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 contains 10 mg of famotidine, an H2 receptor antagonist, along with 800 mg of calcium carbonate and 165 mg of magnesium hydroxide, which serve as antacids. The tablets are presented in a cool mint flavor and are packaged in a bottle containing 25 chewable tablets.

Uses and Indications

This drug is indicated for the relief of heartburn associated with acid indigestion and sour stomach. It is specifically effective in alleviating heartburn due to acid indigestion.

Dosage and Administration

Adults and children aged 12 years and over 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, 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 agents is contraindicated due to the potential for increased risk of adverse effects.

Warnings and Precautions

Use of this medication is contraindicated in individuals with a known allergy to famotidine or other acid-reducing agents.

Patients should refrain from using this medication if they experience difficulty or pain when swallowing, vomiting blood, or passing bloody or black stools, as these symptoms may indicate a serious underlying condition that requires immediate medical attention. Additionally, concurrent use with other acid reducers is not recommended.

Healthcare professionals should advise patients to consult a physician prior to use if they have experienced heartburn for more than three months, as this may suggest a more serious condition. Patients presenting with heartburn accompanied by lightheadedness, sweating, or dizziness, as well as those experiencing chest pain or shoulder pain with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders, should also 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 additional factors that warrant consultation with a healthcare provider before initiating treatment.

It is essential for patients to inform their healthcare provider or pharmacist if they are currently taking any prescription medications, as antacids and acid reducers may interact with certain drugs.

Patients should discontinue use and seek medical advice if their heartburn persists or worsens, or if they find it necessary to use this product for more than 14 days.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted 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 to discontinue use and consult a healthcare professional if they experience any of the following symptoms: 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.

Patients should also seek medical advice prior to using this medication if they have experienced heartburn for more than three months, as this may signal a more serious condition. Additional symptoms that warrant consultation include heartburn accompanied by lightheadedness, sweating, or dizziness; chest pain or shoulder pain accompanied by 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 a history of kidney disease.

Common adverse reactions may include persistent heartburn or worsening symptoms. Patients are advised to stop using the medication and consult a healthcare provider if their heartburn continues or worsens, or if they find it necessary to use the product for more than 14 days.

Additionally, patients should not use this medication in conjunction with other acid reducers, as this may increase the risk of adverse effects. An allergy alert is also in place; individuals with known allergies to famotidine or other acid reducers should refrain from using this product.

Drug Interactions

Antacids and acid-reducing agents may interact with various prescription medications, potentially affecting their absorption and therapeutic efficacy.

When co-administered with drugs that require an acidic environment for optimal absorption, antacids and acid reducers can lead to decreased bioavailability of these medications. It is advisable to monitor the clinical response of patients receiving such combinations and consider adjusting the timing of administration to minimize interaction.

Healthcare professionals should evaluate the necessity of dosage adjustments based on the specific medications involved and the clinical context of the patient. Regular assessment of therapeutic outcomes is recommended to ensure effective treatment while mitigating potential adverse interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. For adolescents and adults aged 12 years and older, it is important to note that the tablet should not be swallowed whole; it must be chewed completely to effectively relieve symptoms. The maximum recommended dosage for this age group is 2 chewable tablets within a 24-hour period.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information. Therefore, healthcare providers should exercise clinical judgment 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 variability in pharmacokinetics and pharmacodynamics that can occur with aging.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding 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 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 support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

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. As such, there are no additional adverse events or rare case reports to summarize at this time.

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. Patients should be instructed to discontinue use and consult a doctor if their heartburn persists or worsens. Additionally, they should be advised not to use the product for more than 14 days without medical guidance.

Patients should be encouraged to consult a healthcare professional 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 advice 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 informed 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 seek medical advice prior to use.

Lastly, patients should be encouraged to discuss their current medications with a healthcare provider or pharmacist before using this product, as antacids and acid reducers may interact with certain prescription drugs.

Storage and Handling

The product is supplied in packaging that ensures its integrity during storage and handling. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Additionally, it is essential to protect the product from moisture to prevent degradation. Proper adherence to these storage conditions is crucial for preserving the quality of the product.

Additional Clinical Information

The medication is administered orally, with specific instructions for different age groups. For adults and children aged 12 years and older, the tablet should not be swallowed whole; it must be chewed completely before swallowing, with a maximum of two chewable tablets allowed within a 24-hour period. For children under 12 years, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is also important for patients to read the directions and warnings provided, as well as the information on the bottle, which contains essential details regarding the medication.

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)