Control Menstrual Cramp Relief

Description

No description information is available for the drug.

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 recommended dosage involves applying the product to the affected area. The application should be followed by a gentle massage into the skin until the product is thoroughly absorbed. This process may be repeated as necessary, with a maximum frequency of four times daily.

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

The product is intended for topical application, and the method of administration requires massaging the formulation into the skin. Care should be taken to adhere to the specified frequency to ensure safe and effective use.

Contraindications

The product is contraindicated for application to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, contact with eyes or mucous membranes should be avoided to prevent possible harm or discomfort.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, redness appears, or irritation develops.

In cases of ingestion, it is crucial to obtain emergency medical help or contact the Poison Control Center immediately.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days or clear up and recur within a few days, redness is present, or irritation develops. These precautions are essential to ensure patient safety and to address any potential adverse reactions effectively.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Control Menstrual Cramp Relief (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 before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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 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 no specific data available regarding 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients 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 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

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Monitoring of vital signs and laboratory parameters may be warranted to assess the patient's condition and guide further management.

Healthcare professionals should remain vigilant for potential symptoms that could indicate an overdosage scenario, although specific symptoms have not been detailed. If any adverse reactions or unexpected clinical presentations occur, appropriate medical intervention should be sought immediately.

For further guidance, healthcare providers are encouraged to consult local poison control centers or relevant medical authorities to obtain the most current recommendations for managing suspected overdosage cases.

Nonclinical Toxicology

The available nonclinical study data does not indicate any teratogenic or non-teratogenic effects. Additionally, there is no information provided regarding animal pharmacology and toxicology. As such, no specific findings related to carcinogenesis, mutagenesis, or impairment of fertility are available.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

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

Patients should be instructed to discontinue use and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, or if redness or irritation develops.

When using this product, patients must be reminded to follow the directions provided. They should avoid contact with the eyes and mucous membranes, and it is important not to apply the product to wounds or damaged skin.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its efficacy.

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 the Poison Control Center should be contacted without delay.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)