Green Guard Cough Drop Relief

Description

No description information is available.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with colds or inhaled irritants. Additionally, it provides temporary relief from 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 allow 1 drop to dissolve slowly in the mouth. This dosage may be repeated every 2 hours as necessary or as directed by a healthcare professional. For children under 12 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 1 drop in the mouth. It is imperative that the dosage does not exceed the directed amount.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if any of the following conditions occur:

• Cough persists for more than one week, recurs, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition.

• Sore mouth does not show improvement within 7 days.

• Any 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 by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly, as these symptoms may indicate a serious underlying condition.

Healthcare providers should advise patients to seek medical guidance prior to use if they have a persistent or chronic cough, particularly in cases associated with smoking, asthma, or emphysema. Additionally, patients with a cough that is accompanied by excessive phlegm (mucus) should also consult a doctor before initiating treatment.

Patients are instructed to discontinue use and contact their healthcare provider if the cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, as these may be indicative of a serious health issue. Furthermore, if a sore mouth does not show improvement within seven days, or if any irritation, pain, or redness persists or worsens, medical advice should be sought immediately.

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 warrant immediate medical attention, particularly in cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting. These symptoms may indicate a serious underlying condition.

Additionally, patients should discontinue use and consult a healthcare professional if they experience a cough that persists for more than 1 week, recurs, or is accompanied by fever, rash, or a persistent headache, as these may also be signs of a serious condition. A sore mouth that does not improve within 7 days, as well as any irritation, pain, or redness that persists or worsens, should prompt patients to seek medical advice.

Monitoring for these adverse reactions is essential to ensure patient safety and effective management of symptoms.

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 Green Guard Cough Drop Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 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 relation to the use of this medication. Consequently, there are no established 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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, alterations in consciousness, cardiovascular instability, and gastrointestinal disturbances.

Management of an overdose should be tailored to the individual patient and may involve supportive care, including monitoring vital signs and providing symptomatic treatment as necessary. In severe cases, specific interventions such as activated charcoal may be considered if the patient presents within a suitable timeframe post-ingestion.

It is crucial for healthcare professionals to consult local poison control guidelines and the product's prescribing information for further recommendations on the management of overdose situations.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

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 any of the following occur: if a cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition; if a sore mouth does not improve within 7 days; or if irritation, pain, or redness persists or worsens.

Additionally, healthcare providers should recommend that patients seek medical advice before using the medication if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or 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 upon request. It is essential to store the product at temperatures ranging from 59ºF to 86ºF (15ºC to 30ºC). Care should be taken to protect the product from moisture and heat to ensure its integrity and efficacy. Proper storage conditions are crucial for maintaining the quality of the product throughout its shelf life.

Additional Clinical Information

For adults and children aged 12 years and older, the recommended administration is to allow 1 drop to dissolve slowly in the mouth, with the option to repeat every 2 hours as necessary or as directed by a healthcare professional. For children under 12 years, it is advised to consult a doctor before administration.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)