Sugar Brands Rescue Pain Relief and Recovery

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of pain. It is intended for use in patients experiencing acute pain conditions. Healthcare professionals should assess the appropriateness of this medication based on individual patient needs and the specific pain management requirements.

Dosage and Administration

For adults and children aged two years and older, the recommended application is to the affected area not more than three to four times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under two years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

Contraindications

Use is contraindicated in patients who may apply the product in large quantities, especially over raw surfaces or blistered areas, due to the potential for adverse effects in these conditions. No other contraindications have been identified.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. In the event that symptoms persist for more than seven days, the product should be discontinued, and a physician should be consulted for further evaluation and management.

In cases of accidental ingestion, it is essential to seek medical advice promptly. The product should not be applied in large quantities, especially on raw surfaces or blistered areas, as this may exacerbate irritation or lead to adverse effects.

Healthcare professionals should advise patients who are pregnant or breastfeeding to consult with their physician prior to using this product to ensure safety for both the mother and child.

Side Effects

Patients should be aware that the product is intended for external use only and must avoid contact with the eyes. In the event that symptoms persist for more than seven days, it is advised to discontinue use and consult a physician.

Additionally, the product should be kept out of reach of children. If swallowed, it is important to seek medical advice immediately.

Patients are cautioned against using the product in large quantities, especially over raw surfaces or blistered areas, as this may lead to adverse effects.

For those who are pregnant or breastfeeding, it is recommended to contact a physician prior to use to ensure safety and appropriateness of the product.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Sugar Brands Rescue Pain Relief and Recovery (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged two years and older may apply the medication to the affected area no more than three to four times daily. For children under two years of age, it is advised to consult a physician prior to 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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should contact their physician prior to using this medication. It is essential for healthcare providers 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 optimal fetal outcomes.

Lactation

Lactating mothers are advised to contact their physician prior to using this medication. There is currently no available data on the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution when prescribing this medication to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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 that healthcare professionals take immediate action. If the product is ingested, the first step is to consult a physician for further evaluation and management.

Potential symptoms of overdosage may vary depending on the specific circumstances and the amount ingested. It is crucial for healthcare providers to monitor the patient closely for any adverse effects that may arise.

Management procedures should be initiated promptly, guided by the physician's recommendations. This may include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is essential to ensure appropriate interventions are implemented.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to contact a physician prior to use. There are no specific non-teratogenic effects or nonclinical toxicology details available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients that if the medication is swallowed, they should consult their physician immediately. It is important for patients to understand the potential implications of swallowing the medication and to seek professional guidance without delay.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered topically, with application to the affected area not exceeding three to four times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)