Physicians Care Cough and Sore Throat

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with colds or inhaled irritants. Additionally, it provides temporary relief from occasional minor irritation and sore throat.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to allow one lozenge to dissolve slowly in the mouth. This may be repeated every 2 hours as necessary or as directed by a healthcare professional.

It is important to note that this medication is not recommended for children under 12 years of age.

The route of administration is oral, utilizing the lozenge form, which should be allowed to dissolve slowly in the mouth to ensure optimal efficacy.

Contraindications

There are no specific contraindications listed for this product. However, healthcare professionals should advise patients to discontinue use and consult a physician under the following circumstances:

• If cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious condition.

• If sore mouth does not improve within 7 days.

• If 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, nausea, or vomiting, it is imperative to consult a healthcare professional promptly, as these symptoms may indicate a serious underlying condition.

Healthcare providers should advise patients to seek medical guidance prior to use if they have a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients with a cough that is accompanied by excessive phlegm (mucus) should also consult a doctor before initiating treatment.

Patients are instructed to discontinue use and contact their healthcare provider if the cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, as these may be indicative of a serious condition. Furthermore, if a sore mouth does not show improvement within seven days, or if irritation, pain, or redness persists or worsens, medical advice should be sought.

No specific instructions for obtaining emergency medical help are provided; however, healthcare professionals should remain vigilant and assess the need for urgent care based on the clinical presentation of the patient.

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 cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting. These symptoms may indicate a serious underlying condition.

Common adverse reactions include persistent cough that lasts more than one week, especially if it tends to recur or is accompanied by fever, rash, or persistent headache. Such symptoms should prompt patients to consult a healthcare professional, as they may signify a serious condition. Additionally, if a sore mouth does not show improvement within seven days, or if irritation, pain, or redness persists or worsens, patients are advised to seek medical advice.

Patients with a history of persistent or chronic cough due to smoking, asthma, or emphysema should consult a doctor before using this medication. Furthermore, those experiencing a cough accompanied by excessive phlegm (mucus) should also seek medical guidance prior to use.

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 Physicians Care Cough and Sore Throat (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. Safety and efficacy have not been established in this age group, and therefore, it is contraindicated for use in children under 12.

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 potential adverse effects or changes in efficacy, 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 currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be warranted in these patients to ensure safety and efficacy.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be warranted to guide management decisions.

It is crucial to document all findings and interventions in the patient's medical record and to report any adverse events to the appropriate regulatory authorities as per local guidelines.

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 question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of the reach of children to prevent accidental ingestion.

Patients should be instructed to stop using the medication and consult a doctor if any of the following occur: if a cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these 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 encourage patients to ask a doctor before using this medication if they have a persistent or chronic cough associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus). This ensures that patients receive appropriate guidance tailored to their specific health conditions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 59ºF to 86ºF (15ºC to 30ºC). Care must be taken to protect the product from moisture and heat to ensure its integrity and efficacy. Proper storage conditions are essential for maintaining the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)