Tums Chewy Bites with Gas Relief

Description

TUMS with Gas Relief is a formulation consisting of active ingredients calcium carbonate and simethicone. This product is presented in the form of chewy bites, designed to provide relief from heartburn, acid indigestion, upset stomach, and bloating and gas. The product is available in a dual flavor profile of lemon and strawberry. Each package contains 54 chewable tablets, facilitating convenient dosing.

Uses and Indications

This drug is indicated for the relief of heartburn, acid indigestion, and sour stomach. It is also effective in alleviating upset stomach associated with these symptoms, as well as gas related to heartburn, sour stomach, or acid indigestion.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to chew 1 to 2 tablets as symptoms occur, or as directed by a healthcare professional. It is essential that the tablets are chewed or crushed completely before swallowing to ensure proper absorption.

Patients should not use this medication for symptoms that persist for more than 2 weeks unless advised by a healthcare provider.

Contraindications

Use of this product is contraindicated in the following situations:

• Administration of more than 6 tablets within a 24-hour period is prohibited due to the risk of adverse effects associated with excessive dosage.

• Pregnant individuals should not exceed 6 tablets in a 24-hour period to avoid potential harm to the fetus.

• The maximum dosage should not be utilized for more than 2 weeks unless under the guidance and supervision of a healthcare professional, to mitigate the risk of complications associated with prolonged high-dose use.

Warnings and Precautions

Healthcare professionals should advise patients to consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs.

It is crucial to adhere to the recommended dosage guidelines. Patients should not exceed 6 tablets within a 24-hour period. This limit applies equally to pregnant individuals, who should also refrain from taking more than 6 tablets in a 24-hour timeframe. Furthermore, the maximum dosage should not be utilized for more than 2 weeks unless directed and monitored by a healthcare provider.

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

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. It is important to consult a doctor or pharmacist before use, especially if currently taking a prescription drug, as antacids may interact with certain medications.

When using this product, patients are advised not to exceed a maximum dosage of 6 tablets within a 24-hour period. Additionally, pregnant individuals should adhere to the same maximum dosage limit. Prolonged use of the maximum dosage for more than 2 weeks should only occur under the guidance and supervision of a healthcare professional.

To ensure safety, this product should be kept out of reach of children.

Drug Interactions

Antacids may interact with various prescription medications, potentially affecting their absorption and efficacy. It is advisable to monitor the timing of antacid administration in relation to other medications to minimize these interactions. Specifically, antacids should be taken at least 2 hours apart from other drugs to ensure optimal therapeutic effects. Healthcare professionals should consider this timing when prescribing medications that may be affected by antacids.

Packaging & NDC

Below are the non-prescription pack sizes of Tums Chewy Bites with Gas Relief (calcium carbonate and simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may chew 1-2 tablets as symptoms occur, or as directed by a healthcare professional. It is important that the tablets are chewed or crushed completely before swallowing to ensure proper administration.

Care should be taken to keep the medication out of reach of younger children to prevent accidental ingestion.

Geriatric Use

There is no specific information regarding the use of TUMS Chewy Bites with Gas Relief in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to geriatric patients. Monitoring for efficacy and potential adverse effects may be warranted in this population, given the absence of specific data.

Pregnancy

Pregnant patients should not exceed a dosage of 6 tablets within a 24-hour period. Additionally, the maximum dosage should not be used for more than 2 weeks unless advised and supervised by a healthcare professional. It is important for healthcare providers to consider these recommendations when prescribing this medication to pregnant patients, as exceeding the recommended dosage may pose risks to fetal outcomes. Careful monitoring and consultation with a physician are advised to ensure the safety of both the mother and the developing fetus.

Lactation

There are no specific warnings or recommendations regarding the use of TUMS Chewy Bites with Gas Relief 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 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 overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. The maximum allowable dosage is six tablets within a 24-hour period. This limit applies equally to pregnant individuals, who should also refrain from exceeding six tablets in the same timeframe.

Prolonged use of the maximum dosage is not advised. Healthcare professionals should counsel patients to avoid using the maximum dosage for more than two weeks unless specifically directed and monitored by a physician.

In cases of suspected overdosage, it is essential to seek immediate medical attention. Symptoms of overdosage may vary and should be assessed by a healthcare professional. Management procedures will depend on the severity of the symptoms and may include supportive care and symptomatic treatment as necessary.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients not to exceed a maximum of 6 tablets within a 24-hour period. It is important to emphasize that this limit applies equally to pregnant patients, who should also refrain from taking more than 6 tablets in a 24-hour timeframe.

Additionally, healthcare providers should inform patients that the maximum dosage should not be used for more than 2 weeks unless specifically directed and monitored by a physician. This guidance is crucial to ensure patient safety and to prevent potential adverse effects associated with prolonged high-dose usage.

Storage and Handling

The product is supplied in a safety-sealed container. It is imperative that the product is not stored above 25°C (77°F) to maintain its integrity and efficacy. Users should ensure that the printed inner seal beneath the cap is intact; the product should not be used if this seal is missing or broken. Proper handling and storage conditions are essential to ensure the product remains safe for use.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs. Patients are also cautioned not to use the medication for symptoms that persist for more than two weeks without medical advice.

Drug Information (PDF)

This file contains official product information for Tums Chewy Bites with Gas Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)