Healthwise Menstrual Pain Relief Patch

Description

The product is identified by SPL Code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "123" on the other. Each tablet contains 500 mg of Acetaminophen. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.

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

Adults and children aged 12 years and older should carefully remove the backing from the patch and apply the sticky side directly to the affected area. Each patch may be worn for a duration of 8 to 12 hours. The application may be repeated as necessary, but should not exceed two applications within a 24-hour period. After use, the patch must be properly discarded.

For children under 12 years of age, it is recommended to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

• Application should not involve tight bandaging or the use of heating pads, as this may exacerbate adverse effects.

• Contact with the eyes and mucous membranes must be avoided to prevent irritation or injury.

• The product should not be applied to wounds or damaged skin due to the risk of increased absorption and potential systemic effects.

• Concurrent use with other topical analgesics is contraindicated to avoid additive effects and potential toxicity.

Warnings and Precautions

For external use only. This product must be kept out of reach of children. In the event of ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

It is imperative to use this product strictly as directed. There have been rare reports of serious burns associated with similar products. To minimize risk, do not apply a tight bandage over the area of application, nor should it be used in conjunction with a heating pad. Care should be taken to avoid contact with the eyes and mucous membranes. The product must not be applied to wounds or damaged skin, and concurrent use with other topical analgesics is contraindicated.

Healthcare professionals should advise patients to discontinue use and seek medical consultation if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should be instructed to seek medical attention if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

In case of accidental ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

Patients using this product should be aware that it is intended for external use only. Rare cases of serious burns have been reported with products of this type, highlighting the importance of adhering to the recommended usage guidelines.

It is advised to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or damaged skin. Additionally, concurrent use with other topical analgesics is not recommended, as this may increase the risk of adverse reactions.

Patients are instructed to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, or if symptoms clear up and then recur within a few days. Furthermore, individuals should seek medical advice if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

Drug Interactions

Concurrent use of this medication with other topical analgesics is contraindicated. The combination may increase the risk of adverse effects without providing additional therapeutic benefit. It is advised to avoid using multiple topical analgesics simultaneously to ensure patient safety and optimal therapeutic outcomes. Monitoring for any signs of increased local irritation or systemic effects is recommended if there is a concern about overlapping therapies.

Packaging & NDC

Below are the non-prescription pack sizes of Healthwise Menstrual Pain Relief Patch (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not use this medication if they are infants. For children aged 12 years and older, the application involves carefully removing the backing from the patch and applying the sticky side to the affected area. A single patch may be worn for up to 8-12 hours and can be repeated as necessary, not exceeding two applications per day.

For children under 12 years of age, it is advised to consult a physician before use. Additionally, this medication should be kept out of reach of children to prevent accidental exposure.

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 evaluated in these populations to ensure maternal and fetal safety.

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

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the product is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

It is important to note that this product is not intended for use in infants. Should an infant accidentally ingest the product, it is imperative to follow the same protocol: seek medical help or contact a Poison Control Center immediately. Prompt action is essential to ensure the safety and well-being of the individual affected by the overdosage.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

Rare cases of serious burns have been reported with products of this type. These events were identified through voluntary reporting and surveillance programs. The nature of these reports suggests a need for continued monitoring and evaluation of the safety profile of the product in the postmarketing setting.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, redness develops, irritation occurs, 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 signs of skin injury, such as pain, swelling, or blistering at the site of application.

When using this product, patients must be reminded to use it only as directed. They should be made aware that rare cases of serious burns have been reported with similar products. It is important to advise patients not to bandage the area tightly or use a heating pad in conjunction with the product. Patients should also be cautioned to avoid contact with the eyes and mucous membranes, and not to apply the product to wounds or damaged skin. Furthermore, patients should be informed that the product should not be used simultaneously with other topical analgesics.

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, ensuring that the temperature does not exceed 80°F (27ºC). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The route of administration for the medication is topical. For adults and children aged 12 years and older, the patch should be applied by carefully removing the backing and placing the sticky side on the affected area. Each patch can be worn for up to 8-12 hours and may be repeated as necessary, not exceeding two applications per day. After use, the patch should be properly discarded. For children under 12 years of age, consultation with a physician is advised.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is important to keep the medication out of reach of children and to avoid use on infants. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center (1-800-222-1222) is recommended.

Drug Information (PDF)

This file contains official product information for Healthwise Menstrual Pain Relief Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)