Dollar General Cold-Hot Medicated Patches

Description

The drug is identified by the SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "34089" on one side and "3" on the opposite side. Each tablet contains 3 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. The tablets are packaged in bottles containing 30 units.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various musculoskeletal 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 over 12 years of age should carefully remove the backing from the patch and apply the sticky side directly to the affected area. Each patch may be worn for a maximum of 8 hours. If necessary, the application may be repeated, but no more than 4 patches should be applied in a 24-hour period. After opening, the pouch should be resealed to maintain the integrity of the remaining patches.

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

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. Additionally, contact with the eyes and mucous membranes should be strictly avoided to prevent irritation or injury. The application of this product on 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 discontinue use and seek medical attention under the following circumstances: if the condition worsens, if redness is observed, if irritation develops, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

In the event of accidental ingestion, it is imperative to obtain emergency medical assistance or contact a Poison Control Center immediately.

Side Effects

Patients should be aware that the product is intended for external use only. In clinical practice, it is advised that patients discontinue use and consult a healthcare professional under certain circumstances. Specifically, patients should seek medical advice if their condition worsens, if redness is present, if irritation develops, or if symptoms persist for more than 7 days or resolve only to recur within a few days. These recommendations are based on clinical observations and are intended to ensure patient safety and effective management of their condition.

Drug Interactions

No specific drug interactions have been identified for this medication. 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 Dollar General Cold-Hot Medicated Patches (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger 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

There is no specific information available 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before 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 regarding the excretion of this medication 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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 indicated based on the clinical scenario and the substance involved. Additionally, contacting a poison control center can provide valuable guidance on the management of overdose cases.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose situation effectively.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to use the medication only as directed. It is important to inform patients not to bandage the area tightly or use a heating pad in conjunction with the medication, as this may lead to adverse effects.

Patients should be cautioned to avoid contact with the eyes and mucous membranes to prevent irritation or injury. Additionally, healthcare providers should instruct patients not to apply the medication to wounds or damaged skin, as this could compromise healing or exacerbate the condition.

Storage and Handling

The product is supplied in pouches that must be resealed after opening to maintain integrity. It should be stored at room temperature, ensuring that it is kept out of reach of children to prevent accidental ingestion. Proper handling and storage conditions are essential to preserve the quality and safety of the product.

Additional Clinical Information

The product is administered topically, with specific instructions for different age groups. Adults and children over 12 years 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. This can be repeated as necessary, but no more than four times daily. For children 12 years or younger, consultation with a physician is advised prior to use.

Clinicians should counsel patients to use the product only as directed, avoiding tight bandaging or the use of heating pads. Contact with eyes and mucous membranes should be avoided, and the product should not be applied to wounds or damaged skin. Patients are advised to discontinue use and consult a doctor if the condition worsens, if redness or irritation occurs, or if symptoms persist beyond 7 days or recur shortly after resolution. Pregnant or breastfeeding patients should seek professional advice before use.

Drug Information (PDF)

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

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