Gems

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of cough due to a cold and for the alleviation of occasional minor irritation or sore throat.

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

Dosage and Administration

Adults and children aged 5 years and older are instructed to dissolve 1 drop slowly in the mouth. This process may be repeated every 2 hours as needed, ensuring that the total dosage does not exceed the directed amount. For children under 5 years of age, it is recommended to consult a physician before administration.

Contraindications

There are no specific contraindications listed for this product. However, healthcare professionals should advise patients to discontinue use and consult a physician under the following circumstances:

• If sore mouth symptoms do not improve within 7 days.

• If cough persists for more than 1 week, recurs, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious condition.

• If irritation, pain, or redness persists or worsens.

Warnings and Precautions

Severe or persistent sore throat, particularly when accompanied by high fever, headache, rash, swelling, nausea, or vomiting, may indicate a serious condition. In such cases, it is imperative to consult a healthcare professional promptly. Patients are advised not to use the medication for more than two days unless directed by a physician.

Healthcare professionals should exercise caution and recommend that patients seek medical advice prior to use if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema. Additionally, patients with a cough accompanied by excessive phlegm (mucus) should also consult a doctor before using the medication.

Patients should discontinue use and consult a healthcare provider if the following conditions occur: sore mouth does not improve within seven days; cough persists for more than one week, recurs, or is accompanied by fever, rash, or persistent headache, as these may be indicative of a serious underlying condition; or if irritation, pain, or redness persists or worsens.

Emergency medical assistance should be sought if any severe reactions or symptoms arise, although specific instructions for such situations are not provided in the current guidelines.

Side Effects

Patients may experience a range of adverse reactions, some of which may require immediate medical attention.

Severe or persistent sore throat, particularly when accompanied by high fever, headache, rash, swelling, nausea, or vomiting, may indicate a serious condition. Patients are advised to consult a doctor promptly if these symptoms occur. Additionally, it is recommended that the product not be used for more than 2 days unless directed by a healthcare professional.

Patients should also discontinue use and seek medical advice if the sore mouth does not improve within 7 days. A cough that persists for more than one week, recurs, or is accompanied by fever, rash, or persistent headache may also signal a serious underlying condition. Furthermore, if irritation, pain, or redness persists or worsens, patients should stop use and consult a doctor.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 Gems (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 drop slowly in the mouth, with the option to repeat every 2 hours as needed.

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 elderly patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population. Consideration of individual patient factors, including comorbidities and concurrent medications, is essential in managing treatment effectively.

Pregnancy

There is no specific information regarding the use of this medication 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. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be advised to discuss their pregnancy status and any plans for pregnancy with their healthcare provider prior to initiating treatment.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised when considering the use of this product during lactation.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available 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.

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 indicate an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. Healthcare professionals should also consider contacting a poison control center for additional guidance on the management of overdose cases.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective treatment and follow-up care. Continuous monitoring and reassessment of the patient’s condition are recommended until they are stabilized.

Nonclinical Toxicology

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

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this 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 sore mouth does not improve within 7 days. Additionally, if a cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or a persistent headache, patients should seek medical advice, as these symptoms may indicate a serious condition. It is also important to inform patients to discontinue use and contact a healthcare professional if they experience any irritation, pain, or redness that persists or worsens.

Before initiating treatment, healthcare providers should encourage patients to discuss their medical history, particularly if they have a persistent or chronic cough associated with smoking, asthma, or emphysema. Patients should also be advised to consult a doctor if their cough is accompanied by excessive phlegm (mucus) prior to using the medication.

Storage and Handling

The product is available in various package configurations, with specific NDC numbers assigned for identification. Storage and handling instructions are not explicitly provided; therefore, standard practices for pharmaceutical products should be followed. It is advisable to store the product in a controlled environment, ensuring that it is kept at appropriate temperatures to maintain its integrity. Containers should be kept sealed and protected from light and moisture to prevent degradation. Special handling requirements are not specified, but general precautions should be taken to ensure the product's quality and safety during storage and transportation.

Additional Clinical Information

The medication is administered orally. For adults and children aged 5 years and older, the recommended dosage is to dissolve 1 drop slowly in the mouth, with the option to repeat every 2 hours as needed. For children under 5 years of age, it is advised to consult a doctor for appropriate guidance.

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

View product document (PDF)