Goodsense Extra Strength Cold and Hot Medicated

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the relief of symptoms in adults and children over 12 years of age. It may be used for a duration of up to 8 hours and should not be administered more than 3 times a day.

For children 12 years of age or younger, it is recommended to consult a physician prior to use.

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

Dosage and Administration

No dosage and administration information is available for this product. Healthcare professionals are advised to consult the prescribing information or relevant clinical guidelines for specific dosing recommendations and administration techniques.

Contraindications

Use is contraindicated in infants.

Due to the risk of serious adverse effects, the product should be kept out of reach of children. In the event of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

The product should not be applied with tight bandaging or in conjunction with heating pads, as this may exacerbate potential side effects. Additionally, contact with eyes and mucous membranes must be avoided to prevent irritation. Application to wounds or damaged skin is also contraindicated to ensure safety and efficacy.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children and to avoid application on infants. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, redness develops, irritation arises, or if symptoms persist for more than seven days or resolve only to recur within a few days. These precautions are essential to ensure patient safety and effective management of any adverse reactions.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist for more than 7 days or resolve and then recur within a few days. These reactions warrant medical attention to ensure appropriate management and to prevent potential complications.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Goodsense Extra Strength Cold and Hot Medicated (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not use this medication without consulting a healthcare professional. It is advised to keep the product out of reach of children. The use of this medication is contraindicated in infants. For children aged 12 years or younger, a doctor's guidance is necessary prior to use.

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 therapeutic response, 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 on the excretion of this drug 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 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, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient effectively.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

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

Reports of serious side effects associated with the use of this product have been received through voluntary submissions and surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the designated address: 17211 Valley View Ave., Cerritos, CA 90703.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children and to avoid using it on infants. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if any of the following occur: the condition worsens, redness appears, irritation develops, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

When using this product, it is essential for patients to follow the directions provided. They should be cautioned against bandaging the area tightly or using a heating pad in conjunction with the product. Additionally, patients must avoid contact with the eyes and mucous membranes and should not apply the product to wounds or damaged skin.

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 at room temperature, ensuring that the temperature does not exceed 86°F (30°C). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The product is administered topically and should be applied for a maximum duration of 8 hours, not exceeding three applications per day. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the product out of reach of children and to avoid use on infants. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Additionally, reports of serious side effects associated with the use of this product can be directed to the specified address in Cerritos, CA. No further information is available regarding laboratory tests or abuse potential.

Drug Information (PDF)

This file contains official product information for Goodsense Extra Strength Cold and Hot Medicated, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)