Basic Care 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 as an antacid. Each tablet is flavored with berry to enhance palatability. The product is supplied in a container containing 50 chewable tablets, providing a convenient dosage form for patients requiring acid reduction and antacid therapy.

Uses and Indications

This drug is indicated for the relief of heartburn associated with acid indigestion and sour stomach. It effectively alleviates heartburn resulting from acid indigestion.

Limitations of Use: The safety and efficacy of this drug have not been established in populations outside of those experiencing heartburn due to acid indigestion.

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 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 not use this medication if they have a known allergy to famotidine or other acid reducers.

The use of this medication is contraindicated in individuals experiencing 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.

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. 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.

It is also important 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 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.

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: difficulty or pain when swallowing food, vomiting that includes blood, or the presence of bloody or black stools, as these may indicate a serious underlying condition.

In clinical practice, patients are cautioned against using this medication if they have a history of allergy to famotidine or other acid reducers. Additionally, it is recommended that individuals with certain pre-existing conditions consult a healthcare provider prior to use. These conditions include persistent heartburn lasting more than three months, heartburn accompanied by lightheadedness, sweating, or dizziness, and chest pain or shoulder pain that is associated with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders. Patients experiencing frequent chest pain, wheezing—especially in conjunction with heartburn, unexplained weight loss, nausea, vomiting, stomach pain, or those with kidney disease should also seek medical advice before using this product.

Common adverse reactions may include continued or worsening heartburn, which necessitates consultation with a healthcare provider. Furthermore, patients are advised not to use this medication for more than 14 days without medical guidance.

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 adjusting the timing of doses to minimize interaction risks. Specifically, it is recommended that antacids and acid reducers be administered at least two hours apart from other medications to reduce the likelihood of altered absorption. Regular monitoring of the patient's response to therapy is also suggested to ensure the effectiveness of the prescribed regimen.

Packaging & NDC

Below are the non-prescription pack sizes of Basic Care Dual Action Complete (famotidine, calcium carbonate and magnesium hydroxide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older are advised not to swallow the chewable tablet 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.

For children under 12 years of age, it is recommended to consult a healthcare professional before use.

Geriatric Use

There is no specific information available 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

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 timely medical support can significantly influence outcomes. 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.

Management procedures should include supportive care and symptomatic treatment as necessary. Healthcare providers are encouraged to follow established protocols for overdose management, which may involve decontamination, administration of antidotes if applicable, and continuous monitoring of vital signs and clinical status.

It is essential to document the circumstances of the overdose, including the substance involved, the amount taken, and the time of ingestion, to facilitate appropriate treatment and follow-up care.

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 compound in these areas.

Postmarketing Experience

No specific postmarketing experience details are available in the provided text. As such, there are no reported adverse events or case reports to summarize.

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. They 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.

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 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 encouraged to consult a doctor 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 quality and integrity during storage. Proper handling and storage conditions are vital for preserving the product's intended use and effectiveness.

Additional Clinical Information

The medication is administered orally, with specific instructions for different age groups. Adults and children aged 12 years and older should chew the tablet 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 professional advice if they are pregnant or breastfeeding. It is essential for patients to read the directions, warnings, and the bottle label, as these contain important information regarding the medication's use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

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