Good Sense Dual Action Complete

Description

No description information is available for the drug.

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 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 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 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 medication in the presence of certain symptoms, including difficulty or pain when swallowing food, vomiting that includes blood, or the presence of bloody or black stools. These symptoms may indicate a serious underlying condition, and patients should seek medical attention promptly.

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

Healthcare professionals should counsel 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. Additionally, patients should 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; stomach pain; or have a history of kidney disease.

Patients taking prescription medications should be advised to consult with a doctor or pharmacist before using this product, as antacids and acid reducers may interact with certain prescription drugs.

If heartburn persists or worsens, or if the patient requires this product for more than 14 days, they should discontinue use and consult a physician.

In the event of an overdose, immediate medical assistance should be sought, or the patient should 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 over 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 associated with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders, should 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 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 not use this medication in conjunction with other acid reducers, as this may increase the risk of adverse effects.

It is crucial for patients to remain vigilant regarding these potential adverse reactions and to seek medical advice when necessary to ensure their safety and well-being.

Drug Interactions

Antacids and acid reducers have the potential to interact with certain prescription medications. The mechanism of these interactions typically involves alterations in gastric pH, which can affect the solubility and absorption of various drugs.

Healthcare professionals should be aware of these interactions and consider monitoring patients for any changes in therapeutic efficacy or adverse effects when prescribing medications alongside antacids or acid reducers. Adjustments to dosages may be necessary based on the specific drugs involved and the clinical context.

Currently, there are no additional drug interactions or laboratory test interactions reported.

Packaging & NDC

Below are the non-prescription pack sizes of Good Sense Dual Action 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 children 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 alleviate symptoms, patients in this age group may chew 1 tablet prior to swallowing, with a maximum dosage of 2 chewable tablets within a 24-hour period.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for 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 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 help 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 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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. 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, or pain radiating to the arms, neck, or shoulders.

Furthermore, patients should be instructed to consult a doctor if they frequently experience chest pain or wheezing, particularly in conjunction with heartburn. They should also be advised to seek medical advice if they experience unexplained weight loss, nausea, vomiting, or stomach pain. Patients with a history of kidney disease should be encouraged to consult a doctor before using the product.

Lastly, healthcare providers should remind patients to speak with 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 packaging that ensures its integrity during storage. 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 handling and storage conditions are 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. To alleviate symptoms, patients should chew one tablet 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 on important safety information. Pregnant or breastfeeding individuals should seek advice from a healthcare professional before using the medication. It is essential to keep the product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Drug Information (PDF)

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

View product document (PDF)