Sugar Free Cough Drops Black Cherry

Description

The product is a tablet formulation containing 500 mg of Acetaminophen as the active ingredient. Each tablet is characterized by a white, round, and scored appearance. Inactive ingredients include corn starch, hypromellose, microcrystalline cellulose, povidone, and stearic acid. The SPL code for this product is 34089-3.

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 associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are instructed to dissolve 1 drop slowly in the mouth. This may be repeated every 2 hours as needed or as directed by a healthcare professional.

The use of this medication is not recommended for children under 12 years of age.

Contraindications

Use is contraindicated in patients who experience sore mouth symptoms that do not improve within 7 days, or if irritation, pain, or redness persists or worsens. In such cases, it is advised to discontinue use and consult a healthcare professional.

Warnings and Precautions

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, and vomiting, may indicate a serious condition. In such cases, it is imperative to consult a healthcare professional promptly. Additionally, this product should not be used for more than 2 days, and it is contraindicated for children under 12 years of age.

Patients are advised to discontinue use and seek medical advice if symptoms of a sore mouth do not show improvement within 7 days. Furthermore, if any irritation, pain, or redness persists or worsens during treatment, it is essential to stop taking the product and contact a healthcare provider for further evaluation.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, and vomiting. Such symptoms may indicate a serious condition, and patients are advised to consult a doctor promptly. It is important to note that the product should not be used for more than 2 days, and it is contraindicated for children under 12 years of age.

Common adverse reactions necessitate immediate cessation of use and consultation with a healthcare professional if sore mouth symptoms do not improve within 7 days, or if irritation, pain, or redness persists or worsens.

Before using this product, patients should seek medical advice if they have a severe sore throat that is accompanied by difficulty in breathing or lasts longer than 2 days. Additionally, patients should consult a doctor if they experience a sore throat along with fever, headache, rash, swelling, nausea, or vomiting, as these symptoms may indicate a more serious underlying condition.

Drug Interactions

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

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For patients aged 12 years and older, the recommended dosage is to dissolve 1 drop slowly in the mouth, which may be repeated every 2 hours as needed or as directed by a healthcare professional. Caution is advised when considering the use of this medication in pediatric populations, as safety and efficacy have not been established in children under 12 years.

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. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available 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 advisable in this patient population.

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 event of an accidental overdose, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay.

Prompt intervention is crucial in managing potential overdose situations, as timely medical help can significantly mitigate risks and complications associated with excessive intake. It is essential for healthcare providers to be aware of the signs and symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information.

Management of an overdose should be guided by clinical judgment and may involve supportive care, monitoring of vital signs, and symptomatic treatment as necessary. The healthcare provider should ensure that the patient receives appropriate evaluation and treatment based on the severity of the overdose and the specific circumstances involved.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has included the collection of voluntary reports and data from surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events or concerns related to the use of the product. For inquiries or to report an adverse event, individuals may contact the designated helpline at 1-833-552-1767.

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 symptoms of a sore mouth do not improve within 7 days, or if they experience any irritation, pain, or redness that persists or worsens.

Additionally, healthcare providers should encourage patients to seek medical advice before using this medication if they have a severe throat condition that is accompanied by difficulty in breathing or lasts more than 2 days. Patients should also be advised to consult a doctor if they experience a sore throat along with fever, headache, rash, swelling, nausea, or vomiting.

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 in a cool and dry place to maintain its integrity and effectiveness. Proper storage conditions are crucial to ensure the product remains within its specified quality parameters.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)