Calcium Carbonate 10 Gr (648 mg)

Description

Rugby® Calcium Carbonate is an antacid formulation containing calcium carbonate as the active ingredient. Each tablet provides 10 grams (648 mg) of calcium carbonate. The product is packaged in a container containing 1000 tablets. The National Drug Code (NDC) for this product is 0536-1206-10.

Uses and Indications

This drug is indicated for the relief of acid indigestion, heartburn, sour stomach, and upset stomach associated with these symptoms.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients are advised to take one to four tablets daily, ensuring that the total dosage does not exceed four tablets within a 24-hour period. It is important to note that the maximum dosage should not be utilized for more than two consecutive weeks. Healthcare professionals should monitor patients for adherence to these guidelines to prevent potential adverse effects associated with prolonged maximum dosage usage.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if symptoms persist for more than two weeks.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have a history of kidney stones or are adhering to a calcium-restricted diet. These conditions may influence the safety and efficacy of the treatment.

It is advisable for patients to seek guidance from a doctor or pharmacist before initiating use, particularly if they are currently taking any prescription medications. Antacids have the potential to interact with certain prescription drugs, which may necessitate careful monitoring and adjustment of therapy.

Patients are instructed to discontinue use and contact their healthcare provider if symptoms persist for more than two weeks. Prolonged symptoms may indicate an underlying condition that requires further evaluation and management.

Emergency medical assistance should be sought if any severe adverse reactions occur, although specific instructions for such situations were not provided in the available information.

Side Effects

Patients should be aware of certain warnings associated with the use of this product. It is advised to consult a doctor prior to use if there is a history of kidney stones or if the patient is on a calcium-restricted diet.

In the event that symptoms persist for more than two weeks, patients are instructed to discontinue use and seek medical advice. Additionally, pregnant or breastfeeding individuals should consult a health professional before using this product to ensure safety for both the mother and child.

It is crucial to keep this product out of reach of children to prevent accidental ingestion or misuse.

Drug Interactions

Antacids may interact with various prescription medications, potentially affecting their absorption and efficacy. It is advisable to monitor the timing of antacid administration in relation to other medications to minimize these interactions. Specifically, antacids can alter the gastric pH, which may impact the solubility and subsequent absorption of certain drugs.

Healthcare professionals should consider advising patients to separate the administration of antacids and other medications by at least two hours to reduce the risk of interaction. Regular assessment of therapeutic outcomes may be warranted to ensure the effectiveness of the prescribed therapy when antacids are used concurrently.

Packaging & NDC

Below are the non-prescription pack sizes of Calcium Carbonate 10 Gr (648 mg) (calcium carbonate 10gr (648 mg)). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. It is important to note that this product is supplied in a bulk package. Therefore, healthcare professionals should ensure that the contents are dispensed with a child-resistant closure and stored in a tight, light-resistant container, as defined by the United States Pharmacopeia (USP).

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 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 medication 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 if they have kidney stones or are on a calcium-restricted diet. These conditions may necessitate careful consideration of dosing adjustments and monitoring to ensure safe and effective use of the medication in individuals with reduced kidney function.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and interventions tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective 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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Patients should be informed to discontinue use and consult a doctor if their symptoms persist for more than two weeks, as this may indicate a need for further evaluation.

It is important for healthcare providers to encourage patients to seek medical advice before using the medication if they have a history of kidney stones or are on a calcium-restricted diet. These conditions may affect the safety and efficacy of the treatment.

Additionally, patients should be counseled to consult with their doctor or pharmacist prior to use if they are currently taking any prescription medications. This is crucial as antacids may interact with certain prescription drugs, potentially leading to adverse effects or reduced effectiveness of the medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended dosage of one to four tablets daily. It is important not to exceed four tablets within a 24-hour period and to avoid using the maximum dosage for more than two weeks.

Clinicians should counsel patients to consult a doctor before use if they have kidney stones or are on a calcium-restricted diet. Additionally, patients taking prescription medications should seek advice from a healthcare professional, as antacids may interact with certain drugs. Patients are advised to discontinue use and consult a doctor if symptoms persist beyond two weeks. Pregnant or breastfeeding individuals should also seek professional guidance before use, and the medication should be kept out of reach of children.

Drug Information (PDF)

This file contains official product information for Calcium Carbonate 10 Gr (648 mg), including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)