Extra Strength Cold-Hot Medicated Patches

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "A" on one side and "123" on the opposite side. It contains 500 mg of Acetaminophen as the active ingredient. The formulation includes several inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises, and cramps.

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

Dosage and Administration

Adults and children 12 years of age and over should follow these instructions for patch application. The backing of the patch must be carefully removed, and the sticky side should be applied directly to the affected area. Each patch may be worn for a maximum of 8 hours. If necessary, the application may be repeated, but it should not exceed 4 patches in a 24-hour period. After opening, the pouch should be resealed to maintain the integrity of the remaining patches. Each patch is for single use only and must be discarded after removal.

For children under 12 years of age, it is essential to consult a physician before use.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the application of a heating pad is not recommended, as this may exacerbate adverse effects. Contact with the eyes and mucous membranes should be strictly avoided to prevent irritation or injury. Additionally, application to wounds or damaged skin is contraindicated due to the potential for increased sensitivity and adverse reactions.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to seek emergency medical assistance immediately if the product is ingested. In such cases, contacting a Poison Control Center is strongly recommended.

Patients should be instructed to discontinue use and consult their healthcare provider under the following circumstances: if the condition worsens, if any redness appears, if irritation develops, or if symptoms persist for more than seven days. Additionally, if symptoms resolve and then recur within a few days, patients should also stop using the product and seek medical advice.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens, if redness is present, if irritation develops, or if symptoms persist for more than 7 days or clear up and then occur again within a few days.

Drug Interactions

No specific drug interactions have been identified for the product. Additionally, there are no reported interactions with laboratory tests. 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 Extra Strength Cold-Hot Medicated Patches (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should be evaluated by a physician prior to use. It is essential to consider the specific needs and potential risks associated with this age group when determining treatment options.

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 efficacy, 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 considered, 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 breastfeeding.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that they should monitor their condition closely and report to their healthcare provider if any of the following occur: worsening of their condition, the presence of redness, the development of irritation, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

Patients should be instructed to use the product strictly as directed. They should be cautioned against bandaging the area tightly or using the product in conjunction with a heating pad. Additionally, patients must be made aware to avoid contact with their eyes and mucous membranes, and they should not apply the product to wounds or damaged skin.

Storage and Handling

The product is supplied in pouches that must be resealed after opening to maintain integrity. It is essential to store the product at room temperature to ensure optimal performance. Each patch is intended for single use only and should be discarded after application.

Additional Clinical Information

The product is administered topically, with specific instructions for adults and children aged 12 years and older. Patients should carefully remove the backing from the patch and apply the sticky side to the affected area, wearing the patch for up to 8 hours. It may be repeated as necessary, but no more than four times daily. After use, the patch should be discarded, and the pouch resealed. For children under 12 years of age, consultation with a physician is advised.

Clinicians should counsel patients on proper usage, emphasizing that the product should be used only as directed. Patients are advised not to bandage tightly or use with a heating pad, and to avoid contact with eyes and mucous membranes. The patch should not be applied to wounds or damaged skin. Patients should discontinue use and consult a doctor if the condition worsens, if redness or irritation develops, or if symptoms persist for more than 7 days or recur shortly after resolution. Pregnant or breastfeeding patients should seek advice from a health professional before use.

Drug Information (PDF)

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

View product document (PDF)