Antacid - Anti-Gas Relief

Description

Kroger Berry Antacid is formulated as a chewable tablet, available in a package containing 32 count. The product is designed to provide relief from heartburn and indigestion. It features a berry flavor to enhance palatability. The specific active ingredients and their concentrations are not detailed in the provided information.

Uses and Indications

This drug is indicated for the relief of heartburn, sour stomach, and acid indigestion. It is also effective in alleviating upset stomach associated with these symptoms. Additionally, this drug provides relief from bloating, pressure, or a stuffed feeling commonly referred to as gas.

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 and swallow 1 to 2 chewable tablets every 2 to 4 hours as needed for symptom relief. It is imperative that the total dosage does not exceed 5 chewable tablets within a 24-hour period.

For children under 12 years of age, it is recommended to consult a healthcare professional prior to administration to determine appropriate dosing and safety measures.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage of more than 5 chewable tablets within a 24-hour period or who utilize the maximum dosage for longer than 2 weeks without the advice and supervision of a physician.

Warnings and Precautions

The use of this product is contraindicated in individuals with a history of allergic reactions to the product or any of its components. Healthcare professionals should ensure that patients are aware of this critical warning to prevent adverse reactions.

Patients should be advised not to exceed a maximum of five chewable tablets within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than two weeks unless directed and monitored by a physician. This precaution is essential to mitigate the risk of potential side effects and ensure safe usage.

Constipation may occur as a side effect when using this product. Healthcare providers should inform patients about this possibility and recommend appropriate measures to manage or prevent constipation.

Before initiating treatment, it is imperative for patients to consult with a healthcare professional if they are currently taking any prescription medications. Antacids may interact with certain prescription drugs, and a thorough review of the patient's medication regimen is necessary to avoid potential drug interactions.

In the event of any adverse reactions or concerning symptoms, patients should seek immediate medical assistance. While specific instructions for emergency situations are not provided, it is essential for healthcare professionals to emphasize the importance of prompt medical attention when needed.

Side Effects

Patients should be aware that the use of this product is contraindicated in individuals who have a history of allergic reactions to the product or any of its ingredients. This warning is critical to prevent serious allergic responses that may occur upon administration.

In clinical trials and postmarketing experiences, no additional adverse reactions have been reported beyond those associated with allergic reactions. Therefore, careful screening for prior allergic history is essential before initiating treatment with this product to ensure patient safety.

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. Patients should be counseled to separate the dosing of antacids and other prescribed drugs by at least two hours when possible to ensure optimal therapeutic outcomes.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 12 years and older may chew and swallow 1 to 2 chewable tablets every 2 to 4 hours as needed, with a maximum of 5 chewable tablets in a 24-hour period. For children under 12 years of age, it is advised to consult a doctor before use.

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 adverse effects or changes in therapeutic response, 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 safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

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 an overdose, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may involve the following steps:

1. Assessment: Conduct a thorough evaluation of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide symptomatic treatment as necessary, which may include intravenous fluids, oxygen supplementation, or medications to stabilize the patient's condition.

3. Decontamination: If the overdose is recent and the patient is alert, activated charcoal may be administered to limit further absorption of the substance. However, this should be avoided in cases of altered mental status or risk of aspiration.

4. Consultation: Engage with a poison control center or toxicology specialist for guidance on specific antidotes or advanced interventions, if applicable.

Healthcare professionals should remain vigilant and prepared to implement these management strategies in the event of an overdose, despite the lack of specific information regarding the substance in question.

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 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 chewable tablets within a 24-hour period and to avoid using the maximum dosage for more than 2 weeks unless directed by a physician.

Patients should be made aware that the use of this product may lead to constipation. Additionally, healthcare providers should recommend that patients consult with a doctor or pharmacist before using this product if they are currently taking any prescription medications, as antacids may interact with certain drugs.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product in a dry place, maintaining a temperature range of 20° to 25°C (68° to 77°F) to ensure optimal stability and efficacy. Proper storage conditions are crucial for preserving the integrity 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 Antacid - Anti-Gas Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)