Elgin Pain Relief

Description

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

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints, including those related to arthritis, backache, strains, and sprains.

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

Dosage and Administration

Adults and children aged 2 years and older are instructed to apply the product to painful muscles and joints. The application should involve gently massaging the formulation thoroughly into the affected area. This process may be repeated as necessary, but should not exceed four applications within a 24-hour period.

The product is intended for topical application only, and the method of administration requires careful massage into the targeted area to ensure optimal absorption and efficacy.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. The use of this product in conjunction with other ointments, creams, sprays, or liniments is not recommended, as it may lead to unpredictable interactions. It should not be applied to irritated skin or in cases where excessive irritation develops, as this may exacerbate the condition. Bandaging the area after application is contraindicated to prevent occlusion and potential complications. Additionally, the use of heating pads or devices in conjunction with this product is not advised, as it may increase the risk of irritation or adverse reactions.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes or mucous membranes. The product should not be applied to wounds or damaged skin, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Application to irritated skin is contraindicated, and if excessive irritation develops, use should be discontinued. Bandaging the area after application is not recommended. Following use, hands should be washed thoroughly with cool water. Additionally, the product should not be used in conjunction with heating pads or devices.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact should be made with a Poison Control Center.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur. Additionally, individuals with sensitive skin should seek medical advice before using this product.

Drug Interactions

Co-administration of this product with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of heating pads or devices in conjunction with this product is also not recommended, as it may lead to adverse effects.

There are no specific interactions identified with laboratory tests associated with this product. Therefore, no adjustments or special monitoring are required in this context.

Packaging & NDC

Below are the non-prescription pack sizes of Elgin Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

For external use only. Pediatric patients aged 2 years and older may apply the product to painful muscles and joints, with gentle massage into the affected area. The application may be repeated as necessary, but should not exceed four times daily. It is important to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought or contact with a Poison Control Center is advised.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in 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 in these populations. There is limited data available regarding the effects of this medication on fetal outcomes or during lactation, and therefore, healthcare providers should exercise caution and provide appropriate guidance to patients who are pregnant or nursing.

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 mothers.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, specific antidotes or treatments may be indicated depending on the substance involved in the overdose. It is crucial for healthcare professionals to consult relevant clinical guidelines and toxicology resources to determine the most effective management strategies tailored to the individual case.

In summary, while no specific overdosage information is available, vigilance and prompt intervention are paramount in managing potential overdose situations.

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 for SPL code 90375-7.

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 help or contact a Poison Control Center immediately.

Patients should be instructed 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 reoccur.

When using this product, patients must avoid contact with the eyes and mucous membranes. They should not apply the product to wounds or damaged skin, nor should they use it in conjunction with other ointments, creams, sprays, or liniments. Patients should also refrain from applying the product to irritated skin and should discontinue use if excessive irritation develops. It is important to inform patients that they should not bandage the area after application and should wash their hands with cool water after use. Additionally, patients should be cautioned against using the product with a heating pad or any heating device.

Healthcare providers should encourage patients to consult a doctor before use if they have sensitive skin.

Storage and Handling

The product is supplied in a container that must be stored in a cool, dry place. It is essential to ensure that the lid is closed tightly to maintain the integrity of the product. Proper storage conditions are critical to preserving the quality and efficacy of the product.

Additional Clinical Information

Patients should apply the product to painful muscles and joints, gently massaging it thoroughly into the affected area. This application can be repeated as necessary, but should not exceed four times daily.

Clinicians should counsel patients to consult a doctor prior to use if they have sensitive skin. It is important to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds, damaged, or irritated skin. Patients should refrain from using it in conjunction with other ointments, creams, sprays, or liniments, and should not bandage the area after application. Hands should be washed with cool water after use, and the product should not be used with heating pads or devices. Pregnant or breastfeeding patients are advised to seek professional guidance before use. Additionally, the product should be kept out of reach of children, and in the event of accidental ingestion, medical help or contact with a Poison Control Center should be sought.

Drug Information (PDF)

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

View product document (PDF)