Acid Reducer Plus Antacid

Description

FAMOTIDINE 10 mg, CALCIUM CARBONATE 800 mg, and MAGNESIUM HYDROXIDE 165 mg are combined in a chewable tablet formulation designed for the reduction of gastric acid and to provide antacid effects. Each tablet is flavored with berry to enhance palatability. The product is supplied in a container containing 50 chewable tablets, facilitating convenient dosing.

Uses and Indications

This drug is indicated for the relief of heartburn associated with acid indigestion and sour stomach. It effectively alleviates heartburn resulting from acid indigestion.

Dosage and Administration

Adults and children aged 12 years and older are instructed to chew 1 tablet completely before swallowing to relieve symptoms. It is essential that the tablet is not swallowed whole. The maximum recommended dosage is 2 chewable tablets within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician before use.

Contraindications

Use is contraindicated in patients who experience difficulty or pain when swallowing food, vomiting with blood, or the presence of bloody or black stools, as these may indicate a serious underlying condition requiring medical evaluation. Additionally, concurrent use with other acid-reducing medications is contraindicated.

Warnings and Precautions

Patients should be advised of the following warnings and precautions prior to the use of this medication.

Allergy Alert This medication should not be used by individuals who are allergic to famotidine or other acid reducers.

Contraindications The medication is contraindicated in patients experiencing difficulty or pain when swallowing food, vomiting with blood, or the presence of bloody or black stools, as these symptoms may indicate a serious underlying condition. Such patients should seek medical attention promptly. Additionally, this medication should not be used concurrently with other acid reducers.

Pre-Use Consultation Healthcare professionals should recommend that patients consult a physician before using this medication if they have experienced heartburn for more than three months, as this may suggest a more serious condition. Patients should also seek medical advice if they experience heartburn accompanied by lightheadedness, sweating, or dizziness; chest pain or shoulder pain with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders; frequent chest pain; frequent wheezing, particularly in conjunction with heartburn; unexplained weight loss; nausea or vomiting; stomach pain; or have a history of kidney disease.

Discontinuation of Use Patients should be instructed to discontinue use and consult a healthcare provider if their heartburn persists or worsens, or if they find it necessary to use this product for more than 14 days.

Emergency Medical Assistance In the event of an overdose, patients should seek emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and patients are advised not to use the medication if they experience difficulty or pain when swallowing food, vomiting with blood, or the presence of bloody or black stools, as these symptoms may indicate a serious underlying condition that requires immediate medical attention.

Patients with a history of heartburn lasting more than three months, or those experiencing heartburn accompanied by lightheadedness, sweating, or dizziness, should consult a healthcare professional prior to use. Additionally, individuals presenting with chest pain or shoulder pain, particularly when accompanied by shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders, should seek medical advice. Frequent chest pain, wheezing (especially in conjunction with heartburn), unexplained weight loss, nausea, vomiting, stomach pain, or a history of kidney disease are also conditions that warrant consultation with a healthcare provider before using this medication.

Patients are advised to discontinue use and consult a doctor if their heartburn persists or worsens, or if they find it necessary to use the product for more than 14 days. Furthermore, individuals should not use this medication concurrently with other acid reducers, as this may increase the risk of adverse effects.

It is crucial for patients to remain vigilant regarding these potential adverse reactions and to seek medical guidance as necessary.

Drug Interactions

Antacids and acid reducers may interact with certain prescription medications, potentially affecting their absorption and efficacy. It is advisable to monitor the therapeutic effects of these medications when co-administered with antacids or acid-reducing agents.

Healthcare professionals should consider adjusting the timing of administration to minimize interaction effects. For instance, it may be beneficial to separate the dosing of antacids or acid reducers from the prescription medications to enhance their absorption and therapeutic outcomes. Regular assessment of the patient's response to therapy is recommended to ensure optimal treatment efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Acid Reducer Plus Antacid (famotidine, calcium carbonate and magnesium hydroxide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older are advised not to swallow the tablet whole; instead, they should chew the tablet completely before swallowing to effectively relieve symptoms. The maximum recommended dosage for this age group is 2 chewable tablets within a 24-hour period.

For children under 12 years of age, it is recommended to consult a doctor before use.

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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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 should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

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 specific postmarketing experience details are available in the extracted data. As such, there are no additional adverse events or rare case reports to summarize.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. Patients should be informed not to use the product if they experience difficulty or pain while swallowing food, vomiting blood, or passing bloody or black stools, as these symptoms may indicate a serious underlying condition that requires medical evaluation.

It is important to counsel patients against using this product in conjunction with other acid reducers. Providers should instruct patients to discontinue use and consult a doctor if their heartburn persists or worsens. Additionally, patients should be advised to stop using the product and seek medical advice if they find it necessary to take it for more than 14 days.

Patients should be encouraged to consult a doctor before using the product if they have experienced heartburn for over three months, as this may signal a more serious condition. They should also be advised to seek medical attention if they experience heartburn accompanied by lightheadedness, sweating, or dizziness, or if they have chest pain or shoulder pain along with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders.

Furthermore, patients should be instructed to consult a doctor if they frequently experience chest pain, wheezing (especially in conjunction with heartburn), unexplained weight loss, nausea, vomiting, or stomach pain. Those with a history of kidney disease should also be advised to seek medical guidance before using the product.

Lastly, healthcare providers should recommend that patients consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids and acid reducers may interact with certain drugs.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity. Additionally, it is essential to protect the product from moisture to ensure optimal quality and effectiveness. Proper handling and storage conditions are crucial for preserving the product's stability and efficacy.

Additional Clinical Information

The medication is administered orally, with specific instructions for different age groups. Adults and children aged 12 years and older should chew one tablet completely before swallowing, and should not exceed two chewable tablets within a 24-hour period. For children under 12 years, it is advised to consult a doctor prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Patients are also encouraged to read the directions and warnings carefully before use, keep the medication out of reach of children, and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose.

Drug Information (PDF)

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

View product document (PDF)