Good Neighbor Pharmacy Dual Action Complete

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 formulated to deliver famotidine, a histamine H2-receptor antagonist, alongside calcium carbonate and magnesium hydroxide, which act 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.

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

Dosage and Administration

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

For children under 12 years of age, it is recommended to consult a physician for appropriate dosing and administration guidance.

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 in individuals with a known allergy to famotidine or other acid-reducing agents.

Contraindications The medication 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 that requires immediate medical attention. Additionally, this medication should not be used concurrently with other acid reducers.

Pre-Use Consultation Healthcare professionals should recommend that patients consult a doctor 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; or stomach pain.

Drug Interactions Patients currently taking prescription medications should consult a doctor or pharmacist prior to using this medication, as antacids may interact with certain prescription drugs.

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

Overdose Information In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center 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 product 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, pain radiating to the arms, neck, or shoulders, or lightheadedness, should seek medical advice. Frequent chest pain, wheezing (especially in conjunction with heartburn), unexplained weight loss, nausea, vomiting, or stomach pain 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 refrain from using this medication in conjunction with other acid reducers, as this may increase the risk of adverse effects.

It is crucial for patients to be vigilant about these potential reactions and to seek medical guidance when necessary to ensure their safety and well-being.

Drug Interactions

Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking any prescription drugs.

Antacids may have the potential to interact with specific prescription medications, which could alter the effectiveness of those drugs. It is important for patients to disclose all medications they are taking to ensure safe and effective use of antacids. Monitoring for any adverse effects or changes in therapeutic outcomes is recommended when antacids are used concurrently with prescription medications.

Packaging & NDC

Below are the non-prescription pack sizes of Good Neighbor Pharmacy Dual Action 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 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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and may need to implement specific protocols based on the substance taken. Continuous assessment and monitoring of vital signs are recommended to guide further treatment decisions.

In summary, prompt action and appropriate medical intervention are vital in the management of overdose cases to mitigate potential complications and ensure patient safety.

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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: headache, dizziness, constipation, diarrhea, and nausea. These events have been documented in the context of routine pharmacovigilance activities.

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, 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 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. Lastly, patients should be advised to speak with a doctor or pharmacist before using the product if they are currently taking any prescription medications, as antacids may interact with certain drugs.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25˚C (68-77˚F) to ensure optimal stability and efficacy. Additionally, it is essential to protect the product from moisture to maintain its integrity. Proper handling and storage conditions are crucial 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 recommended dosage is two chewable tablets within a 24-hour period. For children under 12 years, consultation with a healthcare provider is advised prior to use.

Clinicians should counsel patients who are pregnant or breastfeeding to seek advice from a health professional before using the medication. It is also important for patients to read the directions, warnings, and the bottle label, as these contain critical information regarding the safe use of the product.

Drug Information (PDF)

This file contains official product information for Good Neighbor Pharmacy Dual Action Complete, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)