Rite Aid Ultra Strength Muscle Rub

Description

Rite Aid Ultra Strength Muscle Rub is a topical formulation designed for muscle relief. The product is presented in a 4-ounce dosage form. It is characterized by its effective time, which is noted as March 1, 2023. The media type associated with this product is image/jpeg, and it is referenced with the value 64-216PF 0223 PKG Muscle rub 4oz.jpg.

Uses and Indications

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

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 the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed gently and that the area is clean and dry prior to use.

For children under 12 years of age, it is advised to consult a physician before application to determine the appropriate course of action.

Contraindications

Use is contraindicated in the following situations:

Application on wounds or damaged skin is prohibited due to the potential for irritation and adverse reactions. The use of a heating pad in conjunction with this product is contraindicated, as it may increase the risk of burns or skin damage. Additionally, the product should not be used in children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

While using the product, it is essential to avoid contact with eyes or mucous membranes to prevent irritation. Furthermore, tight bandaging is not recommended, as it may impede circulation and lead to complications.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a physician prior to use if there is any redness present over the affected area, as this may indicate a more serious condition that requires medical evaluation.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients are encouraged to contact a Poison Control Center at 1-800-222-1222 for guidance.

Patients should be instructed to discontinue use and consult a healthcare provider if the condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days. These precautions are essential to ensure patient safety and effective management of their condition.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, it is advised that patients seek medical advice before use if there is redness over the affected area.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Rite Aid Ultra Strength Muscle Rub (methyl salicylate 30.0%, camphor 4.0%, menthol 10.0%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients with arthritis-like conditions under 12 years of age should not be treated with this medication. For children in this age group, it is essential to consult a physician before use.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be advised against using this product on wounds or damaged skin. It is important for healthcare professionals to inquire about any redness over the affected area before recommending use. If the condition worsens or symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, patients should be instructed to discontinue use and consult a physician.

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is recommended. For children under 12 years of age, consultation with a physician is necessary prior to use.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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 individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consider contacting a poison control center for guidance on specific management protocols and interventions tailored to the substance involved.

Documentation of the incident, including the amount and timing of the overdose, is crucial for ongoing management and treatment decisions.

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 seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. It is important to instruct patients not to apply the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad.

Patients should be informed that the product is not recommended for use on children under 12 years of age who have arthritis-like conditions. They should be counseled to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days, or if symptoms improve and then recur within a few days.

When using the product, patients must be reminded to follow the directions carefully and to avoid contact with the eyes or mucous membranes. Additionally, they should not apply a tight bandage over the area of application. It is advisable for patients to consult a doctor before use if there is any redness present over the affected area.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy. It is imperative that the product is not used if the tube seal under the cap is broken, as this may compromise the integrity of the product. Proper handling and storage conditions are essential to ensure the product remains safe and effective for use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Rite Aid Ultra Strength Muscle Rub, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)