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Sanatos Children Cough and Congestion Cherry

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Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
May 2, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
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 2016
Label revision date
May 2, 2024
Manufacturer
Pharmadel LLC
Registration number
M012
NDC root
55758-013
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

This medication is designed to temporarily relieve cough caused by minor irritation in the throat and bronchial tubes, which can happen with a common cold. It works by helping to loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to drain your bronchial tubes and breathe more comfortably.

Uses

You can use this medication to temporarily relieve a cough caused by minor irritation in your throat and bronchial tubes, which often happens with a common cold. Additionally, it helps to loosen phlegm (mucus) and thin out bronchial secretions, making it easier for your body to drain the bronchial tubes. This can provide you with some comfort when you're feeling under the weather.

Dosage and Administration

When giving this medication to children, it's important to follow the correct dosage to ensure their safety. For children aged 6 to under 12 years, you can give them 1 to 2 teaspoonfuls (tsps) every 4 hours, but make sure not to exceed 6 doses in a 24-hour period. If your child is between 2 and under 6 years old, the recommended dose is ½ to 1 teaspoonful every 4 hours, again ensuring that the total does not go over 6 doses in a day.

For children under 2 years of age, it's best to consult a doctor before administering any medication. This way, you can ensure that your little one receives the appropriate care and dosage tailored to their needs. Always keep track of how many doses your child has taken within a day to avoid giving too much.

What to Avoid

You should avoid using this medication in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which are specific drugs used for treating depression, psychiatric, or emotional conditions, as well as Parkinson's disease. Additionally, do not give this medication to a child for at least two weeks after they have stopped taking an MAOI. If you're unsure whether your child's prescription includes an MAOI, it's important to consult with a doctor or pharmacist before administering this product.

Taking this medication inappropriately can lead to serious health risks, so please follow these guidelines carefully to ensure your child's safety.

Side Effects

It's important to be aware of potential side effects when using this medication. You should 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, consult a doctor or pharmacist.

Before using this product, check with a doctor if your child has a cough with excessive mucus or a chronic cough, such as one caused by asthma. If your child's cough lasts more than seven days, comes back frequently, or is accompanied by fever, rash, or a persistent headache, stop using the medication and seek medical advice, as these could indicate a more serious issue. In case of an overdose, it's crucial to get medical help or contact a Poison Control Center immediately.

Warnings and Precautions

It's important to be cautious when giving this medication to children. Do not use it if your child is taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication for depression or certain other conditions, or if they have stopped taking an MAOI within the last two weeks. 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 a cough that produces a lot of mucus or if they have a persistent cough, such as one associated with asthma. If your child's cough lasts more than 7 days, comes back frequently, or is accompanied by fever, rash, or a persistent headache, stop using the medication and contact a doctor, as these could indicate a more serious issue. In the event of an overdose, seek 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 what you would typically experience with the medication.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always keep emergency contact information handy, and remember that it’s better to be cautious and seek help if you have any concerns about an overdose.

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. You should consult your doctor before using it, as there may be potential risks to your fetus, and further studies are needed to fully understand these risks.

Currently, there are no specific dosage modifications recommended for pregnant women, so it's essential to seek guidance from a healthcare professional regarding its use. Always prioritize your health and the health of your baby by discussing any medications with your doctor.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to exercise caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

It's important to be cautious when giving medication to children. If your child is taking a prescription monoamine oxidase inhibitor (MAOI), do not use this medication, and wait at least two weeks after stopping the MAOI before considering it. Always consult a doctor if your child has a cough with excessive mucus or a chronic cough, such as one associated with asthma. If your child's cough lasts more than seven days, comes back frequently, or is accompanied by a fever, rash, or persistent headache, stop using the medication and seek medical advice.

For dosing, children aged 6 to under 12 years can take 1-2 teaspoonfuls every four hours, while those aged 2 to under 6 years should have ½-1 teaspoonful every four hours. For children under 2 years, it's essential to consult a doctor before administering any medication. Remember, do not give more than six doses in a 24-hour period.

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 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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to be cautious when giving medications to children, especially if they are taking certain prescription drugs. For instance, you should not use this medication in a child who is currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, psychiatric conditions, or Parkinson's disease. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your child's prescription includes an MAOI, it's best to consult with a doctor or pharmacist before proceeding.

Always discuss any medications or tests with your healthcare provider to ensure safety and effectiveness. They can help you understand potential interactions and make informed decisions about your child's health.

Storage and Handling

To ensure the best performance of your product, store it at room temperature between 20-25º C (68-77º F). It's important not to refrigerate the product, as this can affect its effectiveness.

When using the product, you will find a dosage cup included, which helps you measure the correct amount safely. Always handle the product with care to maintain its quality and effectiveness.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug temporarily relieves cough due to minor throat and bronchial irritation, such as that caused by a common cold.

How does this drug help with cough?

It helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tubes.

What should I do if my child is taking a monoamine oxidase inhibitor (MAOI)?

Do not use this drug in a child who is taking an MAOI or for 2 weeks after stopping the MAOI. Consult a doctor or pharmacist if unsure.

What is the maximum number of doses I can give my child in 24 hours?

Do not give a child more than 6 doses in any 24-hour period.

What is the recommended dosage for children aged 6 to under 12 years?

Children aged 6 to under 12 years should take 1-2 teaspoonfuls (tsps) every 4 hours.

What should I do if my child has a cough that lasts more than 7 days?

Stop use and ask a doctor if the cough lasts more than 7 days, tends to recur, or is accompanied by fever, rash, or a persistent headache.

Is this drug safe to use during pregnancy?

The safety of this product during pregnancy has not been established, and there may be potential risks to the fetus.

What should nursing mothers do before using this drug?

Nursing mothers should consult a doctor before using this product due to potential excretion in breast milk.

How should this drug be stored?

Store at 20-25º C (68-77º F) and do not refrigerate.

Packaging Info

Below are the non-prescription pack sizes of Sanatos Children Cough and Congestion Cherry (dextromethorphan hbr and guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sanatos Children Cough and Congestion Cherry.
Details

Drug Information (PDF)

This file contains official product information for Sanatos Children Cough and Congestion Cherry, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Saantos Children CC is identified by the SPL code 34089-3. This formulation is specifically designed for pediatric use, providing a targeted therapeutic option for children. The product's composition and characteristics are tailored to meet the unique needs of this population.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to a common cold. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage from the bronchial tubes.

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

Dosage and Administration

For children aged 6 to under 12 years, the recommended dosage is 1 to 2 teaspoonfuls (tsps) administered every 4 hours. It is important to note that no more than 6 doses should be given within a 24-hour period.

For children aged 2 to under 6 years, the dosage is ½ to 1 teaspoonful (tsp) every 4 hours, adhering to the same maximum limit of 6 doses in a 24-hour period.

For children under 2 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this product should not be administered for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a child's prescription medication, consultation with a healthcare professional, such as a doctor or pharmacist, is advised prior to use.

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 an MAOI 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.

General precautions should be observed prior to administration. It is essential to consult a healthcare provider if the child presents with a cough that is accompanied by excessive phlegm (mucus) or if the cough is persistent or chronic, as may occur in cases of asthma.

Caregivers should be instructed to discontinue use and seek medical advice if the child experiences a cough lasting more than seven days, if the cough recurs, or if it is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay to ensure the child's safety.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. It is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks following the discontinuation of 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, it is essential to consult a healthcare professional before administering this product.

Before use, it is advisable to consult a doctor if the child has a cough accompanied by excessive phlegm or a persistent or chronic cough, such as that which occurs with asthma.

Parents and caregivers should discontinue use and seek medical advice if the child experiences a cough lasting more than seven days, if the cough tends to recur, or if it is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated in pediatric patients. MAOIs are typically prescribed for the treatment of depression, psychiatric disorders, or Parkinson's disease. Administration of this product should be avoided in children who are currently taking an MAOI or within 14 days of discontinuing such therapy.

Healthcare professionals are advised to confirm whether a child's prescription includes an MAOI prior to the administration of this product. If there is any uncertainty regarding the presence of an MAOI in the child's medication regimen, consultation with a physician or pharmacist is recommended to ensure patient safety.

Packaging & NDC

Below are the non-prescription pack sizes of Sanatos Children Cough and Congestion Cherry (dextromethorphan hbr and guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sanatos Children Cough and Congestion Cherry.
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 advisable to consult a healthcare professional if the child has a cough accompanied by excessive phlegm or a persistent cough, such as that associated with asthma.

If a child's cough lasts more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, the use of this medication should be discontinued, and a doctor should be consulted.

Dosing recommendations vary by age: for children aged 6 to under 12 years, the dosage is 1-2 teaspoonfuls every 4 hours, while for those aged 2 to under 6 years, the dosage is ½-1 teaspoonful every 4 hours. For children under 2 years of age, consultation with a doctor is required before use. It is important to ensure that no more than 6 doses are administered in any 24-hour period.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use, as there may be potential risks to the fetus. Further studies are needed to determine the safety profile of this product in pregnant populations. Currently, no specific dosage modifications for pregnant women are provided; therefore, healthcare professionals should be consulted for guidance on appropriate use in this population.

Lactation

Nursing mothers should consult a doctor 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 may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. 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 and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available 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 aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients and caregivers to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform them 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 there is uncertainty regarding whether a child's prescription includes an MAOI, patients should be encouraged to consult with a doctor or pharmacist prior to administering this product.

Providers should instruct caregivers to discontinue use and consult a doctor if the child experiences a cough lasting more than seven days, if the cough recurs, or if it is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious condition. Additionally, it is important to recommend that caregivers seek medical advice before using this product if the child has a cough associated with excessive phlegm (mucus) or if the child has a persistent or chronic cough, such as that which occurs with asthma.

Storage and Handling

The product is supplied with a dosage cup included for accurate measurement. It should be stored at a temperature range of 20-25º C (68-77º F). It is important to note that refrigeration is not recommended for this product. Proper storage conditions will help maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Sanatos Children Cough and Congestion Cherry, 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 Sanatos Children Cough and Congestion Cherry, 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.