Heb Extra Strength Antacid

Description

NDC# 37808-701-10. This product is an extra strength antacid tablet formulated to provide relief from heartburn and gas. Each chewable tablet contains calcium carbonate and magnesium hydroxide as active ingredients, along with simethicone for anti-gas properties. The tablets are flavored with berry and are packaged in a bottle containing 100 chewable tablets. Manufactured with pride and care for H-E-B® in San Antonio, TX 78204, this product is tamper evident; do not use if the printed inner seal is broken or missing. This formulation is comparable to the active ingredients found in Rolaids® Multi-Symptoms. The product is backed by a 100% guarantee. This product is not manufactured or distributed by Chattem Inc., the owner of the registered trademark Multi-Symptoms ROLAIDS®.

Uses and Indications

This drug is indicated for the relief of heartburn, acid indigestion, and the pressure, bloating, and discomfort commonly referred to as gas.

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

Dosage and Administration

Patients should chew 2 to 4 tablets completely as symptoms occur or as directed by a healthcare professional. It is important to follow the recommended dosage and not exceed the maximum dosage unless advised by a physician.

Contraindications

There are no specific contraindications identified for this product. However, it is advised that patients do not exceed a maximum dosage of 8 tablets within a 24-hour period. Additionally, the maximum dosage should not be used for more than 2 weeks to mitigate potential risks associated with prolonged use.

Warnings and Precautions

Healthcare professionals should advise patients to consult with 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 8 tablets within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than 2 weeks to avoid potential adverse effects.

Currently, there are no laboratory tests required or suggested for the safe use of this medication. Therefore, routine monitoring through laboratory assessments is not necessary.

In the absence of specific instructions regarding emergency medical assistance or the need to discontinue use and contact a healthcare provider, practitioners should remain vigilant and encourage patients to report any unusual symptoms or concerns during treatment.

Side Effects

Patients should be advised to consult a doctor or pharmacist prior to using this product if they are currently taking any prescription medications, as antacids may interact with certain prescription drugs.

When using this product, it is important for patients to adhere to the recommended dosage guidelines. Specifically, patients should not exceed 8 tablets within a 24-hour period and should refrain from using the maximum dosage for more than 2 weeks.

Additionally, this product should be kept out of reach of children to prevent accidental ingestion.

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 Heb Extra Strength Antacid (calcium carbonate, magnesium hydroxide, 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. For symptomatic relief, children may chew 2-4 tablets completely as needed or as directed by a healthcare professional.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use, 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 individuals are mentioned, caution is advised. It is recommended that the use of this product be discussed with a healthcare professional if pregnancy is confirmed or anticipated.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion 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 event of overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. The maximum allowable dosage is 8 tablets within a 24-hour period. Exceeding this limit may lead to serious health complications.

Healthcare professionals should be aware that the maximum dosage should not be utilized for more than 2 weeks. Prolonged use at this level increases the risk of toxicity and other associated health risks.

In cases of suspected overdosage, immediate medical attention is advised. Symptoms may vary depending on the specific circumstances and the individual’s health status. Management procedures should include supportive care and symptomatic treatment as necessary. Monitoring of the patient’s condition is essential to address any complications that may arise from the overdosage.

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 provided data.

Patient Counseling

Healthcare providers should advise patients not to exceed a maximum of 8 tablets within a 24-hour period. It is important to communicate that the maximum dosage should not be used for more than 2 weeks to avoid potential complications.

Additionally, patients should be encouraged to consult with their 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 lead to adverse effects or reduced efficacy of the medications.

Storage and Handling

The product is supplied in a configuration that ensures tamper evidence; it should not be used if the printed inner seal is broken or missing.

Storage conditions require the product to be kept at room temperature, with a specific emphasis on avoiding high humidity to maintain product integrity. Proper handling is essential to ensure the safety and efficacy of the product.

Additional Clinical Information

Patients should be advised that the medication is administered orally, with a recommended dosage of 2-4 tablets to be chewed completely as symptoms occur or as directed by a healthcare professional. Clinicians should counsel 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. Additionally, it is important to keep the medication out of reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)