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Giltuss Childrens Cough and Cold

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Active ingredients
  • Guaifenesin 150 mg/2.5 mL
  • Dextromethorphan Hydrobromide 7.5 mg/2.5 mL
  • Phenylephrine Hydrochloride 5 mg/2.5 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
September 17, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 150 mg/2.5 mL
  • Dextromethorphan Hydrobromide 7.5 mg/2.5 mL
  • Phenylephrine Hydrochloride 5 mg/2.5 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
September 17, 2025
Manufacturer
Dextrum Laboratories Inc.
Registration number
M012
NDC root
65852-011
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

Giltuss Children C and C is a medication designed specifically for children aged 4 to 12 years to help relieve cough and cold symptoms. This product is alcohol-free, sugar-free, and dye-free, making it a gentle option for young ones. It has a pleasant cherry flavor and is formulated to be non-drowsy, allowing your child to feel better without feeling sleepy.

While there are no specific details about how it works, Giltuss Children C and C is intended to provide relief from discomfort associated with coughs and colds. Always follow the recommended dosage guidelines to ensure safe and effective use for your child.

Uses

If your child is between the ages of 4 and 12 and is experiencing symptoms of a cough or cold, this medication can be used to help alleviate those symptoms. It's specifically designed for children in this age group, making it a suitable option for managing their discomfort during cold and cough episodes.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safe choice for your child when used as directed.

Dosage and Administration

When using this medication, it's important to follow the correct dosage to ensure safety and effectiveness. You should not take more than 6 doses within a 24-hour period. To measure your dose accurately, use the enclosed dosing cup, and keep it for future use with this product.

For children, the dosage varies by age. If your child is under 4 years old, it's best to consult a doctor before giving them this medication. For children aged 4 to under 6 years, the recommended dose is 1.25 ml every 4 hours. If your child is between 6 and under 12 years, they should take 2.5 ml every 4 hours. For those 12 years and older, the dosage increases to 5 ml every 4 hours. Always ensure you are measuring the dose correctly to keep your child safe.

What to Avoid

Before using this product, it's important to consult 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 related to asthma or chronic bronchitis. Additionally, if your child is taking other medications such as nasal decongestants, stimulants, sedatives, tranquilizers, or certain antidepressants (especially monoamine oxidase inhibitors, or MAOIs), please check with a healthcare professional first.

Make sure to follow the dosing instructions carefully and do not exceed the recommended amount. If your child experiences nervousness, dizziness, or trouble sleeping, or if symptoms do not improve within 7 days, or if they develop a fever, persistent cough, rash, or headache, stop using the product and consult a doctor. These could indicate more serious health issues.

Side Effects

It's important to be aware of potential side effects when using this medication for your child. You should avoid using it if your child is currently taking a 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.

Before giving this medication, consult a doctor if your child has any of the following: heart disease, high blood pressure, thyroid disease, diabetes, or a cough with excessive mucus. Additionally, if your child is taking other medications, especially nasal decongestants, stimulants, sedatives, or MAOIs, it's crucial to check with a healthcare professional first. If your child experiences nervousness, dizziness, or sleeplessness, or if their symptoms do not improve within a week, you should stop using the medication and seek medical advice.

Warnings and Precautions

You should not use this product if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, or Parkinson's disease, or if they have stopped taking an MAOI within the last two weeks. If you're unsure whether your child's medication contains an MAOI, please consult a doctor or pharmacist.

Before using this product, it's important to check with a doctor if your child has any heart issues, high blood pressure, thyroid problems, diabetes, or a cough that produces a lot of mucus. Also, consult a healthcare professional if your child is taking other nasal decongestants, stimulants, sedatives, tranquilizers, or antidepressants, especially MAOIs. Always follow the dosage instructions carefully and do not exceed the recommended amount.

If your child accidentally takes too much, seek emergency medical help or contact a Poison Control Center right away. You should stop using the product and call your doctor if your child experiences nervousness, dizziness, or trouble sleeping; if symptoms do not improve within 7 days; or if a cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these may indicate a more serious issue.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect that you or someone else may have taken too much of a medication, it’s important to be aware of potential signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms, or if you have concerns about a possible overdose, seek immediate medical help. You can contact your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any risks.

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 keep this medication out of reach of children to prevent accidental ingestion.

In the event of an accidental overdose, seek medical assistance or contact a Poison Control Center right away. Your health and safety, as well as that of your child, are paramount, so don’t hesitate to reach out for help if needed.

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 your child has a cough from a common cold or irritation in their throat and bronchial tubes, this medication can provide temporary relief. It works by loosening mucus and thinning secretions, which helps make the cough more productive and clears the bronchial tubes. Additionally, it can help relieve nasal congestion, making it easier for your child to breathe when they have a stuffy nose.

Always consult with your child's healthcare provider before giving any medication, especially if your child is very young or has other health conditions. It's important to follow the recommended dosage and guidelines to ensure your child's safety and comfort.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to remember that each individual may respond differently to treatments. Since the insert does not mention any recommended age considerations, dosage adjustments, or safety concerns for elderly patients, you should always consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is appropriate for your unique health needs and circumstances.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be cautious when your child is taking certain medications. Specifically, you should not use this product if your child is currently on a prescription monoamine oxidase inhibitor (MAOI) or has stopped taking one within the last two weeks, as this can lead to serious interactions.

Before using this product, always consult with a doctor or pharmacist if your child is taking any other nasal decongestants, stimulants, sedatives, tranquilizers, or medications for depression, particularly MAOIs. Discussing all medications and treatments with a healthcare provider helps ensure your child's safety and well-being.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 15 to 30 °C (59 to 86 °F). After each use, make sure to close the cap tightly to maintain its integrity and effectiveness. It's also a good idea to keep the original carton, as it contains important information about the product that you may need later.

By following these simple storage and handling guidelines, you can help ensure the safety and efficacy of your product.

Additional Information

You should take this medication orally. If you have children, the dosage varies by age: for children under 4 years, consult a doctor; for those aged 4 to under 6 years, give 1.25 ml every 4 hours; for children aged 6 to under 12 years, give 2.5 ml every 4 hours; and for those 12 years and older, the dosage is 5 ml every 4 hours.

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this medication. Always keep it out of reach of children, and in case of an accidental overdose, seek medical help or contact a Poison Control Center immediately.

FAQ

What is Giltuss Children C and C used for?

Giltuss Children C and C is indicated for cough and cold relief in children aged 4 to 12 years.

Is Giltuss Children C and C safe for children under 4 years?

You should consult a doctor before using Giltuss Children C and C for children under 4 years.

What is the recommended dosage for children aged 4 to under 6 years?

Children aged 4 to under 6 years should take 1.25 ml every 4 hours.

How often can I give Giltuss Children C and C?

You should not give more than 6 doses in any 24-hour period.

What should I do if my child experiences nervousness or dizziness?

Stop using the product and ask a doctor if your child experiences nervousness, dizziness, or sleeplessness.

Can I use Giltuss Children C and C if my child is taking other medications?

You should ask a doctor or pharmacist before use if your child is taking any other nasal decongestants, stimulants, sedatives, tranquilizers, or drugs for depression, especially monoamine oxidase inhibitors (MAOIs).

What should I do in case of accidental overdose?

In case of accidental overdose, get medical or professional help or contact a Poison Control Center immediately.

Is Giltuss Children C and C alcohol-free?

Yes, Giltuss Children C and C is alcohol-free, sugar-free, and dye-free.

What flavor does Giltuss Children C and C have?

Giltuss Children C and C has a cherry flavor.

What should I do if my child's cough lasts more than 7 days?

If your child's cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache, stop use and ask a doctor.

Packaging Info

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

Packaging configurations for Giltuss Childrens Cough and Cold.
Details

Drug Information (PDF)

This file contains official product information for Giltuss Childrens Cough and 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 and cold symptoms in children aged 4 to 12 years.

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

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. Healthcare professionals should advise patients to utilize the enclosed dosing cup, which should be retained for future use with this product.

For administration, the following guidelines should be adhered to based on the patient's age:

  • For children under 4 years of age, consultation with a healthcare provider is required prior to use.

  • For children aged 4 to under 6 years, the recommended dosage is 1.25 ml every 4 hours.

  • For children aged 6 to under 12 years, the recommended dosage is 2.5 ml every 4 hours.

  • For children aged 12 years and older, the recommended dosage is 5 ml every 4 hours.

It is essential to ensure that the dosing intervals are strictly followed to avoid exceeding the maximum daily limit.

Contraindications

Use of this product is contraindicated in children with the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, excessive phlegm production, or a persistent or chronic cough, such as that associated with asthma or chronic bronchitis.

Additionally, consultation with a healthcare professional is advised prior to use if the child is currently taking any other nasal decongestants, stimulants, sedatives, tranquilizers, or antidepressants, particularly monoamine oxidase inhibitors (MAOIs).

The product should not be used in excess of the directed dosage. Discontinue use and seek medical advice if the child experiences nervousness, dizziness, or sleeplessness; if symptoms do not improve within 7 days; or if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these may indicate serious underlying conditions.

Warnings and Precautions

The use of this product is contraindicated in children 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 administered for a period of two weeks following the cessation of an MAOI. 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 has a history of heart disease, high blood pressure, thyroid disease, diabetes, or if they present with a cough that produces excessive phlegm or a persistent cough associated with asthma or chronic bronchitis. Furthermore, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently using any other nasal decongestants, stimulants, sedatives, tranquilizers, or antidepressants, particularly MAOIs. It is imperative to adhere strictly to the recommended dosage and not exceed the directed amount when using this product.

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

Caregivers are advised 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, or if a cough persists for more than seven days, recurs, or is associated with fever, rash, or a persistent headache, these may indicate serious underlying conditions that require medical evaluation.

Side Effects

Patients using this medication may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Serious adverse reactions may include symptoms such as nervousness, dizziness, or sleeplessness. If any of these symptoms occur, patients should discontinue use and consult a healthcare professional. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, or if a cough persists for more than 7 days, recurs, or is associated with fever, rash, or a persistent headache, patients are advised to seek medical attention, as these may indicate serious underlying conditions.

Common adverse reactions may arise in patients with pre-existing health conditions. It is recommended that patients consult a doctor prior to use if they have heart disease, high blood pressure, thyroid disease, diabetes, or a cough with excessive phlegm. Furthermore, patients with a persistent or chronic cough, such as that associated with asthma or chronic bronchitis, should also seek medical advice before using this medication.

Patients should be particularly cautious if they are currently taking any other nasal decongestants, stimulants, sedatives, tranquilizers, or drugs for depression, especially monoamine oxidase inhibitors (MAOIs). The use of this medication is contraindicated in children who are currently taking a prescription MAOI or have stopped taking one within the past two weeks.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Administration of this drug is not recommended if the patient is currently taking an MAOI or has discontinued an MAOI within the past two weeks, as this may result in serious interactions.

Additionally, it is advisable to consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication if the patient is concurrently taking any other nasal decongestants, stimulants, sedatives, tranquilizers, or medications prescribed for depression, particularly MAOIs. Monitoring for potential adverse effects is recommended in these cases.

Packaging & NDC

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

Packaging configurations for Giltuss Childrens Cough and Cold.
Details

Pediatric Use

Pediatric patients may use this medication for the temporary relief of cough associated with minor throat and bronchial irritation, which can occur with the common cold or inhaled irritants. It aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby making coughs more productive and facilitating the drainage of bronchial tubes. Additionally, it provides temporary relief from nasal congestion due to colds and stuffy noses.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age considerations, dosage adjustments, safety concerns, or special precautions pertinent to this population.

Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the absence of data specific to this demographic. Monitoring for efficacy and safety in elderly patients is advised, given the general considerations for pharmacotherapy in this age group.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. It is important to ensure that the potential benefits outweigh any risks associated with the use of this medication during pregnancy or lactation.

In the event of an accidental overdose, immediate medical attention should be sought, or contact with a Poison Control Center is advised. Additionally, this medication should be kept out of reach of children to prevent unintentional exposure.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human 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 not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with reduced kidney function, as the absence of specific guidance necessitates careful clinical judgment.

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 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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with any medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and healthcare professionals should ensure that the patient is stabilized. This may involve monitoring vital signs, providing intravenous fluids, and administering symptomatic treatment as necessary.

In the event of an overdose, contacting a poison control center or a medical toxicologist for guidance on specific interventions and antidotes is recommended. Prompt and appropriate management can significantly improve patient outcomes in cases of suspected overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Reports of side effects have been received through voluntary submissions and surveillance programs. Patients are advised to contact their healthcare provider for medical advice regarding any adverse events experienced.

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 accidental overdose, patients should be instructed to seek medical assistance or contact a Poison Control Center immediately.

Providers should recommend that patients consult a doctor before using this product if their child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, a cough with excessive phlegm, or a persistent or chronic cough associated with asthma or chronic bronchitis.

It is also important for healthcare providers to remind patients to ask a doctor or pharmacist before use if their child is currently taking any other nasal decongestants, stimulants, sedatives, tranquilizers, or medications for depression, particularly monoamine oxidase inhibitors (MAOIs).

Patients should be cautioned to adhere strictly to the recommended dosage and not exceed the directed amount. Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days, or if they are accompanied by fever, or if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, patients should seek medical advice, as these may indicate serious conditions.

Storage and Handling

The product is supplied in a configuration that includes a tightly sealed cap to ensure integrity after each use. It is essential to store the product at room temperature, specifically within the range of 15 to 30 °C. For comprehensive drug information, healthcare professionals are advised to retain the carton in which the product is packaged.

Additional Clinical Information

The medication is administered orally, with specific dosing recommendations based on age. For children under 4 years, consultation with a doctor is advised. Children aged 4 to under 6 years should receive 1.25 ml every 4 hours, while those aged 6 to under 12 years should receive 2.5 ml every 4 hours. For patients aged 12 years and older, the recommended dose is 5 ml every 4 hours.

Clinicians should counsel patients on important safety information. Pregnant or breastfeeding individuals should consult a health professional prior to use. It is crucial to keep the medication out of reach of children, and in the event of an accidental overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Giltuss Childrens Cough and 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 Giltuss Childrens Cough and 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.

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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.