Strawberry Cough Drops

Description

TopCare Strawberry Cough Drops are formulated to provide symptomatic relief for coughs. Each package contains 30 cough drops, designed for oral administration. The cough drops are characterized by their strawberry flavor, which enhances palatability. The specific composition and active ingredients are not detailed in the provided information.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with a cold, as well as for the alleviation of occasional minor irritation and sore throat.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Adults and children aged 5 years and older are instructed to allow 2 drops to dissolve slowly in the mouth, one at a time. This process may be repeated every 2 hours as necessary or as directed by a healthcare professional. For children under 5 years of age, it is recommended to consult a doctor prior to administration.

The route of administration is oral, with the method involving the slow dissolution of the drops in the mouth. The frequency of administration can be adjusted based on individual needs, with the option to repeat every 2 hours as required or as advised by a physician.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should discontinue use and consult a healthcare professional if cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition.

Additionally, patients should stop use and seek medical advice if they experience severe sore throat, or if irritation, pain, or redness persists or worsens.

If sore mouth symptoms do not improve within 7 days, medical consultation is also advised.

Warnings and Precautions

Patients should be advised to seek medical attention promptly if they experience a severe sore throat that persists for more than two days, particularly if it is accompanied by fever, headache, rash, swelling, nausea, or vomiting. These symptoms may indicate a serious underlying condition. Additionally, if symptoms of a sore mouth do not show improvement within seven days, it is essential to consult a dentist or physician.

Healthcare professionals should instruct patients to discontinue use and contact their doctor if any of the following occur: a cough that persists for more than seven days, a cough that tends to recur, or a cough accompanied by fever, rash, or a persistent headache, as these may be indicative of a serious condition. Furthermore, patients should be advised to seek medical advice if they experience severe sore throat symptoms or if irritation, pain, or redness lasts or worsens. It is also critical to monitor sore mouth symptoms, as lack of improvement within seven days warrants a consultation with a healthcare provider.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions warrant immediate medical attention, particularly in the case of severe sore throat. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, patients should consult a doctor promptly, as these symptoms may indicate a serious condition.

Common adverse reactions include persistent cough, which should prompt patients to stop use and seek medical advice if it lasts for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These symptoms could also signify a serious underlying condition. Additionally, if a sore throat is severe or if irritation, pain, or redness lasts or worsens, patients are advised to discontinue use and consult a healthcare professional.

Patients should also be aware that if a sore mouth does not improve within 7 days, they should seek medical advice. Prior to using this product, individuals with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should consult a doctor. Furthermore, those experiencing a cough accompanied by excessive phlegm (mucus) are also encouraged to seek medical guidance before use.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 5 years of age should consult a healthcare professional before use. For children aged 5 years and older, the recommended dosage is 2 drops to be dissolved slowly in the mouth, one at a time. This dosage may be repeated every 2 hours as necessary or as directed by a healthcare provider.

Geriatric Use

There is no specific information available 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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 evaluated 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 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 clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

Overdosage

In the context of overdosage, it is important to note that no specific information regarding overdosage has been provided in the available documentation. Healthcare professionals are advised to exercise caution and consider the potential implications of an overdose based on the pharmacological profile of the medication in question.

In the absence of detailed overdosage data, it is recommended that healthcare providers monitor patients closely for any unusual symptoms or adverse effects that may arise. Should an overdose be suspected, standard emergency protocols should be initiated, including supportive care and symptomatic treatment as necessary.

Healthcare professionals are encouraged to consult relevant clinical guidelines and toxicology resources for further management strategies in cases of suspected overdosage.

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

Adverse events have been reported voluntarily and through surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events by calling 1-888-423-0139. This information contributes to the ongoing monitoring of the product's safety profile.

Patient Counseling

Healthcare providers should advise patients to keep the 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 7 days, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious condition.

Additionally, patients should be informed to discontinue use and seek medical advice if they experience a severe sore throat, or if irritation, pain, or redness lasts or worsens. It is important to advise patients to stop use and consult a doctor if a sore mouth does not improve within 7 days.

Healthcare providers should also recommend that patients ask a doctor before using the medication if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema. Furthermore, patients should be encouraged to consult a doctor if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. Currently, there are no specified storage or handling conditions provided. It is recommended that healthcare professionals refer to the product's labeling for any additional information regarding supply and storage requirements.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)