Revive 1

Description

Revive 1 is a pharmaceutical formulation designed for specific therapeutic applications. The product's active ingredient is characterized by its unique molecular structure, contributing to its efficacy. The chemical formula and molecular weight are critical for understanding its pharmacokinetics and pharmacodynamics. Revive 1 is presented in a dosage form that ensures optimal delivery and absorption. The formulation is designed to maintain stability and integrity throughout its shelf life, ensuring consistent performance in clinical settings. The appearance of Revive 1 is consistent with industry standards for pharmaceutical products, facilitating identification and handling in professional environments.

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, the product should be shaken well before each use. A generous amount should be applied to the affected area, followed by a thorough massage into the skin until fully absorbed. This application may be repeated as necessary, but should not exceed 3 to 4 times daily.

For children 12 years of age or younger, it is advised to consult a physician before use.

Contraindications

Use is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion.

• In the event of accidental swallowing, immediate medical assistance or contact with a Poison Control Center is required.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should advise patients against bandaging the 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, it is crucial to discontinue use immediately. Additionally, the treated area should not be exposed to heat or direct sunlight to prevent exacerbation of any adverse effects.

Patients are advised to stop use and consult a healthcare provider if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

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

To ensure safety, the product must 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.

Side Effects

Patients should be aware that this product is for external use only and must be used strictly as directed. It is important to avoid bandaging tightly or using the product in conjunction with a heating pad. Contact with 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. It is also important to note that the product is flammable; therefore, it should be kept away from fire or flame. Pregnant or breastfeeding patients should seek advice from a healthcare professional before using this product.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Revive 1 (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional prior to use. It is important for caregivers to seek medical advice to ensure the safety and appropriateness of treatment for this age group.

Geriatric Use

There is no specific information available 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 health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the insert text. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the lack of data necessitates careful consideration of individual patient circumstances.

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.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is recommended to ensure optimal patient care and safety.

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 keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

Storage and Handling

The product is supplied in configurations that are compliant with the National Drug Code (NDC) standards. 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

The product is administered topically, with specific instructions for adults and children over 12 years. Patients should shake the product well before each use, 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. 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; if ingested, immediate medical assistance or contact with a Poison Control Center is recommended.

Drug Information (PDF)

This file contains official product information for Revive 1, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)