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Texaclear Kids Allergy
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- Active ingredients
- Chlophedianol Hydrochloride 12.5 mg/30 mL
- Pyrilamine Maleate 25 mg/30 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 2016
- Label revision date
- October 15, 2025
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredients
- Chlophedianol Hydrochloride 12.5 mg/30 mL
- Pyrilamine Maleate 25 mg/30 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 2016
- Label revision date
- October 15, 2025
- Manufacturer
- GM Pharmaceuticals, Inc.
- Registration number
- M12
- NDC root
- 58809-925
- Drug Information (PDF)
- Prescribing information, PDF file
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 Allergy + Cough is a medication designed to help relieve symptoms associated with the common cold, hay fever (allergic rhinitis), and other upper respiratory allergies. It contains two active ingredients: chlophedianol HCl, which acts as a cough suppressant, and pyrilamine maleate, an antihistamine that helps alleviate symptoms such as an itchy nose or throat, sneezing, itchy and watery eyes, a runny nose, and cough due to minor throat and bronchial irritation.
This product is suitable for children aged 6 and older and is formulated to be gluten-free, dye-free, sugar-free, and alcohol-free, making it a gentle option for young ones experiencing allergy or cold symptoms.
Uses
You can use this medication to temporarily relieve symptoms caused by the common cold, hay fever (which is an allergic reaction affecting the nose), or other upper respiratory allergies. If you're experiencing an itchy nose or throat, sneezing, itchy and watery eyes, a runny nose, or a cough due to minor irritation in your throat and bronchial tubes, this medication may help alleviate those discomforts.
It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication.
Dosage and Administration
When using this medication, it's important to follow the correct dosage to ensure safety and effectiveness. For adults and children aged 12 years and older, you should take 60 mL (which is equivalent to 2 dose cups) every 6 to 8 hours. If you're giving this medication to children between the ages of 6 and 12, the dosage is 30 mL (or 1 dose cup) every 6 to 8 hours.
Make sure not to exceed 4 doses in a 24-hour period. Always use the enclosed dose cup to measure your medication accurately, and keep it with the product for convenience. Please note that this medication is not recommended for children under 6 years of age.
What to Avoid
It's important to follow the instructions provided with your medication carefully. You should not use more than the directed amount, as exceeding this can lead to unwanted effects. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always prioritize your health and safety by adhering to the recommended guidelines. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider for guidance.
Side Effects
Before using this medication, it's important to consult your doctor if you have a chronic cough (like those from smoking, asthma, or emphysema), glaucoma, difficulty urinating due to an enlarged prostate, a cough with excessive mucus, or any breathing issues such as emphysema or chronic bronchitis.
You should stop using the medication and contact your doctor if you experience nervousness, dizziness, or sleeplessness. Additionally, if your symptoms do not improve within 7 days, worsen, or are accompanied by a fever, rash, or persistent headache, it's crucial to seek medical advice. A new symptom may also warrant a discussion with your healthcare provider. If you are taking sedatives or tranquilizers, please consult your doctor or pharmacist before use.
Warnings and Precautions
Before using this medication, it's important to consult your doctor if you have certain health conditions. These include a chronic cough (like those from smoking, asthma, or emphysema), glaucoma, difficulty urinating due to an enlarged prostate, a cough with excessive mucus, or any breathing issues such as emphysema or chronic bronchitis.
You should stop using the medication and contact your doctor if you experience nervousness, dizziness, or trouble sleeping. Additionally, if your symptoms do not improve within 7 days, come back after improving, or are accompanied by a fever, rash, or persistent headache, it's crucial to seek medical advice. A persistent cough could indicate a more serious health issue. In the event of an overdose, seek medical help or contact a Poison Control Center immediately.
Overdose
It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.
In case of an overdose, contact your local emergency services or go to the nearest hospital right away. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.
Pregnancy Use
If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking professional advice.
Lactation Use
If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.
Pediatric Use
When it comes to using this medication for children, it's important to follow specific guidelines. For children aged 6 to under 12 years, the recommended dose is 30 mL (which is one dose cup) every 6 to 8 hours. However, if your child is under 6 years old, you should not use this medication at all.
Be aware that some children may experience excitability (increased energy or restlessness) when taking this medication, particularly those aged 6 and older. Always monitor your child for any unusual reactions and consult your healthcare provider if you have any concerns.
Geriatric Use
While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions.
Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to help manage your overall care effectively.
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 liver function tests (which check how well your liver is working) to ensure your safety while using any medication.
Drug Interactions
It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.
Storage and Handling
To ensure the best performance and safety of your product, store it at room temperature, specifically between 68-86°F (20-30°C). This temperature range helps maintain the integrity of the device.
When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.
Additional Information
No further information is available.
FAQ
What is TexaClear® Kids Allergy + Cough used for?
TexaClear® Kids Allergy + Cough temporarily relieves symptoms due to the common cold, hay fever (allergic rhinitis), or other upper respiratory allergies, including itchy nose or throat, sneezing, itchy watery eyes, runny nose, and cough due to minor throat and bronchial irritation.
What are the active ingredients in TexaClear® Kids Allergy + Cough?
The active ingredients are Chlophedianol HCl, which is a cough suppressant, and Pyrilamine Maleate, which is an antihistamine.
What is the recommended dosage for children aged 6 to under 12 years?
Children aged 6 to under 12 years should take 30 mL (1 dose cup) every 6 to 8 hours.
Can children under 6 years use TexaClear® Kids Allergy + Cough?
No, TexaClear® Kids Allergy + Cough should not be used in children under 6 years of age.
What should I do if I experience nervousness or dizziness while using this medication?
If you experience nervousness, dizziness, or sleeplessness, you should stop using the medication and ask a doctor.
Is TexaClear® Kids Allergy + Cough safe for pregnant or breastfeeding women?
If you are pregnant or breastfeeding, you should ask a health professional before using TexaClear® Kids Allergy + Cough.
What precautions should I take before using TexaClear® Kids Allergy + Cough?
You should ask a doctor before use if you have a chronic cough, glaucoma, difficulty urinating, or breathing problems such as emphysema or chronic bronchitis.
How should TexaClear® Kids Allergy + Cough be stored?
Store TexaClear® Kids Allergy + Cough at room temperature between 68-86°F (20-30°C).
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 Allergy + Cough gluten-free?
Yes, TexaClear® Kids Allergy + Cough is gluten-free, dye-free, sugar-free, alcohol-free, and acetaminophen-free.
Packaging Info
Below are the non-prescription pack sizes of Texaclear Kids Allergy (chlophedianol hcl pyrilamine maleate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Liquid |
| ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Drug Information (PDF)
This file contains official product information for Texaclear Kids Allergy, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
No description information is available for the drug.
Uses and Indications
This drug is indicated for the temporary relief of symptoms associated with the common cold, hay fever (allergic rhinitis), or other upper respiratory allergies. The symptoms alleviated by this medication include itchy nose or throat, sneezing, itchy and watery eyes, runny nose, and cough due to minor throat and bronchial irritation.
There are no teratogenic or nonteratogenic effects associated with this drug.
Dosage and Administration
Adults and children aged 12 years and older are advised to administer 60 mL (equivalent to 2 dose cups) every 6 to 8 hours, ensuring that the total does not exceed 4 doses within a 24-hour period. For children aged 6 to under 12 years, the recommended dosage is 30 mL (1 dose cup) every 6 to 8 hours, also adhering to the maximum limit of 4 doses in a 24-hour timeframe.
It is essential to utilize the enclosed dose cup for accurate measurement and to keep it with the product for convenience. The product is not recommended for use in children under 6 years of age.
Contraindications
There are no specific contraindications listed for this product. However, it is essential to adhere to the recommended dosage guidelines. Use of the product in excess of the directed amount is not advised.
Warnings and Precautions
Healthcare professionals should exercise caution when recommending this medication. Prior to use, it is imperative to consult a physician if the patient presents with any of the following conditions: a chronic cough, which may be associated with smoking, asthma, or emphysema; glaucoma; difficulty urinating due to prostate gland enlargement; a cough accompanied by excessive phlegm; or any breathing issues such as emphysema or chronic bronchitis.
Patients should be advised to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not show improvement within 7 days, recur, or are accompanied by fever, rash, or a persistent headache, medical consultation is warranted. A persistent cough may indicate a more serious underlying condition, necessitating further evaluation. The emergence of new symptoms should also prompt a discussion with a healthcare provider.
In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.
Side Effects
Patients should be aware of several important warnings and potential adverse reactions associated with the use of this medication. It is advised that individuals consult a healthcare professional prior to use if they have a cough that is chronic, such as that which occurs with smoking, asthma, or emphysema. Additionally, those with glaucoma, difficulty in urination due to prostate gland enlargement, cough accompanied by excessive phlegm, or breathing problems such as emphysema or chronic bronchitis should seek medical advice before starting treatment.
Patients are instructed to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Furthermore, if symptoms do not improve within 7 days, recur, or are accompanied by fever, rash, or persistent headache, medical attention should be sought. A persistent cough may indicate a serious underlying condition, warranting further evaluation. The emergence of new symptoms also necessitates consultation with a healthcare professional.
Individuals taking sedatives or tranquilizers should ask a doctor or pharmacist for guidance before using this medication to avoid potential interactions.
Drug Interactions
There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.
Packaging & NDC
Below are the non-prescription pack sizes of Texaclear Kids Allergy (chlophedianol hcl pyrilamine maleate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Liquid |
| ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric patients aged 6 to under 12 years may receive a dosage of 30 mL (1 dose cup) every 6 to 8 hours. For children under 6 years of age, the use of this medication is not recommended.
Healthcare professionals should be aware that excitability may occur, particularly in pediatric patients. Therefore, monitoring for this side effect is advised in children receiving treatment.
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
Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.
Lactation
Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.
Renal Impairment
Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.
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 this 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 arise from an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.
Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. Healthcare professionals should also consider contacting a poison control center for additional guidance on the management of overdose cases.
In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an 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
Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: nervousness, dizziness, sleeplessness, and excitability, particularly noted in children.
Patient Counseling
Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.
Patients should be informed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days, recur, or are accompanied by a fever, rash, or persistent headache, they should seek medical advice. A persistent cough may indicate a serious condition, warranting further evaluation.
When using this product, patients must be cautioned not to exceed the recommended dosage. They should be made aware that marked drowsiness may occur and that the use of alcohol, sedatives, or tranquilizers can enhance this drowsiness. Patients should exercise caution when driving a motor vehicle or operating machinery due to the potential for drowsiness. It is also important to inform patients that excitability may occur, particularly in children.
Before using this product, patients should be encouraged to consult with a doctor or pharmacist if they are currently taking sedatives or tranquilizers to ensure safe use.
Storage and Handling
The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a temperature range of 68-86°F (20-30°C). Proper storage conditions are crucial to ensure 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 Texaclear Kids Allergy, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.