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Texaclear Kids Daytime Cough and Chest Congestion

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This product has been discontinued

Active ingredients
  • Guaifenesin 100 mg/15 mL
  • Dextromethorphan Hydrobromide 5 mg/15 mL
Other brand names
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 2023
Label revision date
October 7, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 100 mg/15 mL
  • Dextromethorphan Hydrobromide 5 mg/15 mL
Other brand names
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 2023
Label revision date
October 7, 2024
Manufacturer
GM Pharmaceuticals, INC
Registration number
M012
NDC root
58809-216
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

TexaClear Kids Daytime Cough and Chest Congestion is a medication designed for children aged 4 and older to help relieve cough and chest congestion. It contains two active ingredients: dextromethorphan HBr, which acts as a cough suppressant to temporarily reduce the intensity of coughing, and guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions. This combination makes it easier for you to clear mucus from the bronchial passageways, leading to more productive coughs and relief from minor throat and bronchial irritation often associated with the common cold or inhaled irritants.

This product is formulated to be free from dyes, sugar, gluten, alcohol, and acetaminophen, making it a gentle option for your child's needs.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. This action helps clear out bothersome mucus from your airways, making your coughs more productive.

Additionally, it provides temporary relief from the intensity of coughing and can soothe coughs caused by minor throat and bronchial irritation, which may happen due to the common cold or exposure to irritants in the air.

Dosage and Administration

When using this medication, it's important to follow the dosing guidelines carefully to ensure safety and effectiveness. You should not take more than 6 doses within a 24-hour period. Always measure your dose using the dosing cup provided, as this ensures you get the correct amount. Remember, 1 mL (milliliter) is a unit of measurement for liquid volume.

For children aged 6 years to under 12 years, the recommended dose is 30 mL, which is equivalent to 2 dose cups, taken every 4 hours. If your child is between 4 years and under 6 years, the dose is 15 mL, or 1 dose cup, also every 4 hours. However, if your child is under 4 years old, this medication should not be used. Always consult with a healthcare professional if you have any questions or concerns about dosing.

What to Avoid

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

Be mindful that misuse or abuse of this product can lead to dependence (a condition where the body becomes reliant on a substance). Always follow these guidelines to ensure your child's safety and well-being.

Side Effects

You should be aware of some potential side effects and important warnings associated with this medication. It's crucial not to exceed the recommended dosage. If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, you should stop using the medication and consult a doctor, as these may indicate a more serious condition.

Before using this medication for a child, it's advisable to consult a doctor if the child has a persistent cough (like that seen in asthma), a cough with excessive mucus, or is on a sodium-restricted diet. In the event of an overdose, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

It's important to follow the recommended dosage when using this medication. If your child is taking a prescription monoamine oxidase inhibitor (MOAI) for conditions like depression or Parkinson's disease, do not use this product, and wait at least two weeks after stopping the MOAI before giving it. If you're unsure whether your child's medication contains an MAOI, please consult a doctor or pharmacist.

Before using this medication, check with a doctor if your child has a persistent cough, a cough with excessive mucus, or is on a sodium-restricted diet. If your child experiences an overdose, seek emergency medical help or contact a Poison Control Center immediately. Additionally, if the cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, stop using the medication and call your doctor, as these may indicate a more serious condition.

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 and health. Always keep emergency contact information handy, and remember that it’s better to be safe and get help if you’re unsure.

Pregnancy Use

The safety of TexaClear Kids Daytime Cough and Chest Congestion during pregnancy has not been established, meaning there isn't enough information to confirm whether it is safe for you and your developing baby. While there are no specific contraindications (conditions that would prevent use) or dosage modifications mentioned for pregnant individuals, it's important to be cautious. The insert does not provide details about potential risks to the fetus, nor does it outline any special precautions for use during pregnancy.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication, including over-the-counter products like TexaClear. They can help you weigh the benefits and risks based on your individual health needs.

Lactation Use

If you are breastfeeding, you can use TexaClear Kids Daytime Cough and Chest Congestion without specific warnings or recommendations against it. Currently, there is no information available about whether this medication passes into breast milk or if it poses any risk to your nursing infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

You should avoid giving this medication to your child if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one in the past two weeks. Before using the medication, consult your doctor if your child has a persistent cough (like one caused by asthma), a cough with excessive mucus, or is on a sodium-restricted diet.

If your child's cough lasts more than seven days, returns, or is accompanied by a fever, rash, or a persistent headache, stop using the medication and seek medical advice. For dosing, children aged 6 to under 12 years can take 30 mL (2 dose cups) every 4 hours, while those aged 4 to under 6 years should take 15 mL (1 dose cup) every 4 hours. This medication is not recommended for children under 4 years old.

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, it’s important to consult with a healthcare provider for personalized advice. 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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you or how your liver function might influence the treatment.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have about your liver health and how it relates to your medication. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's crucial to be aware of potential interactions when considering medications for yourself or your child. For instance, you should not use this medication if your child is currently taking a monoamine oxidase inhibitor (MAOI), which is a type of prescription drug often used for depression, certain psychiatric conditions, or Parkinson's disease. Additionally, you should wait at least two weeks after stopping an MAOI before using this medication. If you're unsure whether your child's prescription includes an MAOI, it's important to consult with a doctor or pharmacist before proceeding.

Always discuss any medications or treatments with your healthcare provider to ensure safety and effectiveness. They can help you navigate potential interactions and make informed decisions about your health.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, specifically between 20-30°C (68-86°F). This temperature range helps maintain its effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

No further information is available.

FAQ

What is TexaClear Kids Daytime Cough and Chest Congestion used for?

TexaClear Kids Daytime Cough and Chest Congestion helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and temporarily relieving coughing due to minor throat and bronchial irritation.

What are the active ingredients in TexaClear Kids?

The active ingredients are Dextromethorphan HBR, which is a cough suppressant, and Guaifenesin, which is an expectorant.

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

Children aged 6 to under 12 years should take 30 mL (2 dose cups) every 4 hours.

Is TexaClear Kids safe for children under 4 years?

No, TexaClear Kids should not be used in children under 4 years.

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

You should stop use and ask a doctor if the cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

Are there any contraindications for using TexaClear Kids?

Yes, do not use TexaClear Kids in a child who is taking a prescription monoamine oxidase inhibitor (MOAI) or for 2 weeks after stopping the MAOI drug.

Can TexaClear Kids be used during pregnancy?

The safety of TexaClear Kids during pregnancy has not been established, and there are no specific contraindications mentioned.

What are the storage instructions for TexaClear Kids?

Store TexaClear Kids at room temperature between 20-30°C (68-86°F).

What should I do in case of an overdose?

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

Is TexaClear Kids free from common allergens?

Yes, TexaClear Kids is dye-free, sugar-free, gluten-free, alcohol-free, and acetaminophen-free.

Packaging Info

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

Packaging configurations for Texaclear Kids Daytime Cough and Chest Congestion.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

TexaClear Kids Daytime Cough and Chest Congestion is a liquid formulation designed for children aged 4 and older. Each 8 fl. oz. (237 mL) bottle contains active ingredients including Dextromethorphan HBr, a cough suppressant, and Guaifenesin, an expectorant. The product is characterized by its dye-free, sugar-free, gluten-free, alcohol-free, and acetaminophen-free composition. It is intended to relieve symptoms of chest congestion, thin and loosen mucus, and suppress cough. The product is tamper evident; do not use if the foil seal under the cap is broken or missing. TexaClear Kids is distributed by GM Pharmaceuticals, Inc., located in Fort Worth, TX 76118.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

Temporary relief of the intensity of coughing is also provided.

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

Dosage and Administration

The maximum recommended dosage should not exceed six doses within a 24-hour period. Dosing must be measured exclusively with the dosing cup provided to ensure accuracy.

For children aged 6 years to under 12 years, the recommended dosage is 30 mL, equivalent to 2 dose cups, administered every 4 hours. For children aged 4 years to under 6 years, the appropriate dosage is 15 mL, or 1 dose cup, also given every 4 hours.

It is important to note that this medication is not indicated for use in children under 4 years of age.

Contraindications

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 typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Prior to administration, healthcare professionals should verify whether the child's prescription includes an MAOI by consulting with a doctor or pharmacist.

Warnings and Precautions

It is imperative to adhere strictly to the recommended dosage when administering this product. Exceeding the recommended dosage may lead to adverse effects.

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

Healthcare professionals should exercise caution and consult a physician before use if the child presents with any of the following conditions: persistent or chronic cough, particularly that which is associated with asthma; a cough accompanied by excessive phlegm (mucus); or if the child is on a sodium-restricted diet.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised without delay.

Should the cough persist for more than seven days, recur, or be accompanied by fever, rash, or a persistent headache, it is crucial to discontinue use and consult a healthcare provider. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is crucial not to exceed the recommended dosage, as doing so may lead to serious complications.

Participants are advised to stop use and consult a healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Before administering this medication to children, it is important to seek medical advice if the child has a persistent or chronic cough, such as that which occurs with asthma, a cough that produces excessive phlegm, or if the child is on a sodium-restricted diet.

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

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, certain psychiatric conditions, or Parkinson's disease. It is essential to avoid administering this product to a child who is currently taking an MAOI or has discontinued an MAOI within the past two weeks.

Healthcare professionals should ensure that patients or caregivers are informed about the presence of MAOIs in any prescription medications. If there is uncertainty regarding whether a child's prescription includes an MAOI, it is advisable to consult a physician or pharmacist prior to the administration of this product.

Packaging & NDC

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

Packaging configurations for Texaclear Kids Daytime Cough and Chest Congestion.
Details

Pediatric Use

Pediatric patients should not use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks following the discontinuation of an MAOI. Prior to administration, it is advisable to consult a healthcare professional if the child has a persistent or chronic cough, such as that associated with asthma, a cough accompanied by excessive phlegm, or is on a sodium-restricted diet.

If the cough persists for 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 for pediatric patients are as follows: for children aged 6 years to under 12 years, the dosage is 30 mL (2 dose cups) every 4 hours; for children aged 4 years to under 6 years, the dosage is 15 mL (1 dose cup) every 4 hours. This medication is not recommended for children under 4 years of age.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

The safety of TexaClear Kids Daytime Cough and Chest Congestion during pregnancy has not been established. There are no specific contraindications for its use in pregnant patients. However, the prescribing information does not provide data regarding potential risks to the fetus. Additionally, no dosage modifications for pregnant individuals are specified, and there are no special precautions mentioned regarding its use during pregnancy. Healthcare professionals should weigh the potential benefits against any unknown risks when considering this medication for pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of TexaClear Kids Daytime Cough and Chest Congestion in lactating mothers. Additionally, there is no information available concerning the potential for excretion of the product in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the 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 vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by the severity of the symptoms and the clinical judgment of the healthcare provider. Supportive care and symptomatic treatment may be necessary, and the involvement of poison control experts can provide additional guidance on the appropriate management strategies.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

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 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 patients are uncertain whether their child's prescription includes an MAOI, they should be encouraged to consult with a doctor or pharmacist prior to administering this product.

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 fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Additionally, healthcare providers should recommend that patients consult a doctor before using this product if the child has a persistent or chronic cough, such as that associated with asthma, a cough that produces excessive phlegm (mucus), or if the child is on a sodium-restricted diet.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 20-30°C (68-86°F). Care should be taken to ensure that the product is kept in a suitable container to maintain its integrity. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Texaclear Kids Daytime Cough and Chest Congestion, 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 Texaclear Kids Daytime Cough and Chest Congestion, 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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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.