Careone Acid Reducer Complete

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 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 with blood, or the presence of 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 be consulted prior to use if the patient has experienced heartburn for more than three months, as this may suggest a more serious condition. Other symptoms warranting consultation include 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 a history of kidney disease.

Drug Interactions Patients should inform their healthcare provider or pharmacist if they are taking any prescription medications, as antacids and acid reducers may interact with certain drugs.

Monitoring and Discontinuation Patients are advised to discontinue use and consult a healthcare professional 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 patients 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 should also seek medical advice prior to using this medication if they have experienced heartburn for more than three months, as this may signal a more serious condition. Additional symptoms that warrant consultation include 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 a history of kidney disease.

Common adverse reactions may include persistent heartburn or worsening symptoms. Patients are advised to stop using the medication and consult a healthcare provider if their heartburn continues or worsens, or if they find it necessary to use the product for more than 14 days.

Additionally, patients should not use this medication in conjunction with other acid reducers, as this may increase the risk of adverse effects. An allergy alert is also noted; individuals with a known allergy to famotidine or other acid reducers should refrain from using this product.

Drug Interactions

Antacids and acid reducers may interact with various prescription medications, potentially affecting their efficacy and absorption.

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

Healthcare professionals should consider adjusting the timing of administration to minimize interaction risks, such as spacing the doses of antacids or acid reducers and the affected prescription drugs. Regular assessment of the patient's response to therapy is recommended to ensure optimal treatment outcomes.

Packaging & NDC

Below are the non-prescription pack sizes of Careone Acid Reducer 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 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

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. 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 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 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 are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation.

Prompt intervention is crucial in mitigating potential adverse effects associated with an overdose. Symptoms 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 and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and effective recovery.

Nonclinical Toxicology

No teratogenic effects were reported in the studies conducted. Additionally, there was no increase in fetal malformations observed, indicating a lack of non-teratogenic effects.

Information regarding nonclinical toxicology and animal pharmacology and toxicology was not provided in the insert.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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 this medication 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, as this may lead to adverse effects. They should be instructed to discontinue use and consult a doctor if their heartburn persists or worsens. Additionally, patients should be advised not to use this product for more than 14 days without consulting a healthcare professional.

Healthcare providers should encourage patients to seek medical advice before using this medication if they have experienced heartburn for over three months, as this may signal a more serious condition. Patients should also be informed to consult a doctor if they experience heartburn accompanied by lightheadedness, sweating, or dizziness, as well as if they have chest pain or shoulder pain with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders.

Furthermore, patients should be advised to seek medical consultation 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 consult a healthcare provider before use.

Lastly, patients should be reminded to discuss their current medications with their doctor or pharmacist, as antacids and acid reducers may interact with certain prescription 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

Patients should consult a health professional prior to use if they are pregnant, breastfeeding, or taking a prescription drug, as antacids and acid reducers may interact with certain medications. No further information is available regarding laboratory tests, abuse potential, route, method, and frequency of administration, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)