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Care One Gas Relief

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Active ingredient
Dimethicone 180 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2004
Label revision date
September 15, 2024
Active ingredient
Dimethicone 180 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2004
Label revision date
September 15, 2024
Manufacturer
American Sales Company
Registration number
M002
NDC root
41520-657

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Drug Overview

CAREone® is an over-the-counter medication that provides ultra-strength relief from gas discomfort, pressure, and bloating. Its active ingredient, simethicone (a medication that helps break up gas bubbles in the stomach and intestines), works quickly to alleviate feelings of fullness and pressure commonly associated with gas.

This product is designed to be easy to swallow and is gluten-free, making it accessible for many individuals seeking relief from uncomfortable gas symptoms. Each package contains 60 softgels, ensuring you have an ample supply for when you need it.

Uses

If you're experiencing bloating, pressure, or a feeling of fullness often associated with gas, this medication can help relieve those uncomfortable symptoms. It provides fast relief from gas discomfort, allowing you to feel more at ease.

You can trust that this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus. This makes it a safer option for those who may be pregnant or planning to become pregnant.

Dosage and Administration

You can take one or two softgels after a meal when you need them. It's important not to take more than two softgels in a single day unless your doctor has advised you to do so and is supervising your use of the medication. Always follow this guidance to ensure your safety and the effectiveness of the treatment.

What to Avoid

It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications or concerns about abuse, misuse, or dependence (which means relying on a substance in a harmful way), you should stop using the medication and consult your doctor if your condition does not improve. Always prioritize your health and safety by following these instructions closely.

Side Effects

If you experience any persistent symptoms while using this medication, it's important to stop using it and consult your doctor. Additionally, please ensure that this medication is kept out of reach of children to prevent accidental ingestion.

Warnings and Precautions

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you find that your condition does not improve or continues to persist, please stop taking the medication and consult your doctor for further guidance.

Always prioritize your health and safety by following these precautions. If you have any concerns or experience unusual symptoms, don’t hesitate to reach out to your healthcare provider.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

When it comes to using CARE ONE GAS RELIEF (simethicone) during pregnancy, there is no specific information available regarding its safety, dosage adjustments, or any special precautions you should take. This means that the drug insert does not provide guidance on how this medication may affect you or your developing baby.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before taking any medication, including over-the-counter products like simethicone. They can help you weigh the potential benefits and risks based on your individual health needs.

Lactation Use

If you are breastfeeding and considering using CARE ONE GAS RELIEF (simethicone), it's important to note that the drug insert does not provide specific information about its use during nursing. This means there are no established guidelines or known effects on milk production or your nursing infant.

As always, it's best to consult with your healthcare provider before taking any medication while breastfeeding to ensure it is safe for you and your baby.

Pediatric Use

It's important to keep this medication out of reach of children. This precaution helps prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it, ensuring their safety at all times. If you have any concerns or questions about the medication, don't hesitate to reach out to your healthcare provider for guidance.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that healthcare providers may not have tailored guidelines for elderly patients, which can be important given the unique health considerations that often come with aging.

If you or a loved one is an older adult considering this medication, it’s essential to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions and share any concerns you may have about your medications or tests.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a temperature between 68°F and 77°F (20°C to 25°C). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to do so with clean hands and in a sterile field (a clean area free from germs) to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You can take this medication orally by swallowing one or two softgels after a meal, as needed. It's important not to exceed two softgels in a day unless your doctor advises otherwise. Always follow your healthcare provider's guidance to ensure safe and effective use.

FAQ

What is CAREone®?

CAREone® is an ultra strength gas relief medication that contains simethicone 180 mg, designed to relieve bloating, pressure, and fullness commonly referred to as gas.

How should I take CAREone®?

You should swallow one or two softgels as needed after a meal, but do not exceed two softgels per day unless advised by a physician.

What are the indications for using CAREone®?

CAREone® is indicated for the relief of bloating, pressure, and discomfort associated with gas.

Are there any contraindications for CAREone®?

There are no contraindications listed for CAREone®.

What should I do if my condition persists?

If your condition persists, you should stop using CAREone® and consult a doctor.

Is CAREone® safe to use during pregnancy or while nursing?

The drug insert does not provide specific information regarding the use of CAREone® during pregnancy or lactation.

What are the storage instructions for CAREone®?

Store CAREone® at a temperature between 68°-77°F (20°-25°C).

Is CAREone® gluten-free?

Yes, CAREone® is gluten-free.

What should I keep in mind regarding children and CAREone®?

Keep CAREone® out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Care One Gas Relief (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Care One Gas Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Simethicone is presented in a dosage form of softgels, with each softgel containing 180 mg of simethicone. The product is gluten-free, ensuring suitability for individuals with gluten sensitivities. The formulation is designed for ease of swallowing, and the package contains a total of 60 softgels.

Uses and Indications

This drug is indicated for the relief of bloating, pressure, or fullness commonly referred to as gas. It provides fast relief of gas discomfort, pressure, and bloating.

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

Dosage and Administration

Patients are advised to swallow one or two softgels as needed after a meal. The maximum recommended dosage is two softgels per day, unless otherwise directed by a physician. It is important for healthcare professionals to monitor patients for adherence to this dosage limit to ensure safety and efficacy.

Contraindications

There are no contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if the condition persists.

Warnings and Precautions

It is imperative to keep this medication out of reach of children to prevent accidental ingestion and potential harm.

Patients should discontinue use and consult a healthcare professional if the condition persists despite treatment. This precaution is essential to ensure appropriate management and to rule out any underlying issues that may require further investigation or alternative therapies.

Side Effects

Patients should be advised to stop use and consult a doctor if their condition persists. It is also important to keep this product out of reach of children to prevent any potential adverse reactions or misuse.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Care One Gas Relief (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Care One Gas Relief.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. There are no specific age ranges, dosage differences, or study outcomes provided for pediatric use in the available data. Caution is advised when administering this medication to ensure safety and prevent accidental ingestion by children.

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

There is no specific information regarding the use of CARE ONE GAS RELIEF (simethicone) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this medication in women of childbearing potential and discuss the potential risks and benefits with their patients.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for CARE ONE GAS RELIEF (simethicone). Therefore, healthcare professionals should exercise caution when recommending this product to lactating mothers. The effects on breastfed infants have not been established, and the excretion of simethicone in breast milk is not documented. It is advisable for lactating mothers to consult with their healthcare provider before using this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

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 initiate supportive care, 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 substance involved, the amount ingested, and the time of exposure, 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important for patients to understand that if their condition persists, they should stop using the medication and consult a doctor for further evaluation and guidance.

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 a controlled temperature range of 68° to 77°F (20° to 25°C) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within this temperature range at all times.

Additional Clinical Information

The medication is administered orally, with patients advised to swallow one or two softgels as needed after a meal. It is important for patients not to exceed a total of two softgels per day unless directed by a physician. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Care One Gas Relief, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.