, with a maximum of 10 mL in a 24-hour period. For those aged 4 to under 6 years, the dosage is 2.5 mL every 12 hours, not exceeding 5 mL in 24 hours. Please note that this medication should not be used for children under 4 years of age.

Always keep the medication out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 considering this medication, it’s important to consult with a healthcare provider. 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 may affect you if your kidneys are not functioning properly.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

Drug Interactions

It's important to be cautious when taking dextromethorphan, especially if you are also using a prescription monoamine oxidase inhibitor (MAOI), a type of medication often used for depression. You should avoid using dextromethorphan while on an MAOI or for at least two weeks after stopping it, as this combination can lead to serious health risks.

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

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20° to 25°C (68° to 77°F). This temperature range helps maintain the product's effectiveness and safety.

When using the product, a dosing cup is provided to help you measure the correct amount easily. Always handle the product with care to avoid contamination and ensure it remains safe for use.

Additional Information

You should take this medication orally. It's important to be aware that it contains sodium metabisulfite, which can cause allergic reactions in some people. If you are pregnant or breastfeeding, consult a healthcare professional before using this medication. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Dextromethorphan Polistirex used for?

Dextromethorphan Polistirex is a cough suppressant that temporarily relieves cough due to minor throat and bronchial irritation, such as that caused by the common cold or inhaled irritants.

Who can use Dextromethorphan Polistirex?

It is indicated for children ages 4 and older, as well as adults.

How should I take Dextromethorphan Polistirex?

Shake the bottle well before use and measure the dose with the provided dosing cup. Adults and children 12 years and older should take 10 mL every 12 hours, while children 6 to under 12 years should take 5 mL, and children 4 to under 6 years should take 2.5 mL.

Are there any warnings associated with Dextromethorphan Polistirex?

Yes, do not use it if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. It also contains sodium metabisulfite, which may cause allergic reactions.

What should I do if I experience side effects?

If side effects occur, stop use and ask a doctor. You can report side effects to the FDA at 1-800-FDA-1088.

Can I use Dextromethorphan Polistirex if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this product.

What should I do in case of an overdose?

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

How should Dextromethorphan Polistirex be stored?

Store Dextromethorphan Polistirex at 20° to 25°C (68° to 77°F).

Packaging Info

Below are the non-prescription pack sizes of Signature Care Childrens 12 Hour Cough Relief (dextromethorphan polistirex). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Signature Care Childrens 12 Hour Cough Relief.
Details

Drug Information (PDF)

This file contains official product information for Signature Care Childrens 12 Hour Cough Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with the common cold or as a result of inhaled irritants. Additionally, it is indicated for the temporary relief of the impulse to cough, facilitating sleep.

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

Dosage and Administration

The bottle should be shaken well before use. Dosing must be measured exclusively with the dosing cup provided; the dosing cup should not be used with any other products to ensure accurate measurement.

For adults and children aged 12 years and older, the recommended dose is 10 mL every 12 hours, with a maximum of 20 mL in a 24-hour period. For children aged 6 to under 12 years, the recommended dose is 5 mL every 12 hours, not to exceed 10 mL in a 24-hour period. For children aged 4 to under 6 years, the recommended dose is 2.5 mL every 12 hours, with a maximum of 5 mL in a 24-hour period. This product is not recommended for use in children under 4 years of age.

Healthcare professionals should ensure that patients adhere to these dosing guidelines or any alternative dosing as directed by a physician.

Contraindications

Use of this product is contraindicated in the following situations:

  • Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) is prohibited. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated for 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription contains an MAOI.

  • The product contains sodium metabisulfite, which may trigger allergic reactions in individuals with sulfite sensitivity.

Patients should discontinue use and seek medical advice if side effects occur, or if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or headache, as these may indicate a serious underlying condition.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Allergy Alert This product contains sodium metabisulfite, which is a sulfite that may provoke allergic-type reactions in susceptible individuals.

General Precautions Before using this product, patients should seek medical advice if they have a chronic cough associated with smoking, asthma, or emphysema, or if they experience a cough accompanied by excessive phlegm (mucus).

Stop Taking and Call Your Doctor Instructions Patients are advised to discontinue use and consult a healthcare provider if any side effects occur. Side effects can be reported to the FDA at 1-800-FDA-1088. Additionally, if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts, these may indicate a serious condition requiring medical evaluation.

Get Emergency Medical Help Instructions In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Side Effects

Patients may experience adverse reactions associated with the use of this medication. Notably, there is an Allergy Alert due to the presence of sodium metabisulfite, which is a sulfite that may lead to allergic-type reactions in susceptible individuals.

Patients are advised to discontinue use and consult a healthcare professional if any side effects occur. It is also recommended that patients seek medical attention if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or headache lasting longer than expected, as these symptoms may indicate a serious underlying condition.

For any adverse reactions, patients are encouraged to report side effects to the FDA at 1-800-FDA-1088.

Drug Interactions

The concomitant use of dextromethorphan with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take dextromethorphan while on MAOIs or for a period of two weeks following the discontinuation of MAOI therapy. This combination may result in serious interactions that could pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the aforementioned contraindication.

Packaging & NDC

Below are the non-prescription pack sizes of Signature Care Childrens 12 Hour Cough Relief (dextromethorphan polistirex). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Signature Care Childrens 12 Hour Cough Relief.
Details

Pediatric Use

Pediatric patients aged 4 years and older may use the product as indicated for cough relief. For children aged 6 to under 12 years, the recommended dosage is 5 mL every 12 hours, with a maximum of 10 mL in a 24-hour period. For children aged 4 to under 6 years, the dosage is 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours.

The product is not recommended for use in children under 4 years of age. It is essential to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and may need to implement specific protocols based on the substance taken. Continuous assessment and monitoring of vital signs are recommended to guide further treatment decisions.

In summary, prompt action and appropriate medical intervention are vital in the management of overdose cases to mitigate potential complications and ensure patient safety.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. The product contains sodium metabisulfite, which is a sulfite that may lead to allergic-type reactions in sensitive individuals.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is available in the insert.

Postmarketing Experience

Postmarketing experience has identified that the product contains sodium metabisulfite, which is a sulfite that may lead to allergic-type reactions in susceptible individuals. Users are advised to discontinue use and consult a healthcare professional if side effects occur. Additionally, it is recommended that individuals report any side effects to the FDA at 1-800-FDA-1088.

Reports indicate that if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or headache that lasts, these symptoms may indicate a serious underlying condition.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to inform patients that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should also be cautioned against using this product for two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist.

Providers should alert patients to the presence of sodium metabisulfite in the formulation, which may trigger allergic-type reactions in susceptible individuals. Patients must be instructed to discontinue use and consult a doctor if they experience any side effects. Additionally, they should be informed that side effects can be reported to the FDA at 1-800-FDA-1088.

Patients should be advised to stop using the product and seek medical advice if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts, as these symptoms may indicate a serious condition. It is also important for healthcare providers to recommend that patients consult a doctor before using this product if they have a chronic cough associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied with a dosing cup included for accurate measurement. It should be stored at a temperature range of 20° to 25°C (68° to 77°F) to ensure optimal stability and efficacy. Proper storage conditions are essential for maintaining the integrity of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should inform patients that the formulation contains sodium metabisulfite, which may trigger allergic-type reactions in susceptible individuals. Patients who are pregnant or breastfeeding should consult a healthcare professional prior to use. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Signature Care Childrens 12 Hour Cough Relief, 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 Childrens 12 Hour Cough Relief, 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.