Signature Care Cherry Cough Drops

Description

Signature Care Cherry Cough Drops are formulated to provide symptomatic relief for coughs. Each drop is designed for oral administration and is presented in a cherry flavor. The product is packaged in a container containing 200 cough drops, ensuring a sufficient supply for extended use.

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 5 years and older, the recommended dosage is to dissolve 1 lozenge slowly in the mouth. This may be repeated every 2 hours as needed or as directed by a healthcare professional.

For children under 5 years of age, it is advised to consult a doctor before administration.

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, if a patient experiences severe sore throat, or if irritation, pain, or redness lasts or worsens, they should seek medical advice. Furthermore, if a sore mouth does not improve within 7 days, it is advised to stop use and consult a healthcare provider.

Warnings and Precautions

Patients should be closely monitored for the following symptoms and conditions, as they may indicate the need for medical intervention.

Sore Throat Warning Healthcare professionals should advise patients to seek prompt medical attention if they experience a severe sore throat that persists for more than 2 days, especially if it is accompanied by fever, headache, rash, swelling, nausea, or vomiting. These symptoms may indicate a serious underlying condition. Additionally, if symptoms related to a sore mouth do not show improvement within 7 days, patients should be referred to a dentist or physician for further evaluation.

Cough Monitoring Patients should be instructed to discontinue use and consult a healthcare provider if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These signs may suggest a serious health issue that requires further investigation.

Sore Throat and Mouth Symptoms In cases where a sore throat is severe, or if irritation, pain, or redness persists or worsens, patients should be advised to stop use and seek medical advice. Furthermore, if symptoms related to a sore mouth do not improve within 7 days, a consultation with a healthcare professional is recommended to rule out any serious conditions.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include severe sore throat, which, if it persists for more than 2 days or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, necessitates prompt consultation with a healthcare provider. Additionally, if symptoms of a sore mouth do not improve within 7 days, patients are advised to seek medical attention from a dentist or doctor, as these symptoms may indicate a serious condition.

Common adverse reactions warranting attention include a persistent cough that lasts more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. Such symptoms may also suggest the presence of a serious underlying condition. Patients should discontinue use and consult a healthcare professional if they experience severe sore throat, or if irritation, pain, or redness lasts or worsens.

Furthermore, patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should seek medical advice before using this medication. Cough accompanied by excessive phlegm (mucus) also requires consultation with a healthcare provider prior to use.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Signature Care Cherry 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 to dissolve 1 lozenge slowly in the mouth, with the option to repeat every 2 hours as needed or as directed by a healthcare provider.

Geriatric Use

There is no specific information 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. It is advisable to monitor these patients closely for any 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 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 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 in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the lack of documented information.

Management Procedures In the absence of specific antidotes or treatment protocols, healthcare professionals should consider standard overdosage management practices, including the possibility of activated charcoal administration if the patient presents within a suitable timeframe. Consultation with a poison control center may also be beneficial for guidance on further management strategies.

Overall, due diligence and a thorough evaluation of the patient's condition are paramount in managing any suspected overdosage effectively.

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 to the designated contact number, 1-800-245-2898, available Monday through Friday from 9 AM to 4 PM EST. This reporting mechanism is in place to ensure 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 discontinue 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 seek medical advice if they experience a severe sore throat or if irritation, pain, or redness lasts or worsens. If a sore mouth does not show improvement within 7 days, patients are also encouraged to contact their healthcare provider.

Before initiating treatment, healthcare providers should recommend that patients consult a doctor if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema. Furthermore, patients should be advised to seek medical guidance if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in a secure bag, and it is imperative that the bag remains intact. Healthcare professionals should not use the product if the bag is torn or open, as this may compromise the integrity and safety of the contents.

For optimal storage, the product should be kept in a controlled environment, away from direct sunlight and moisture. It is essential to adhere to the recommended storage conditions to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)