Dimethicone

Description

Simethicone Capsules contain 125 mg of simethicone per capsule. This product is supplied in a bulk quantity of 25,000 capsules, with the National Drug Code (NDC) number 53345-009-01. Upon receipt, immediate inspection is required to ensure product integrity. These capsules are intended solely for further manufacturing, processing, or repacking. It is essential to protect the capsules from heat, humidity, and light, and refrigeration is not recommended.

Uses and Indications

This drug is indicated for the relief of bloating, pressure, fullness, and the sensation of a stuffed feeling commonly associated with gas.

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

Dosage and Administration

Adults are advised to swallow 1 or 2 softgels with water as needed after meals or at bedtime. The maximum recommended dosage is 4 softgels per day, unless otherwise directed by a healthcare professional. It is important to adhere to this dosage to ensure safety and efficacy.

Contraindications

There are no contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if the condition persists.

Warnings and Precautions

Healthcare professionals should be aware of the following precautions when considering the use of this medication.

Pregnancy and Breastfeeding It is essential for individuals who are pregnant or breastfeeding to consult a healthcare professional prior to use. This precaution is critical to ensure the safety of both the mother and the child.

Emergency Situations In the event of an overdose, immediate medical assistance should be sought. Healthcare providers should advise patients to contact a Poison Control Center without delay to receive appropriate guidance and care.

Discontinuation of Use Patients are advised to discontinue use and consult a physician if their condition persists. This step is vital to reassess the treatment plan and ensure the patient's health and safety.

Side Effects

Patients should be advised to stop use and consult a healthcare professional if their condition persists. It is important for individuals who are pregnant or breastfeeding to seek guidance from a healthcare provider before using this product.

Additionally, the product should be kept out of reach of children to prevent accidental ingestion. In the event of an overdose, patients are urged to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Simethicone. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be monitored closely, and the medication must be kept out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center for guidance.

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, given the lack of targeted data for 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data 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

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 relation to this drug. 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 overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective 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 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 for patients to understand that if their condition persists despite using the medication, they should stop use and consult a doctor for further evaluation and guidance.

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 a controlled room temperature between 15° and 30°C (59° and 86°F). Care should be taken to protect the product from heat and moisture to maintain its integrity.

Additionally, the product should not be used if the imprinted safety seal under the cap is broken or missing, as this may indicate potential tampering or compromise of the product's safety. Proper handling and storage conditions are crucial to ensure the product remains effective and safe for use.

Additional Clinical Information

The medication is administered orally, with adults advised to swallow 1 or 2 softgels with water as needed after meals or at bedtime. Patients should not exceed a total of 4 softgels per day unless directed by a healthcare professional. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)