Cvs Maximum Strength Cold and Hot Pain Relief

Description

Menthol is present at a concentration of 16% in this formulation. The product is contained in a 2.5 fluid ounce (73 mL) bottle.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains in muscles and joints associated with conditions such as simple backache, arthritis, strains, bruises, sprains, and cramps.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to apply the medication generously to the affected area. The product should be massaged into the painful area until it is thoroughly absorbed into the skin. This application may be repeated as necessary, but should not exceed 3 to 4 times daily. In the event that the medication comes into contact with the hands, it is advised to wash the hands with soap and water.

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

Contraindications

The product is contraindicated for application to wounds or damaged skin due to the potential for irritation or adverse effects. Additionally, it should not be bandaged tightly, as this may impede circulation. The use of heating pads or other heating devices in conjunction with the product is also contraindicated, as it may lead to increased absorption and potential toxicity.

Warnings and Precautions

For external use only; prior to extensive application, it is recommended to conduct a patch test on a small area of skin to assess for any adverse reactions. The product should be utilized strictly as directed to ensure safety and efficacy.

Healthcare professionals should advise patients to avoid contact with the eyes. Application to wounds or damaged skin is contraindicated, as is the use of tight bandaging over the treated area. Additionally, the product should not be used in conjunction with heating pads or other heating devices, as this may exacerbate skin reactions.

In the event of redness, irritation, or any worsening of the condition, patients should discontinue use immediately and seek medical advice. It is crucial to stop use and consult a healthcare provider 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 only to recur within a few days.

This product should be kept out of reach of children. In the case of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients using this product may experience various adverse reactions, which can be categorized based on seriousness and frequency.

Warnings indicate that the product is for external use only, and it is essential for patients to test it on a small patch of skin before applying it generously. When using this product, patients should adhere strictly to the directions provided. It is crucial to avoid contact with the eyes and to refrain from applying the product to wounds or damaged skin. Additionally, patients should not bandage the area tightly or use the product in conjunction with heating pads or other heating devices.

In the event of redness or skin irritation, patients are advised to discontinue use and consult a healthcare professional. Furthermore, patients should stop using the product and seek medical advice if their condition worsens, if redness is present, if irritation develops, or if symptoms persist for more than seven days or resolve only to recur within a few days.

Additional important notes include the necessity of keeping the product out of reach of children. In cases of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately. The product is also flammable, and patients are advised to keep it away from fire or flame.

Drug Interactions

The use of this medication is contraindicated with heating pads or other heating devices, as the combination may lead to adverse effects.

There are no specific interactions identified with laboratory tests associated with this medication. Therefore, routine monitoring of laboratory tests is not required in relation to this drug.

Packaging & NDC

Below are the non-prescription pack sizes of Cvs Maximum Strength Cold and Hot Pain Relief (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

For dosing instructions, adults and children aged 12 years and older may follow the specified directions. However, for children under 12 years of age, it is recommended to consult a doctor before use.

Geriatric Use

There is no specific information 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. 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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. It is essential to evaluate the potential risks and benefits associated with the use of this medication during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 not been specifically addressed in the drug insert 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 data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 in the insert text.

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 stop using the product and consult a healthcare professional if any of the following occur: the condition worsens, redness develops, irritation occurs, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

When using this product, patients must be reminded to use it only as directed. They should avoid contact with the eyes and refrain from applying the product to wounds or damaged skin. It is important to inform patients not to bandage the area tightly or use it in conjunction with heating pads or other heating devices. If redness is observed, patients should discontinue use and seek medical advice. Additionally, if skin irritation develops, they should stop using the product.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature, away from sources of fire or flame to maintain its integrity and efficacy.

In the event that the medicine comes into contact with hands, it is essential to wash the affected area thoroughly with soap and water to ensure safety and hygiene.

Additional Clinical Information

The product is intended for topical administration, with patients advised to apply it generously to the affected area and massage it into the skin until fully absorbed. This application may be repeated as necessary, but should not exceed 3 to 4 times daily.

Clinicians should counsel patients on the following: the product is for external use only, and a patch test should be conducted prior to generous application. Pregnant or breastfeeding patients should consult a healthcare professional before use. It is crucial to keep the product out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center is recommended. Patients should discontinue use and consult a doctor if redness or skin irritation occurs, if the condition worsens, or if symptoms persist for more than 7 days or recur shortly after resolution.

Drug Information (PDF)

This file contains official product information for Cvs Maximum Strength Cold and Hot Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)