Assured Extra Strength Cold N Hot

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children aged 12 years and older, with application not exceeding 3 to 4 times daily.

For children under 12 years of age, the use of this drug is not recommended without prior consultation with a healthcare professional.

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

Dosage and Administration

No dosage and administration information is provided in the text.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the application of a heating pad in conjunction with this product is not recommended, as it may lead to adverse effects.

Contact with the eyes and mucous membranes should be strictly avoided to prevent irritation or injury.

Application to wounds or damaged skin is contraindicated due to the potential for exacerbating the condition or causing further harm.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a health professional prior to use if they are pregnant or breastfeeding.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance immediately. Patients should be instructed to keep the product out of reach of children. If swallowed, they should contact a Poison Control Center without delay.

Patients should be advised to discontinue use and consult their healthcare provider if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, redness appears, or skin irritation develops. Monitoring for these signs is essential to ensure patient safety and effective management of their condition.

Side Effects

For external use only. Patients are advised to consult a health professional if they are pregnant or breastfeeding before using this product.

Participants should discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, redness is present, or skin irritation develops.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a healthcare professional. For adolescents and adults aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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 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 no specific data available regarding the excretion of this medication in 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 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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as per established protocols. Additionally, healthcare professionals should consider contacting a poison control center for guidance on the management of the overdose and to obtain further recommendations tailored to the specific situation.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management and follow-up 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 use of the compound in question.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. 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, symptoms persist for more than 7 days or resolve and then recur within a few days, redness appears, or if skin irritation develops.

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

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years of age, it is advised to consult a doctor before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)