Lilas Period

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with menstrual cramps, lower pelvic pain, backache, leg cramps, sprains, and strains.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is to apply the patch 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 dry.

To apply the patch, open the pouch and remove the patch. Peel off the protective film and apply the sticky side directly to the affected area.

For children under 12 years of age, it is advised to consult a doctor before use.

Contraindications

Use of this product is contraindicated in the following situations:

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

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

Warnings and Precautions

This product is intended for external use only and should be utilized strictly as directed. It is contraindicated for application on wounds or damaged skin and should not be used in conjunction with a heating pad.

Healthcare professionals should advise patients to consult a physician prior to use if there is any redness present over the affected area. During application, it is crucial to avoid contact with the eyes, mucous membranes, and any rashes. Additionally, patients should refrain from tightly bandaging the treated area.

Patients must be instructed to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Furthermore, if any abnormal skin irritation occurs following application, medical consultation is recommended.

It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients should be aware that the product is intended for external use only and must be used strictly as directed. It is contraindicated for application on wounds or damaged skin and should not be used in conjunction with a heating pad. Prior to use, patients are advised to consult a healthcare professional if there is any redness over the affected area.

While using this product, it is essential to avoid contact with the eyes, mucous membranes, and any rashes. Patients should refrain from tightly bandaging the area of application. If the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use and seek medical advice. Additionally, if abnormal skin irritation occurs after usage, it is recommended to stop using the product and consult a healthcare provider.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. For adolescents and adults aged 12 years and older, the recommended application is to the affected area no more than twice daily.

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 should be aware that there are no specific safety concerns or dosage modifications associated with the use of this medication during pregnancy. Additionally, no special precautions regarding its use in pregnant individuals have been identified. As such, healthcare professionals should consider the absence of explicit risk data when advising women of childbearing potential about the use of this medication during pregnancy. It is advisable to weigh the potential benefits against any unknown risks when prescribing this medication to pregnant patients.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from 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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no additional adverse events or rare case reports to summarize.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the 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 patient safety and minimizing potential risks associated with accidental exposure.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place, away from direct sunlight to maintain its integrity. Additionally, the product must be protected from excessive moisture to ensure optimal quality and effectiveness. Proper handling and storage conditions are crucial for preserving the product's stability and efficacy.

Additional Clinical Information

The medication is administered via a topical route. Clinicians 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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)