Counteract

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with a cold. It also provides temporary relief for occasional minor irritation or sore throat.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 5 years and older should dissolve 1 drop slowly in the mouth. This dosage may be repeated every 2 hours as needed. For children under 5 years of age, it is advised to consult a physician before administration.

Contraindications

There are no specific contraindications for this product. However, it is advised to discontinue use and consult a healthcare professional if any of the following conditions occur:

• Cough persists for more than one week, recurs, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition.

• Sore mouth does not show improvement within 7 days.

• Any irritation, pain, or redness persists or worsens.

Warnings and Precautions

If a patient experiences a severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a healthcare professional promptly. These symptoms may indicate a more serious underlying condition that requires immediate attention.

Patients should discontinue use and seek medical advice if any of the following occur: a cough that persists for more than one week, a cough that tends to recur, or a cough accompanied by fever, rash, or a persistent headache. These symptoms may signify a serious condition that necessitates further evaluation. Additionally, if a sore mouth does not show improvement within seven days, or if there is ongoing irritation, pain, or redness that persists or worsens, it is essential to contact a healthcare provider for further assessment and guidance.

Monitoring for these symptoms is crucial to ensure patient safety and to facilitate timely intervention when necessary.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions warrant immediate medical attention, particularly in the case of a severe sore throat that persists for more than 2 days or is accompanied by additional symptoms such as fever, headache, rash, swelling, nausea, or vomiting. In such instances, patients are advised to consult a healthcare professional promptly.

Common adverse reactions include the need to stop use and seek medical advice if a cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious underlying condition. Additionally, if a sore mouth does not show improvement within 7 days, or if irritation, pain, or redness persists or worsens, patients should discontinue use and consult a doctor.

Before using this medication, patients should seek medical advice if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus). These considerations are important to ensure the safe and effective use of the product.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Counteract (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a healthcare professional. For children under 5 years, it is advised to consult a doctor before use.

For pediatric patients aged 5 years and older, the recommended dosage is to dissolve 1 drop slowly in the mouth. This dosage may be repeated every hour as needed or as directed by a healthcare provider.

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 prior to 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 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 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, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the lack of detailed overdosage data necessitates a vigilant approach. Symptoms may vary depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement standard supportive measures, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation.

Additionally, it is recommended to contact a poison control center or consult relevant toxicology resources for guidance on specific management strategies tailored to the situation. Continuous assessment and supportive care are critical in managing any adverse effects that may occur as a result of overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion.

Patients should be instructed to stop use and consult a doctor if their cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious condition. Additionally, if a sore mouth does not improve within 7 days, or if irritation, pain, or redness persists or worsens, patients should seek medical advice.

It is also important for healthcare providers to remind patients to ask a doctor before using this medication if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from moisture and heat to maintain its integrity and efficacy. Proper handling is essential to prevent exposure to conditions that may compromise the product's quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)