Revive 2

Description

The drug is identified by the SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with the letter "A" on one side and the number "1" on the opposite side. The chemical name is insert chemical name here. Inactive ingredients comprise lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, and additional components as specified.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

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

Dosage and Administration

For adults and children over 12 years of age, it is essential to shake the product well before each use. The recommended application involves generously applying the formulation to the affected area and massaging it into the painful area until it is completely absorbed. This process may be repeated 4 to 6 times a day or as needed, depending on the severity of symptoms.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing and administration guidance.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should advise patients against bandaging the treated area tightly or using it in conjunction with a heating pad. It is imperative to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or any damaged, broken, or irritated skin. Patients may experience a transient burning sensation or redness upon application; however, these effects typically resolve within several days. Should a severe burning sensation occur, patients are instructed to discontinue use immediately. Additionally, the treated area should not be exposed to heat or direct sunlight.

This product is flammable; therefore, it should be kept away from fire or flame. Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use.

Patients should be instructed to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

General precautions include keeping the product out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients using this product should be aware that it is for external use only and must be applied strictly as directed. It is important to avoid bandaging the area tightly or using it in conjunction with a heating pad. Contact with the eyes and mucous membranes should be avoided, and the product should not be applied to wounds or damaged, broken, or irritated skin.

Upon application, patients may experience a transient burning sensation or redness, which typically resolves within several days. However, if a severe burning sensation occurs, patients are advised to discontinue use immediately. Additionally, the treated area should not be exposed to heat or direct sunlight.

Patients should stop using the product and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. The product is flammable, and patients should keep it away from fire or flame.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center without delay. Pregnant or breastfeeding individuals are advised to consult a healthcare professional before using this product.

Drug Interactions

There are currently no known drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no specific dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Revive 2 (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult their healthcare provider before use. The safety and efficacy of this medication in this age group have not been established, and specific dosing recommendations are not provided for children in this category. It is essential for healthcare professionals to evaluate the individual needs of pediatric patients and consider alternative treatments as necessary.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 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 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, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial to ensure the safety and well-being of patients and to mitigate any potential risks associated with accidental ingestion.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ensuring that it is kept away from fire or flame to maintain safety and efficacy. Prior to each use, it is essential to shake the product well to ensure proper mixing and effectiveness.

Additional Clinical Information

For adults and children over 12 years, the recommended administration involves applying the product generously to the affected area and massaging it into the painful area until fully absorbed. This can be done 4 to 6 times a day or as needed. For children under 12 years, it is advised to consult a doctor before use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, 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 should be sought immediately.

Drug Information (PDF)

This file contains official product information for Revive 2, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)