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. Healthcare professionals should advise patients to consult a doctor promptly in such cases. It is also important to note that the product should not be used for more than 2 days unless directed by a healthcare provider.

Before recommending this product, healthcare professionals should inquire whether the patient has a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema. Additionally, caution should be exercised if the cough is accompanied by excessive phlegm (mucus).

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: sore mouth does not improve within 7 days; cough persists for more than 1 week, recurs, or is accompanied by fever, rash, or persistent headache, as these symptoms may signify a serious underlying condition; or if irritation, pain, or redness persists or worsens.

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

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include severe or persistent sore throat, particularly when accompanied by high fever, headache, rash, swelling, nausea, or vomiting. Such symptoms warrant immediate consultation with a healthcare provider. It is advised that patients do not use the medication for more than 2 days unless directed by a doctor.

Common adverse reactions that necessitate discontinuation of use and consultation with a healthcare provider include a sore mouth that does not improve within 7 days, a cough that persists for more than 1 week, recurs, or is accompanied by fever, rash, or persistent headache. These symptoms may indicate a serious underlying condition. Additionally, if irritation, pain, or redness persists or worsens, patients should seek medical advice.

Patients are also advised to consult a doctor before using this 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).

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 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

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 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. 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 are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific concerns have been identified in the available information.

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 risks associated with excessive dosing of the medication.

Healthcare providers should be aware that symptoms of overdosage may vary depending on the pharmacological properties of the drug in question. In cases where overdosage is suspected, it is recommended to monitor the patient closely for any adverse effects or unusual clinical signs.

Management of overdosage should include supportive care tailored to the patient's clinical presentation. This may involve the administration of activated charcoal if the ingestion occurred within a suitable timeframe and the patient is alert. Additionally, symptomatic treatment should be provided as necessary, and healthcare professionals should consider contacting a poison control center for further guidance.

In all instances of suspected overdosage, it is crucial to document the event thoroughly and report it to the appropriate regulatory authorities as per local guidelines. Continuous education on the signs and management of overdosage is vital for ensuring patient safety and effective treatment outcomes.

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

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 temperature ranges to maintain its integrity. Containers should be secure and suitable for the product type to prevent contamination or degradation. Special handling requirements, if any, should be determined based on the product's characteristics and standard industry guidelines.

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)