Meijer Maximum Strength Pain Relieving

Description

Menthol 16% is a pain-relieving liquid formulated for topical application. Each container holds 2.5 fluid ounces (74 mL) of the product, which features a no-mess applicator designed to facilitate clean application without contaminating the hands. This formulation provides powerful, fast, and effective pain relief while ensuring that it does not stain surfaces.

Uses and Indications

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

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

Dosage and Administration

Adults and children 12 years of age and older should apply the medication generously to the affected area. The application should be followed by a gentle massage into the painful area until the product is thoroughly absorbed into the skin. This process may be repeated if necessary, but should not exceed 3 to 4 applications per day. In the event that the medicine comes into contact with the hands, it is important to wash the hands with soap and water immediately.

For children 12 years of age and younger, it is advised to consult a doctor 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 this 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.

Contact with the eyes and mucous membranes must be avoided to prevent irritation. Application to wounds or damaged skin is contraindicated, as is the use of tight bandages 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 or skin irritation, the use of the product should be discontinued immediately, and a healthcare professional should be consulted. Users may experience a transient burning sensation upon application; however, this typically resolves within several days. Should the condition worsen or if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days, it is imperative to cease use and seek medical advice.

This product must be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only, and it is recommended that a small patch of skin be tested prior to generous application.

During use, if redness or skin irritation occurs, patients should discontinue use and consult a healthcare professional. A transient burning sensation may be experienced upon application; however, this sensation typically resolves within several days.

Patients are advised to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

It is crucial to avoid applying the product to wounds or damaged skin, and patients should not bandage the area tightly. Additionally, the product should not be used in conjunction with heating pads or other heating devices due to safety concerns.

Patients should also be aware that the product is flammable and should be kept away from fire or flame.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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.

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 in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is no specific data available 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 drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 event of an overdosage, it is imperative to seek immediate medical assistance. If the substance is ingested, healthcare professionals should be contacted without delay, or the individual should reach out to a Poison Control Center for guidance.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Healthcare providers are advised to assess the situation thoroughly and initiate appropriate management protocols based on the specific circumstances and symptoms presented.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. A transient burning sensation may occur upon application; however, this effect generally resolves within several days. No specific information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Additionally, there is no specific information provided concerning animal pharmacology and toxicology.

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. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. It is important to emphasize that they should discontinue use and seek medical advice under these circumstances.

When using this product, patients must be instructed to use it only as directed. They should avoid contact with the eyes and mucous membranes, and not apply the product to wounds or damaged skin. Additionally, patients should be cautioned against bandaging the area tightly and using the product in conjunction with heating pads or other heating devices.

Patients should be made aware that if redness is present, they should discontinue use and consult a doctor. They should also be informed that if skin irritation occurs, they should stop using the product. It is important to note that a transient burning sensation may occur upon application, but this generally disappears within several days.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

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 that the product is for external use only and recommend testing on a small patch of skin prior to generous application. Pregnant or breastfeeding patients should consult a healthcare professional before use. It is important 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 necessary. Patients should discontinue use and consult a doctor if redness or skin irritation occurs.

Drug Information (PDF)

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

View product document (PDF)