Rolaids Advanced Antacid Plus Anti-Gas

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of heartburn, sour stomach, acid indigestion, and upset stomach associated with these symptoms. Additionally, it is effective in alleviating pressure and bloating, commonly referred to as gas, that may accompany these gastrointestinal disturbances.

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

Dosage and Administration

Patients should chew 2 to 3 chews as symptoms occur, or as directed by a healthcare professional. It is important to follow the recommended dosage and not exceed the advised amount unless specifically instructed by a physician.

Contraindications

Use is contraindicated in patients who exceed the recommended dosage of more than 5 chews within a 24-hour period. Additionally, prolonged use at the maximum dosage for more than 2 weeks is contraindicated. Adherence to these guidelines is essential to prevent potential adverse effects associated with excessive intake.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

Patients are advised to consult with a healthcare provider, such as a doctor or pharmacist, prior to use if they are currently taking any prescription medications. This is particularly important as antacids may interact with certain prescription drugs, potentially affecting their efficacy or safety.

In terms of general precautions, it is imperative that patients do not exceed a maximum of five chews within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than two consecutive weeks to avoid potential adverse effects.

Currently, there are no specific laboratory tests recommended for monitoring the use of this product. However, healthcare professionals should remain vigilant for any signs of adverse reactions or interactions, particularly in patients taking concurrent medications.

In the absence of specific emergency medical help instructions or directives to stop taking the product, healthcare providers should exercise clinical judgment and consider individual patient circumstances when advising on the use of this product.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. It is important to adhere to the recommended guidelines, which include not exceeding five chews within a 24-hour period and avoiding the maximum dosage for more than two weeks.

In clinical trials and postmarketing experiences, there have been no specific adverse reactions reported; however, caution is advised. Patients should keep this product out of reach of children to prevent accidental ingestion, which could lead to serious consequences.

Monitoring for any unusual symptoms or reactions is recommended, and patients are encouraged to consult healthcare professionals if they experience any adverse effects or have concerns regarding the use of this product.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 Rolaids Advanced Antacid Plus Anti-Gas (calcium carbonate, simethicone and magnesium hydroxide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children. Prior to use, it is important to consult a doctor or pharmacist if the patient is currently taking any prescription medications, as antacids may interact with certain drugs.

For dosing, pediatric patients may chew 2-3 chews as symptoms occur, or as directed by a healthcare professional. The maximum dosage should not exceed 5 chews in a 24-hour period, and the maximum dosage should not be used for more than 2 weeks.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of Rolaids Advanced Antacid + Anti-Gas Soft Chews during pregnancy has not been established. Pregnant patients are advised to consult a healthcare provider prior to using this product, as there may be potential risks to the fetus; however, specific studies or data regarding these risks are not provided in the prescribing information.

While no specific dosage modifications for pregnant women are mentioned, caution is advised when considering the use of this product. Additionally, it is important to note that antacids may interact with certain prescription medications, which is particularly relevant for pregnant women who may be taking other drugs. Therefore, careful evaluation and consultation with a healthcare professional are recommended to ensure the safety of both the mother and the developing fetus.

Lactation

There are no specific warnings or recommendations regarding the use of Rolaids Advanced Antacid + Anti-Gas Soft Chews in lactating mothers. Additionally, there is no information available concerning the potential for excretion of this product in breast milk or any associated risks to breastfed infants.

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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, including airway management, oxygen supplementation, and intravenous fluids.

If the specific agent involved in the overdose is known, appropriate antidotes or specific treatments should be administered as indicated. Continuous monitoring of the patient’s condition is crucial, and healthcare providers should be prepared to manage complications that may arise during the course of treatment.

In all cases of suspected overdose, it is advisable to contact a poison control center or consult relevant clinical guidelines for further management recommendations.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to exceed a maximum of 5 chews within a 24-hour period to avoid potential overdose or adverse effects. Additionally, patients should be cautioned against using the maximum dosage for more than 2 weeks, as prolonged use may lead to complications.

Providers should encourage patients to consult with a doctor or pharmacist prior to use if they are currently taking any prescription medications. This is particularly crucial as antacids may interact with certain prescription drugs, which could affect the efficacy of the treatment or lead to unwanted side effects.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to inspect the foil packaging prior to use; do not utilize the product if the packaging is torn or damaged.

For optimal storage, the product should be maintained at room temperature, specifically within the range of 20° to 25°C (68° to 77°F). Proper handling and storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)