Anti-Gas

Description

This product is an ultra-strength antiflatulent designed to provide relief from bloating, pressure, discomfort, and gas. It is presented in softgel dosage form. The product is comparable to the active ingredient in Phazyme® Ultra Strength. It is important to note that this product is not manufactured or distributed by C.B. Fleet Company Inc., the distributor of Phazyme® Ultra Strength. The packaging includes a tamper-evident safety seal; do not use if the seal under the cap is broken or missing. For complete warnings and product information, retain the outer carton. This product is distributed by Valu Merchandisers, Co., located at 5000 Kansas Ave, Kansas City, KS 66106.

Uses and Indications

This drug is indicated for the relief of bloating, pressure, or fullness commonly referred to as gas.

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

Dosage and Administration

Patients should swallow one or two softgels as needed after meals. The maximum recommended dosage is two softgels within a 24-hour period, unless otherwise directed by a physician. It is important for healthcare professionals to advise patients not to exceed this dosage without medical supervision.

Contraindications

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

Warnings and Precautions

Patients should discontinue use and consult a healthcare professional if their condition does not improve.

In the context of general precautions, it is advised that individuals who are pregnant or breastfeeding seek guidance from a healthcare provider prior to using this product.

No specific laboratory tests or emergency medical help instructions are provided in the insert; therefore, healthcare professionals should exercise clinical judgment when considering the need for monitoring or intervention based on individual patient circumstances.

Side Effects

Patients should be advised to stop use and consult a doctor if their condition persists. It is important for individuals who are pregnant or breastfeeding to seek guidance from a health professional prior to using this product. Additionally, the product should be kept out of reach of children to ensure safety.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Anti-Gas (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. Safety and efficacy in pediatric populations have not been established, and caution is advised when administering this medication to children.

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, given the lack of targeted data.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 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 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

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management for potential overdose situations.

It is essential to monitor patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, contacting a poison control center or a medical toxicologist for guidance on specific management strategies is advisable. Additionally, healthcare professionals should be prepared to implement advanced life support measures if the patient's condition warrants such intervention.

Documentation of the incident, including the amount and timing of the substance involved, is crucial for ongoing management and treatment decisions.

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, they should stop using the medication and consult a doctor for further evaluation and guidance. This ensures that patients are aware of the necessary steps to take should their symptoms not improve, promoting safe and effective use of the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 15-30ºC (59-86ºF). Care should be taken to protect the product from heat and moisture to ensure its integrity and efficacy. Proper storage conditions are crucial for maintaining the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)