Dual Action Complete

Description

Famotidine 10 mg, Calcium Carbonate 800 mg, and Magnesium Hydroxide 165 mg are combined in a chewable tablet dosage form. This formulation serves as an acid reducer and antacid. Each tablet is flavored with berry to enhance palatability. The product is packaged in a container containing 25 chewable tablets.

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 advised of the following warnings and precautions prior to 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 with blood, or the presence of bloody or black stools, as these symptoms may indicate a serious underlying condition. Patients exhibiting these symptoms should seek medical attention immediately. 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 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.

Drug Interactions Patients should be advised to consult a doctor or pharmacist before using this medication if they are currently taking any prescription drugs, as antacids and acid reducers may interact with certain medications.

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.

Emergency Situations In the event of an overdose, patients should seek emergency medical assistance or contact a Poison Control Center immediately 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: persistent or worsening heartburn, 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 over 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 associated with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders, should also consult a healthcare provider. Frequent chest pain, unexplained weight loss, nausea, vomiting, stomach pain, or a history of kidney disease are further conditions that warrant medical consultation before use.

It is important to note that this medication should not be used in conjunction with other acid reducers. Patients are advised to stop using the product and seek medical attention if their heartburn persists or worsens, or if they find it necessary to use the medication for more than 14 days.

An allergy alert is also in place; individuals should not use this medication if they are allergic to famotidine or other acid reducers.

Drug Interactions

Antacids and acid reducers may interact with certain prescription medications, potentially affecting their absorption and efficacy. It is advisable to monitor the timing of administration when these agents are used concurrently. Patients should be instructed to separate the dosing of antacids or acid reducers from the prescribed medications to minimize the risk of interaction.

Healthcare professionals should consider evaluating the need for dosage adjustments based on the specific medications involved and the clinical context of the patient. Regular monitoring of therapeutic outcomes may be warranted to ensure optimal efficacy of the prescribed treatment regimen.

Packaging & NDC

Below are the non-prescription pack sizes of 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 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

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 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 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 support 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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: headache, dizziness, constipation, diarrhea, and nausea. These events were 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. It is crucial to inform patients 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.

Patients should be cautioned against using this product in conjunction with other acid reducers. They must 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.

Healthcare providers should encourage patients 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. 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, pain radiating to the arms, neck, or shoulders, or lightheadedness.

Furthermore, patients should be advised 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 encouraged to seek medical advice prior to use.

Lastly, healthcare providers should remind patients to consult a doctor or pharmacist before using the 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 is 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 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 on the label, as it contains essential information regarding the medication's use.

Drug Information (PDF)

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

View product document (PDF)