Ultra Vedic

Description

ULTRA VEDIC is a medicated feminine pain relief patch designed to alleviate menstrual discomfort. Each pack contains five patches, which are formulated for fast-acting relief from period cramps. The patches are intended for application for a duration of 8 to 12 hours, providing targeted support during menstruation. The product is identified by the National Drug Code (NDC) 72625-130-05.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains in the lower back and abdomen associated with cramps.

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

Dosage and Administration

For adults and children aged 12 years and older, the patch should be applied to the affected area no more than twice daily. Prior to application, it is essential to ensure that the skin at the application site is completely dry.

To apply the patch, open the pouch and remove the patch. Peel off the protective film and adhere the sticky side of the patch to the affected area. In cases where the patch is applied to hairy skin, it should be removed gently using mild warm water to minimize discomfort.

Once the patch has been used, it cannot be re-pasted or reused. Proper disposal of the patch after use is required to ensure safety and hygiene.

Contraindications

The product is contraindicated for use on open wounds, cuts, the eyes, and the face due to the potential for irritation and adverse reactions. Additionally, the application of this product in conjunction with a heating pad is contraindicated, as it may lead to increased risk of burns or skin damage.

During use, it is essential to avoid contact with the eyes and 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; this product should not be used in any manner other than as directed. It is imperative to avoid contact with the eyes and mucous membranes, as such contact may lead to irritation or adverse effects. Additionally, users should refrain from applying tight bandages over the treated area to prevent complications.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days. Furthermore, if any abnormal skin irritation occurs following application, it is essential to stop using the product and seek medical advice.

Side Effects

Patients should be aware that the product is for external use only and should not be used otherwise than as directed.

In clinical practice, it is advised that patients 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. Additionally, patients should seek medical advice if they experience abnormal skin irritation following usage.

Before using the product, patients are encouraged to consult their doctor if they have redness over the affected area, have sensitive skin, or are pregnant or breastfeeding. These considerations are important to ensure the safe and effective use of the product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions between this medication and laboratory tests. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Ultra Vedic (feminine pain relief). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may use this medication. The recommended application frequency is no more than twice daily to the affected area. Safety and efficacy have not been established in children under 12 years of age.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, may use this medication; however, there are no specific geriatric use information or dosage adjustments indicated in the prescribing information. Additionally, no safety concerns or special precautions for elderly patients have been provided.

Healthcare providers should continue to monitor the overall health status of geriatric patients and consider individual patient factors when prescribing this medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult their healthcare provider before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully known. Therefore, it is essential for women of childbearing potential to discuss their individual circumstances with their healthcare professional to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult their healthcare provider prior to using this medication if they are breastfeeding. There is no specific data available regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should consider the potential risks and benefits when recommending 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 clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

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 tailored to the substance involved in the overdose.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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 insert text.

Patient Counseling

Healthcare providers should advise patients to seek medical help or contact a Poison Control Center immediately if the product is swallowed. It is important to instruct patients not to use the product on open wounds, cuts, the eyes, or the face, and to avoid using it in conjunction with a heating pad.

Patients should be informed to stop using the product and consult their doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, they should be advised to discontinue use and seek medical advice if they experience any abnormal skin irritation after application.

While using the product, patients must be cautioned to avoid contact with the eyes and mucous membranes. They should also be instructed not to bandage the area tightly after application.

Healthcare providers should encourage patients to consult their doctor before using the product if they have redness over the affected area, have sensitive skin, or are pregnant or breastfeeding.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that the temperature does not exceed 80°F (27°C).

After opening, the container should be resealed to maintain product integrity. Proper disposal methods must be followed after use to ensure safety and compliance with regulations.

Additional Clinical Information

The medication is administered topically, with a recommended application to the affected area not exceeding two times per day. 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 Ultra Vedic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)