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Childrens Cough

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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 2017
Label revision date
December 20, 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 2017
Label revision date
December 20, 2024
Manufacturer
Wal-Mart Stores, Inc.
Registration number
M012
NDC root
49035-773
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

Equate is a children's cough liquid designed for kids aged 4 to 12 years. It contains two active ingredients: Dextromethorphan HBr, which acts as a cough suppressant, and Guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions. This combination works to relieve chest congestion, control coughing, and make coughs more productive, allowing your child to breathe easier.

The cherry-flavored liquid is alcohol-free and non-drowsy, making it suitable for use during the day or night. It temporarily alleviates cough caused by minor throat and bronchial irritation, which can occur with colds or from inhaling irritants, helping your child get the rest they need.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. This makes it easier for your body to drain the bronchial tubes and can lead to more productive coughs.

It also provides temporary relief from coughing caused by minor throat and bronchial irritation, which can happen due to a cold or when you inhale irritants. If your child is having trouble sleeping because of a cough, this medication can help reduce the urge to cough, allowing for a more restful night. Additionally, it can lessen the intensity of coughing, making it more manageable.

Dosage and Administration

When using this medication, it's important to follow the dosing guidelines carefully to ensure safety and effectiveness. For children aged 6 years to under 12 years, you should give a dose of 5 mL to 10 mL every 4 hours. For younger children aged 4 years to under 6 years, the dose is smaller, ranging from 2.5 mL to 5 mL, also every 4 hours. However, if your child is under 4 years old, you should not use this medication.

Make sure to measure the doses using the dosing cup provided with the medication, as this ensures accuracy. It's crucial not to use this dosing cup with any other products to avoid confusion. Remember, you should not take more than 6 doses in a 24-hour period to prevent any potential overdose.

What to Avoid

You should avoid using this medication in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, psychiatric, or emotional conditions, or Parkinson's disease. Additionally, do not use this medication for at least two weeks after stopping an MAOI. If you're unsure whether your child's prescription includes an MAOI, it's important to consult with a doctor or pharmacist before administering this product.

Be mindful that misuse or abuse of this medication can lead to dependence (a condition where the body becomes reliant on a substance). Always follow these guidelines to ensure safety and effectiveness.

Side Effects

If you experience a cough that lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, it's important to stop using the medication and consult your doctor, as these could indicate a more serious condition.

Before using this medication, you should also talk to your doctor if you have a persistent or chronic cough, such as one associated with asthma, or if your cough is accompanied by excessive phlegm (mucus).

Warnings and Precautions

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial for your safety.

You should also stop using the medication and consult your doctor if your cough lasts more than 7 days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache. These could indicate a more serious health issue that needs attention.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have 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. 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.

Additionally, there are no specific dosage modifications mentioned for pregnant individuals, but seeking medical advice is strongly recommended to ensure your safety and that of your baby. Always prioritize open communication with your healthcare provider regarding any medications or products you consider using during pregnancy.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

Pediatric Use

It's important to be cautious when giving this medication to children. You should not use it if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication for depression or certain other conditions, or if they have stopped taking it within the last two weeks. If you're unsure whether your child's medication includes an MAOI, please consult with a doctor or pharmacist.

For dosing, children aged 6 to under 12 years can take 5 mL to 10 mL every 4 hours, while those aged 4 to under 6 years should take 2.5 mL to 5 mL every 4 hours. However, this medication is not recommended for children under 4 years old. If your child's cough lasts more than 7 days, returns, or is accompanied by a fever, rash, or persistent headache, stop using the medication and contact a doctor, as these could indicate a more serious health issue.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available regarding its safety or effectiveness. This means that if you or a loved one is an older adult, it's important to consult with a healthcare provider before starting the medication. They can help assess any potential risks and determine the best approach based on individual health needs. 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 you may need a lower dose of this medication. Your doctor will determine the right dosage based on your creatinine clearance, which is a test that measures how well your kidneys are filtering waste from your blood.

To ensure your kidneys remain healthy while taking this medication, regular renal function tests are recommended. If you have severe kidney impairment, your healthcare provider will need to monitor you more closely to adjust your treatment as necessary. Always communicate with your doctor about your kidney health and any concerns you may have.

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 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 on a monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression or other mental health conditions. Additionally, you should wait at least two weeks after stopping an MAOI before giving this medication. If you're unsure whether your child's prescription includes an MAOI, it's best to consult with a doctor or pharmacist.

While there are no specific laboratory test interactions noted, discussing all medications and any tests your child may undergo with a healthcare provider is crucial. This ensures their safety and helps avoid any potential complications. Always prioritize open communication with your healthcare team regarding your child's health and medications.

Storage and Handling

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

When using the product, a dosing cup is provided to help you measure the correct amount safely. Always handle the product with care to maintain its quality and effectiveness.

Additional Information

You will 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 equate?

Equate is a children's cough liquid that contains Dextromethorphan HBr (5 mg) as a cough suppressant and Guaifenesin (100 mg) as an expectorant.

What age group can use equate?

Equate is intended for children aged 4 to 12 years.

How does equate work?

Equate helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and relieving chest congestion.

What are the dosage recommendations for equate?

For children 6 years to under 12 years, the dose is 5 mL to 10 mL every 4 hours. For children 4 years to under 6 years, the dose is 2.5 mL to 5 mL every 4 hours. Do not use in children under 4 years.

Are there any contraindications for using equate?

Do not use equate in children taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

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

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

Is equate safe to use during pregnancy?

The safety of equate during pregnancy has not been established, so consult a doctor before use if pregnant or planning to become pregnant.

How should equate be stored?

Store equate between 20 to 25°C (68 to 77°F) and do not refrigerate.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

Packaging Info

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

Packaging configurations for Childrens Cough.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product, identified by NDC 49035-773-03, is a cough relief formulation designed for children aged 4 to 12 years. It contains the active ingredients dextromethorphan HBr at a concentration of 5 mg, serving as a cough suppressant, and guaifenesin at 100 mg, functioning as an expectorant. The formulation is designed to control cough, thin and loosen mucus, and relieve chest congestion. It is presented in a 4 fluid ounce (118 mL) dosage form, is alcohol-free, and features a cherry flavor. The product is non-drowsy, making it suitable for use during the day.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to colds or inhaled irritants. It aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the drainage of bronchial tubes and enhancing the productivity of coughs.

Additionally, this drug temporarily alleviates the impulse to cough, assisting children in achieving restful sleep, and reduces the intensity of coughing episodes.

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

Dosage and Administration

Healthcare professionals should adhere to the following dosage and administration guidelines.

For children aged 6 years to under 12 years, the recommended dose is 5 mL to 10 mL, administered every 4 hours as needed. For children aged 4 years to under 6 years, the appropriate dose is 2.5 mL to 5 mL, also given every 4 hours as necessary.

It is imperative that no more than 6 doses are taken within a 24-hour period. Dosing should be measured exclusively with the dosing cup provided with the product, and this cup should not be used for measuring other products to ensure accurate dosing.

For children under 4 years of age, the product is not recommended for use.

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

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. This is crucial to ensure the safety and well-being of the patient.

Healthcare professionals are advised to instruct patients to discontinue use and consult a physician if a cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires further evaluation and intervention.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. While no specific side effects are listed in the warnings section, it is important for patients to be vigilant regarding their symptoms.

Patients should stop use and consult a doctor if their cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying illness.

Additionally, patients are advised to seek medical advice before using this product if they have a persistent or chronic cough, such as that which occurs with asthma, or if they experience a cough that is associated with excessive phlegm (mucus). These considerations are crucial for ensuring patient safety and effective management of their symptoms.

Drug Interactions

The use of this product is contraindicated in pediatric patients who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric disorders, emotional conditions, or Parkinson's disease. Additionally, this product should not be administered for a period of two weeks following the discontinuation of an MAOI. It is advised that caregivers consult a healthcare professional, such as a doctor or pharmacist, to confirm whether their child's prescription includes an MAOI before administering this product.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

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

Packaging configurations for Childrens Cough.
Details

Pediatric Use

Pediatric patients aged 6 years to under 12 years may receive a dosage of 5 mL to 10 mL every 4 hours, while those aged 4 years to under 6 years should be administered 2.5 mL to 5 mL every 4 hours. The product is contraindicated in children under 4 years of age.

It is critical to avoid use in any child currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Caregivers should consult a healthcare professional if there is uncertainty regarding the presence of an MAOI in the child's prescription.

Healthcare providers should advise parents to discontinue use and seek medical attention if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to closely monitor this population for any potential adverse effects or changes in efficacy, as age-related physiological changes may influence drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and concurrent medications that are common in geriatric patients, which may necessitate dosage adjustments or increased monitoring.

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 prior to use, as there may be potential risks to the fetus. Specific studies or data regarding fetal outcomes are not provided in the prescribing information. No dosage modifications for pregnant individuals are mentioned. It is strongly advised that medical advice be sought before using this product during pregnancy to ensure the safety of both the patient and the developing fetus.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment may require a reduced dose of the medication. Dosage adjustments should be based on creatinine clearance to ensure appropriate therapeutic levels while minimizing the risk of adverse effects. Regular renal function tests are recommended to monitor kidney health in patients receiving this medication. Additionally, special monitoring is necessary for patients with severe renal impairment to ensure safety and efficacy.

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 absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and consider general principles of management for suspected overdosage cases.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be prioritized.

Potential Symptoms While specific symptoms related to overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the lack of documented information.

Management Procedures Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on the management of overdosage cases. Supportive measures, including the administration of activated charcoal if appropriate, may be considered based on the clinical scenario and timing of the overdose.

In summary, due to the absence of specific overdosage information, a cautious and supportive approach is recommended, with an emphasis on monitoring and symptomatic management.

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 seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that this medication should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two 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.

Providers should instruct patients to discontinue use and consult a doctor if a cough persists for more than seven days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition. Additionally, patients should be advised to seek medical advice before using this product if they have a persistent or chronic cough, particularly one associated with asthma, or if they are experiencing a cough that produces excessive phlegm (mucus).

Storage and Handling

The product is supplied in a configuration that includes a dosing cup. It is essential to store the product at a temperature range of 20 to 25°C (68 to 77°F). Refrigeration is not recommended, as the product should not be stored in cold conditions. Proper handling and storage are crucial to maintain the integrity and efficacy 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 Childrens Cough, 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 Childrens Cough, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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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.