Dg Health 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 and is presented in a package containing 25 chewable tablets. This formulation provides complete acid reduction and is indicated for the relief of heartburn associated with acid indigestion. The product is comparable to the active ingredients found in Pepcid Complete®. The actual size of the tablet is designed for convenient consumption, allowing for effective relief with just one tablet.

Uses and Indications

This drug is indicated for the relief of heartburn associated with acid indigestion and sour stomach. It is intended for use in adults and pediatric patients as directed.

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 blood, or passing 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

Patients should be aware of the following warnings and precautions associated with 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 blood, or passing bloody or black stools, as these symptoms may indicate a serious underlying condition. In such cases, it is imperative to seek medical attention promptly. Additionally, this medication should not be used concurrently with other acid reducers.

Pre-Use Consultation Healthcare professionals should advise patients to consult a doctor prior to use 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 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 consultation include unexplained weight loss, nausea or vomiting, stomach pain, or a history of kidney disease.

Discontinuation of Use Patients should discontinue use and consult a healthcare provider if heartburn persists or worsens, or if the medication is required for more than 14 days.

Emergency Situations 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 individuals 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 with a history of heartburn lasting more than three months, or those experiencing heartburn accompanied by lightheadedness, sweating, or dizziness, should seek medical advice prior to using this medication. 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 also consult a healthcare provider. Frequent chest pain, wheezing (especially in conjunction with heartburn), unexplained weight loss, nausea, vomiting, stomach pain, or a history of kidney disease are further conditions that warrant medical consultation before use.

Common adverse reactions may include persistent heartburn or a worsening of symptoms. Patients are advised to stop using the medication and consult a doctor if their heartburn continues 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 should not be used in conjunction with other acid reducers, and individuals with known allergies to famotidine or other acid-reducing agents should avoid its use.

Drug Interactions

Antacids and acid-reducing agents may have significant interactions with various prescription medications. These interactions primarily arise from alterations in gastric pH, which can affect the solubility and absorption of certain drugs.

When co-administered with medications that require an acidic environment for optimal absorption, antacids and acid reducers may lead to reduced bioavailability of these drugs. It is advisable to monitor the therapeutic effects of such medications closely when used concurrently with antacids or acid reducers.

Healthcare professionals should consider recommending dosage adjustments or alternative therapies based on the specific prescription drugs involved and the clinical context. Regular assessment of patient response may be necessary to ensure therapeutic efficacy and safety.

Packaging & NDC

Below are the non-prescription pack sizes of Dg Health 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 prior to 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 before swallowing 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 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 potential 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 and symptomatic treatment, tailored to the specific symptoms presented. It is vital for healthcare providers to remain vigilant and prepared to implement necessary interventions based on the clinical presentation of the patient.

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 available in the insert text.

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 product 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 to stop using the product and seek medical advice if they find it necessary to take it for more than 14 days.

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

Lastly, healthcare providers should remind patients to consult a 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 a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at a controlled temperature range of 20-25°C (68-77°F) to ensure its stability and efficacy. Additionally, it is crucial to protect the product from moisture to maintain its integrity and prevent degradation. Proper handling and storage conditions are vital for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

Patients should be informed that the medication is administered orally. For adults and children aged 12 years and older, it is essential to chew the tablet completely before swallowing; the maximum dosage is two chewable tablets within a 24-hour period. For children under 12 years, consultation with a healthcare provider is recommended prior to use.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional before using the medication. It is also important for patients to read the directions and warnings on the label, as it contains critical information regarding the use of the product.

Drug Information (PDF)

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

View product document (PDF)