Cough Drops

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 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 accompanied by high fever, headache, nausea, and vomiting may indicate a serious condition. Healthcare professionals are advised to consult a physician promptly in such cases. It is important to note that this product should not be used for more than 2 days and is contraindicated for children under 12 years of age.

If symptoms of a sore mouth do not improve within 7 days, or if irritation, pain, or redness persists or worsens, the patient should discontinue use and seek medical advice.

No specific instructions for emergency medical assistance are provided; however, healthcare professionals should remain vigilant for any signs of severe adverse reactions that may require immediate intervention.

Currently, there are no general precautions or laboratory tests specified for monitoring the safe use of this product.

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.

Patients should also seek medical advice prior to use if they have a severe sore throat that is accompanied by difficulty in breathing or lasts longer than 2 days. Additionally, those experiencing a sore throat with fever, headache, rash, swelling, nausea, or vomiting should consult a doctor before using the product.

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 Cough Drops (simply sugar free honey lemon). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents 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.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

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 information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding hepatic impairment, including dosage adjustments, special monitoring requirements, or precautions for patients with compromised liver function. Therefore, no specific recommendations can be made for the use of this medication in patients with hepatic impairment.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt action is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs.

Allergic reactions have been noted, including manifestations such as rash, itching, and swelling. Gastrointestinal disturbances, specifically nausea and diarrhea, have also been reported. Respiratory issues, including wheezing and difficulty breathing, were observed among patients. Neurological effects, such as dizziness and headache, have been documented as well. Additionally, skin reactions, including redness and irritation, were reported. Other unspecified adverse events have been noted by patients, contributing to the overall safety profile of the product.

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 the 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 Cough Drops, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)