Acid Reducer Complete

Description

FAMOTIDINE 10 mg, CALCIUM CARBONATE 800 mg, and MAGNESIUM HYDROXIDE 165 mg are combined in a chewable tablet formulation designed for dual action as an acid reducer and antacid. Each tablet is flavored with berry to enhance palatability. The product is supplied in a container containing 50 chewable tablets, providing a convenient dosage form for effective gastrointestinal relief.

Uses and Indications

This drug is indicated for the relief of heartburn associated with acid indigestion and sour stomach.

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to chew the tablet completely before swallowing; the tablet should not be swallowed whole. For symptom relief, one tablet should be chewed prior to swallowing. The maximum recommended dosage is two 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 symptoms may indicate a serious underlying condition requiring medical evaluation. Additionally, concurrent use with other acid-reducing medications is contraindicated.

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 food, vomiting blood, or passing bloody or black stools, as these symptoms may indicate a serious underlying condition that requires immediate medical attention.

This medication should not be used concurrently with other acid reducers, as this may increase the risk of adverse effects.

Healthcare professionals are advised to counsel patients to seek medical advice prior to use if they have experienced heartburn for more than three months, as this may suggest a more serious condition. Additionally, patients should be instructed to consult a physician 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; or frequent wheezing, particularly in conjunction with heartburn. Unexplained weight loss, nausea or vomiting, stomach pain, or a history of kidney disease also warrant a discussion with a healthcare provider before initiating treatment.

Patients should discontinue use and consult a healthcare professional if heartburn persists or worsens, or if the medication is required 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, and those with known allergies to famotidine or other acid-reducing agents should avoid its use.

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 management of the patient's condition.

Packaging & NDC

Below are the non-prescription pack sizes of Acid Reducer Complete (famotidine, calcium carbonate and 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 before 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

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 important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 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 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. 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 to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and, if applicable, the administration of specific antidotes. Continuous evaluation of the patient's condition is necessary to address any complications that may arise during the management of an overdose.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified a range of adverse reactions reported voluntarily or through surveillance programs. These include headache, dizziness, diarrhea, constipation, nausea, and vomiting. Dermatological reactions such as rash and pruritus have also been noted. Serious allergic reactions, including anaphylaxis and angioedema, have been reported.

Hepatic events, such as hepatitis and elevated liver enzymes, along with renal impairment, have been observed. Cardiac arrhythmias, confusion, hallucinations, and depression, including instances of suicidal ideation, have been documented. Additionally, cases of pancreatitis and gastrointestinal bleeding have been reported.

Hematological events, including thrombocytopenia and agranulocytosis, have been noted, as well as interstitial nephritis. There have been reports of drug interactions with other medications that may lead to altered pharmacokinetics.

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. It is important to inform patients that they should not use this medication if they experience difficulty or pain when swallowing food, vomiting blood, or have bloody or black stools, as these symptoms may indicate a serious underlying condition that requires medical evaluation.

Patients should be cautioned against using this product in conjunction with other acid reducers, as this may lead to adverse effects. They should be instructed to discontinue use and consult a healthcare professional if their heartburn persists or worsens. Additionally, patients should be advised not to use this product for more than 14 days without consulting a doctor.

Healthcare providers should encourage patients to seek medical advice before using this medication if they have experienced heartburn for over three months, as this may signal a more serious condition. Patients should also be informed to consult a doctor 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 advised to seek medical guidance if they experience frequent 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 consult a healthcare professional prior to use.

Lastly, patients should be reminded to speak with their doctor or pharmacist before using this product 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 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 will help ensure the product remains effective and safe for use.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to consult a health professional if they are pregnant or breastfeeding prior to use. It is important for patients to read the directions and warnings provided, as well as the information contained on the bottle, to ensure safe and effective use.

Drug Information (PDF)

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

View product document (PDF)