Gems

Description

No description information is available for the 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 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 should refrain from using the product for more than two days unless specifically directed by a physician.

Healthcare professionals should advise patients to seek medical guidance prior to use if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema. Additionally, individuals with a cough that is accompanied by excessive phlegm (mucus) should also consult a doctor before use.

Patients are instructed to discontinue use and consult a healthcare provider if the following conditions occur: sore mouth does not show improvement within seven days; cough persists for more than one 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.

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

Side Effects

Patients may experience a range of adverse reactions, which can vary in seriousness and frequency.

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. It is recommended that the product not be used for more than 2 days unless directed by a healthcare professional.

Before using the product, patients should seek medical advice 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).

Patients should discontinue use and consult a doctor if the sore mouth does not improve within 7 days, if the cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may be signs of a serious condition. Additionally, if irritation, pain, or redness persists or worsens, medical advice should be sought.

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

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 adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use, as there may be potential risks to the fetus. Further studies are needed to determine the safety profile of this product in pregnant individuals.

Dosage adjustments may be necessary for pregnant individuals; therefore, it is essential to seek guidance from a healthcare provider regarding appropriate dosing. Special precautions should be taken, and this product should be used during pregnancy only if clearly needed, with a careful consideration of whether the potential benefits justify the potential risks to the fetus.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 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 any 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. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, gastrointestinal disturbances, and respiratory difficulties.

Management of an overdose should be tailored to the specific substance involved and may include supportive care, symptomatic treatment, and, if applicable, the use of antidotes. It is crucial to consult local poison control centers or relevant clinical guidelines for specific recommendations on the management of overdose situations.

In summary, while no specific overdosage information is provided, healthcare professionals should be prepared to act swiftly and effectively in the event of an overdose, ensuring patient safety and optimal care.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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 discontinue use 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 for healthcare providers to recommend that patients seek medical guidance before using the medication if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema. Patients should be cautioned to consult a doctor if their cough is accompanied by excessive phlegm (mucus), as this may require further evaluation.

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 needs 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)