Injoy Heartburn Relief

Description

Famotidine 10 mg, Calcium Carbonate 800 mg, and Magnesium Hydroxide 165 mg are combined in a chewable tablet formulation designed for dual action as an acid reducer and antacid. Each tablet is flavored with berry to enhance palatability. The product is supplied in a package 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 specifically effective in alleviating 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 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. Patients exhibiting these symptoms should 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. 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; stomach pain; or if they have a history of kidney disease.

Drug Interactions Patients taking prescription medications should consult with their doctor or pharmacist before using this product, as antacids and acid reducers may interact with certain prescription 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 that includes 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 accompanied by shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders; frequent chest pain; and frequent wheezing, particularly in conjunction with heartburn. Unexplained weight loss, nausea or vomiting, stomach pain, and a history of kidney disease are also important considerations that should prompt a discussion with a healthcare provider before use.

Common adverse reactions may include persistent heartburn that continues or worsens, as well as the need to use this product for more than 14 days. Patients are advised to stop use and consult a doctor under these circumstances. Additionally, individuals with known allergies to famotidine or other acid reducers should avoid using this medication, as an allergic reaction may occur. It is also recommended that this medication not be used in conjunction with other acid reducers.

Drug Interactions

Antacids and acid-reducing agents may interact with various prescription medications, potentially affecting their absorption and therapeutic efficacy.

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 clinical response of patients receiving such combinations closely.

Healthcare professionals should consider adjusting the timing of administration between antacids or acid reducers and the affected prescription drugs to minimize interaction risks. In some cases, dosage adjustments may be necessary based on the specific medications involved and the clinical context.

Packaging & NDC

Below are the non-prescription pack sizes of Injoy Heartburn Relief (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 prior to use. For adolescents and adults aged 12 years and older, it is important to note that the tablet should not be swallowed whole; it must be chewed completely 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 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 healthcare professional prior to using this medication. There is no specific data available 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 symptoms may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Continuous monitoring of the patient's vital signs and clinical status is recommended to ensure safety and efficacy in treatment.

Healthcare providers are encouraged to remain vigilant and proactive in addressing potential overdose cases to mitigate risks and enhance patient outcomes.

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 question.

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. 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 medical condition that requires a doctor's 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 healthcare professional 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 healthcare professional 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 before using this product.

Lastly, healthcare providers should remind patients to consult a doctor or pharmacist prior to use 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. 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 advice from a health professional if they are pregnant or breastfeeding. It is also important for patients to read the directions, warnings, and the bottle label, as these contain essential information regarding the medication's use.

Drug Information (PDF)

This file contains official product information for Injoy Heartburn Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)