Sugar Free Original Swiss Herb Cough Suppressant Throat Drops

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with a cold or inhaled irritants. Additionally, it provides temporary relief from occasional minor irritation and pain due to sore throat or sore mouth.

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

Dosage and Administration

Adults and children aged 6 years and older are instructed to dissolve 2 drops (one at a time) slowly in the mouth. This process may be repeated every 2 hours as needed or as directed by a healthcare professional. For children under 6 years of age, it is recommended to consult a doctor before administration.

Contraindications

There are no specific contraindications identified 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 symptoms do 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 or followed by symptoms such as fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a healthcare professional promptly, as these may indicate a serious underlying condition.

This product is contraindicated for use in children under 6 years of age unless specifically directed by a physician.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the following conditions occur: a cough that persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may suggest a serious health issue. Additionally, if a sore mouth does not show improvement within seven days, or if irritation, pain, or redness persists or worsens, medical consultation is recommended.

Monitoring for these symptoms is essential to ensure patient safety and to facilitate timely intervention if necessary.

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, warrants prompt consultation with a healthcare provider. Additionally, patients should be advised not to use this medication in children under 6 years of age unless directed by a doctor.

Common adverse reactions necessitating discontinuation of use and consultation with a healthcare provider include a cough that persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition. Patients should also seek medical advice if a sore mouth does not improve within 7 days or if irritation, pain, or redness persists or worsens.

Before using this medication, patients should consult a healthcare provider if they have a persistent chronic cough, such as that associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Sugar Free Original Swiss Herb Cough Suppressant Throat Drops (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should not use this medication unless directed by a healthcare professional. For pediatric patients aged 6 years and older, the recommended dosage is to dissolve 2 drops (one at a time) slowly in the mouth, with the option to repeat every 2 hours as needed or as directed by a doctor. For children under 6 years, it is advised to consult a doctor before use.

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.

Pregnancy

There is no specific information regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there are no data on the excretion of this medication in human breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the lack of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, the following management procedures should be considered:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement appropriate measures in the event of an overdose, even in the absence of specific guidance.

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

No postmarketing experience details are available in the insert text.

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 using the medication and consult a doctor if their cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious condition. Additionally, if a sore mouth does not improve within seven 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 their doctor before using the medication if they have a persistent chronic cough, such as that which occurs with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus). This ensures that patients receive appropriate guidance based on their individual health conditions.

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 dry place to maintain its integrity and effectiveness. Proper storage conditions are crucial to ensure the product remains stable and safe for use.

Additional Clinical Information

The product is administered orally. Clinicians should inform patients that the formulation contains phenylalanine at a concentration of 1 mg per drop, which is particularly relevant for phenylketonurics. Patients should be cautioned that excessive use may lead to a laxative effect. Additionally, the product may be beneficial for diabetic patients, but this should be undertaken only under the guidance of a healthcare professional.

Drug Information (PDF)

This file contains official product information for Sugar Free Original Swiss Herb Cough Suppressant Throat Drops, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)