Topco

Description

No description information is available.

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 aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

Additionally, this drug temporarily relieves the intensity of coughing and the impulse to cough, which can assist children in achieving restful sleep.

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

Dosage and Administration

The maximum recommended dosage is six doses within a 24-hour period. Dosing should be measured exclusively with the dosing cup provided with the product; the use of this cup with other products is not advised.

For children aged 6 years to under 12 years, the recommended dose is 5 mL to 10 mL administered every 4 hours as needed, or as directed by a healthcare professional. For children aged 4 years to under 6 years, the appropriate dose is 2.5 mL to 5 mL every 4 hours, also as needed or as directed by a healthcare professional.

This product is not recommended 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 within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a child's prescription medication, consultation with a healthcare professional is advised prior to administration of this product. Additionally, it is essential to adhere to the recommended dosage and not exceed the directed amount while using this product.

Warnings and Precautions

The use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken an MAOI within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. Healthcare professionals should advise caregivers to consult a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

Prior to administration, it is essential to consult a healthcare provider if the child presents with a cough accompanied by excessive phlegm (mucus) or if the cough is persistent or chronic, as seen in conditions such as asthma. These symptoms may indicate underlying health issues that require further evaluation.

If the child's cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, caregivers should discontinue use and seek medical advice immediately. These symptoms may signify a serious condition that necessitates prompt attention.

To ensure safety, this product must be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is critical to note that the medication is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks following the discontinuation of such a drug, which is commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease.

Patients are advised to discontinue use and consult a healthcare professional 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.

Before using this medication, it is recommended that patients consult a doctor if the child has a cough that produces excessive phlegm (mucus) or if the cough is persistent or chronic, such as that which occurs with asthma.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Drug Interactions

The use of this medication is contraindicated in pediatric patients who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. Co-administration may result in serious interactions that could pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified for this medication. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the stated contraindication.

Packaging & NDC

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

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 presents with a cough accompanied by excessive phlegm or a persistent cough, such as that associated with asthma.

For dosing, children aged 6 years to under 12 years may receive 5 mL to 10 mL every 4 hours. For those aged 4 years to under 6 years, the recommended dose is 2.5 mL to 5 mL 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. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. It is advisable to monitor these patients closely for any adverse effects and to consider potential dose adjustments based on individual clinical circumstances.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, there are no established safety concerns, dosage modifications, or special precautions outlined for pregnant patients. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and weigh the potential risks and benefits. It is advisable to monitor for any adverse fetal outcomes in the absence of comprehensive data.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert 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 data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center without delay. The national helpline for poison control can be reached at 1-800-222-1222.

Prompt intervention is crucial in managing overdose situations to mitigate potential adverse effects. It is essential for healthcare providers to assess the patient's condition and initiate appropriate treatment protocols based on the severity of the overdose and the specific substance involved.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as rash, pruritus, and urticaria. Additionally, gastrointestinal disturbances have been noted, including nausea and vomiting. Central nervous system effects, specifically dizziness and drowsiness, have also been reported.

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 overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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. Patients should be encouraged to consult with a doctor or pharmacist if they are uncertain whether their child's prescription includes an MAOI.

Patients should be instructed to discontinue use and consult a doctor if the cough persists for more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage. Additionally, healthcare providers should advise patients to seek medical advice before use if the child has a cough that produces excessive phlegm (mucus) or if the cough is persistent or chronic, such as that associated with asthma.

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, ensuring that it is not exposed to refrigeration. Proper handling should be observed to maintain the integrity of the product throughout its shelf life.

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 Topco, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)