Equate Acid Reducer Complete

Description

Famotidine 10 mg, Calcium Carbonate 800 mg, and Magnesium Hydroxide 165 mg are combined in a chewable tablet formulation. Each tablet is designed to provide a cool mint flavor, enhancing palatability. The product is packaged in a container containing 25 chewable tablets, suitable for oral administration.

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 drug.

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 agents is contraindicated due to the potential for increased risk of adverse effects.

Warnings and Precautions

Patients should be advised against the use of this medication if they have a known allergy to famotidine or other acid reducers.

It is imperative to refrain from using this product in the presence of specific symptoms, including difficulty or pain when swallowing, vomiting blood, or the presence of bloody or black stools, as these may indicate a serious underlying condition that requires immediate medical attention. Additionally, concurrent use with other acid reducers is contraindicated.

Healthcare professionals should 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. Patients should also be advised to consult a physician if they experience heartburn accompanied by lightheadedness, sweating, or dizziness; chest 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. Other concerning symptoms that warrant medical consultation include unexplained weight loss, nausea or vomiting, stomach pain, or a history of kidney disease.

Furthermore, 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 be instructed to 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 seek medical attention if they experience any of the following symptoms: difficulty or pain when swallowing, vomiting with blood, or the presence of bloody or black stools, as these may indicate a serious underlying condition.

Patients should not use this medication if they have a known allergy to famotidine or other acid reducers. Additionally, it is contraindicated for use in conjunction with other acid reducers.

Before using this medication, patients should consult a healthcare provider if they have experienced heartburn for more than three months, as this may signal a more serious condition. Other concerning symptoms that warrant medical consultation include 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 a history of kidney disease.

Patients are advised to discontinue use and consult a healthcare provider if their heartburn persists or worsens, or if they find it necessary to use the product for more than 14 days.

It is important to note that this medication may interact with certain prescription drugs, and patients taking other medications should discuss potential interactions with their healthcare provider.

Drug Interactions

Antacids and acid-reducing agents may interact with various prescription medications, potentially affecting their absorption and efficacy. It is advisable to monitor the timing of administration when these agents are used concurrently with other drugs.

For optimal therapeutic outcomes, healthcare professionals should consider advising patients to separate the administration of antacids or acid reducers from other medications by at least two hours. This precaution helps to minimize the risk of altered drug absorption and ensures that the prescribed medications maintain their intended effectiveness.

Packaging & NDC

Below are the non-prescription pack sizes of Equate Acid Reducer Complete (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 before use. For adolescents and adults aged 12 years and older, it is important to note that the tablet must not be swallowed whole; it should be chewed completely prior to swallowing 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 caution 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 general considerations for age-related physiological changes that may affect drug metabolism and clearance.

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 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 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, as symptoms may vary depending on the substance involved. It is essential for healthcare providers to assess the patient's condition thoroughly and initiate appropriate management procedures based on the clinical presentation and the specific agent involved in the overdose.

Monitoring and supportive care may be necessary, and healthcare professionals should be prepared to implement standard protocols for overdose management, including the administration of activated charcoal if indicated and the provision of symptomatic treatment as required.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

No specific postmarketing experience details have been reported. 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 when 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, pain radiating to the arms, neck, or shoulders, or lightheadedness.

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, which are essential for identification and ordering purposes. It is recommended to store the product at a controlled temperature range of 20-25°C (68-77°F). Care should be taken to protect the product from moisture to ensure its integrity and efficacy. Proper storage conditions are crucial for maintaining the quality of the product throughout its shelf life.

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 on the bottle, as it contains essential information regarding the medication's use.

Drug Information (PDF)

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

View product document (PDF)