Careone Extra Strength

Description

CAREONE™ is an extra strength smooth antacid formulation containing Calcium Carbonate USP at a dosage of 750 mg per chewable tablet. The product is available in assorted fruit flavors and is packaged in a bottle containing 90 chewable tablets. It is gluten-free and is distributed by Foodhold U.S.A., LLC, located in Landover, MD 20785. The National Drug Code (NDC) for this product is 41520-905-90. This formulation is comparable to the active ingredient in TUMS® Smoothies™ EX, although it is not manufactured or distributed by GlaxoSmithKline, the distributor of TUMS® Smoothies™ EX. Quality is guaranteed or your money back, as stated by S&S Brands, LLC. For inquiries, customers can contact 1-877-846-9949.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to chew 2 to 4 tablets as symptoms occur, or as directed by a healthcare professional. It is important that the tablets are not swallowed whole.

Patients should not use this medication for symptoms that persist for more than 2 weeks without consulting a doctor.

Contraindications

Use of this product is contraindicated in the following situations:

• Patients should not exceed a dosage of 10 tablets within a 24-hour period.

• Pregnant individuals should not exceed 6 tablets in a 24-hour period.

• The maximum dosage should not be used for more than 2 weeks unless under the advice and supervision of a healthcare professional.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this medication.

General precautions must be strictly adhered to in order to ensure patient safety. It is imperative that patients do not exceed a maximum dosage of 10 tablets within a 24-hour period. For pregnant individuals, the dosage should not exceed 6 tablets in a 24-hour timeframe. Furthermore, the maximum dosage should not be utilized for more than 2 weeks unless specifically advised and monitored by a healthcare provider.

No laboratory tests have been specified for monitoring during the use of this medication. However, healthcare professionals should remain vigilant and assess the patient's overall health and response to treatment regularly.

In the absence of specific emergency medical help instructions or directives to discontinue use, healthcare providers are encouraged to maintain open communication with patients regarding any adverse effects or concerns that may arise during treatment.

Side Effects

Patients should be aware of potential adverse reactions associated with the use of this medication. While specific serious adverse reactions are not detailed, it is important to note that antacids may interact with certain prescription drugs, which could lead to unintended effects or diminished efficacy of the prescribed treatment.

Healthcare providers should monitor patients for any signs of adverse reactions and consider the potential for drug interactions when prescribing antacids alongside other medications. It is advisable for patients to inform their healthcare provider of all medications they are taking to mitigate the risk of adverse effects.

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 should be taken at least 2 hours apart from other drugs to ensure optimal therapeutic outcomes. Healthcare professionals should consider this timing when prescribing medications that may be affected by antacids.

Packaging & NDC

Below are the non-prescription pack sizes of Careone Extra Strength (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may chew 2-4 tablets as symptoms occur, or as directed by a healthcare professional. It is important to keep this medication out of reach of younger children to ensure safety.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients are advised not to exceed a dosage of 6 tablets within a 24-hour period. This precaution is essential to minimize potential risks to fetal outcomes. Healthcare professionals should counsel women of childbearing potential regarding the importance of adhering to this dosage limit during pregnancy to ensure the safety of both the mother and the developing fetus.

Lactation

There are no specific statements or information regarding nursing mothers or lactation in the provided drug insert for CAREONE EXTRA STRENGTH ASSORTED FRUITS calcium carbonate tablet, chewable. Therefore, the effects on lactating mothers and breastfed infants are not established. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. Regular monitoring of renal function tests is recommended for patients with known kidney problems. A reduced dose should be considered for patients with a creatinine clearance of less than 30 mL/min. Additionally, special monitoring is required for patients with severe renal 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 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 relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients not to exceed a maximum of 10 tablets within a 24-hour period. It is important to emphasize that if a patient is pregnant, they should limit their intake to no more than 6 tablets in a 24-hour period.

Additionally, healthcare providers should inform patients that the maximum dosage should not be used for more than 2 weeks unless specifically directed and supervised by a physician. This guidance is crucial to ensure patient safety and to prevent potential adverse effects associated with prolonged high-dose usage.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, ensuring that it is protected from extreme temperatures.

Additionally, the product features a safety seal; it is imperative that the product is not used if the printed seal under the cap is torn or missing, as this may indicate a breach in safety and quality.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients to consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs. Patients are instructed not to exceed 10 tablets within a 24-hour period, and pregnant individuals should limit their intake to no more than 6 tablets in the same timeframe. It is also important to note that the maximum dosage should not be used for more than 2 weeks unless under medical supervision, and patients should refrain from using the product for symptoms that persist beyond 2 weeks without consulting a doctor.

Drug Information (PDF)

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

View product document (PDF)