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Antacid

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Active ingredients
  • Dimethicone 80 mg/10 mL
  • Aluminum Hydroxide 800 mg/10 mL
  • Magnesium Hydroxide 800 mg/10 mL
Other brand names
Drug classes
Calculi Dissolution Agent, Osmotic Laxative
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
December 11, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Dimethicone 80 mg/10 mL
  • Aluminum Hydroxide 800 mg/10 mL
  • Magnesium Hydroxide 800 mg/10 mL
Other brand names
Drug classes
Calculi Dissolution Agent, Osmotic Laxative
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
December 11, 2024
Manufacturer
Retail Business Services, LLC.
Registration number
M001
NDC root
72476-516
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

CAREONE is a maximum strength antacid liquid designed to help relieve various digestive discomforts. It contains active ingredients such as aluminum hydroxide and magnesium hydroxide, which work together to neutralize stomach acid, and simethicone, which helps reduce gas and bloating. This product is effective for alleviating symptoms like acid indigestion, heartburn, sour stomach, and upset stomach associated with gas.

With its original flavor, CAREONE provides a soothing option for those experiencing pressure and bloating due to gas. It is comparable to other well-known antacid products, making it a reliable choice for managing your digestive health.

Uses

If you're experiencing discomfort from acid indigestion, heartburn, or a sour stomach, this medication can help relieve those symptoms. It is also effective for an upset stomach and gas that may accompany these issues.

You can feel confident using this medication, as there are no known teratogenic effects (which means it doesn't cause birth defects) associated with it.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. If you are an adult or a child aged 12 years and older, you should take between 10 to 20 milliliters (mL) of the medication two times a day, unless your doctor advises a different dosage.

If your child is under 12 years old, it’s important to consult a doctor for the appropriate dosage. Always follow your healthcare provider's instructions to ensure safe and effective use of the medication.

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, you should stop using the medication and consult your doctor if your symptoms persist for more than two weeks. This ensures that you receive the appropriate care and support for your health needs. Always prioritize your well-being and seek professional advice when necessary.

Side Effects

It's important to be aware of potential side effects when using this product. You should not exceed 60 mL in a 24-hour period or use the maximum dosage for more than two weeks without consulting your doctor. If your symptoms persist for more than two weeks, stop using the product and seek medical advice.

Before using this product, talk to your doctor if you have kidney disease or are on a magnesium-restricted diet, as these conditions may affect your safety. Additionally, if you are currently taking any prescription medications, consult with your doctor or pharmacist, as antacids can interact with certain drugs.

Warnings and Precautions

It's important to use this product safely. You should not take more than 60 mL in a 24-hour period, and you should not use the maximum dosage for more than two weeks unless your doctor advises you to do so.

If your symptoms persist for more than two weeks, please stop using the product and consult your doctor. While there are no specific emergency instructions provided, it's always best to seek immediate medical help if you experience any severe or concerning symptoms.

Overdose

Taking more than 60 mL of this product in a 24-hour period, or using the maximum dosage for more than 2 weeks without a doctor's guidance, can lead to an overdose. Signs of an overdose may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, it’s important to seek medical help immediately.

If you suspect an overdose, contact your healthcare provider or local emergency services right away. Always remember that it’s better to be cautious and get help if you’re unsure about your symptoms or the amount you’ve taken. Your health and safety are the top priority.

Pregnancy Use

While the information provided does not specify any particular safety concerns or precautions for use during pregnancy, it is always important to consult with your healthcare provider before taking any medication. They can offer personalized advice based on your health and pregnancy status.

Currently, there are no dosage modifications recommended for pregnant individuals, and no specific guidelines are mentioned regarding the use of this medication during pregnancy. Always prioritize open communication with your doctor to ensure the best outcomes for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

If you have a child under 12 years old, it's important to consult a doctor before using this medication. For children aged 12 and older, as well as adults, the recommended dosage is 10 to 20 mL taken twice a day, or as directed by a healthcare professional. Always follow your doctor's advice to ensure safe and effective use for your child.

Geriatric Use

If you are an older adult or caring for one, it's important to be cautious when using this medication. Before starting, you should consult with your doctor if you have kidney disease, as this can affect how the medication works in your body. Additionally, if you are currently taking any prescription medications, it's wise to check with your doctor or pharmacist first, since antacids can interact with some of these drugs.

For adults and children aged 12 and older, the typical dosage is 10 to 20 mL taken twice a day, or as directed by your doctor. If the patient is under 12 years old, please consult a doctor for appropriate guidance. Always prioritize safety and communication with healthcare professionals when managing medications.

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 and what steps to take for your safety.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help you understand how to manage your health while considering your liver condition.

Drug Interactions

It's important to be aware that antacids, which are commonly used to relieve heartburn and indigestion, can interact with some prescription medications. This means that taking antacids at the same time as certain drugs may affect how well those medications work.

To ensure your safety and the effectiveness of your treatment, always discuss any medications you are taking, including over-the-counter products like antacids, with your healthcare provider. They can help you understand potential interactions and adjust your treatment plan if necessary.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20ºC and 25ºC (68ºF to 77ºF). It's important to keep it away from freezing temperatures, as freezing can damage the product.

When handling the product, make sure to maintain a clean environment to avoid contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the effectiveness of the product.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dose is 10 to 20 mL two times a day, or as directed by your doctor. If the patient is under 12 years old, it's important to consult a doctor for the appropriate dosage.

FAQ

What is CAREONE?

CAREONE is a maximum strength antacid liquid that contains aluminum hydroxide, magnesium hydroxide, and simethicone.

What symptoms does CAREONE relieve?

CAREONE relieves acid indigestion, heartburn, sour stomach, and upset stomach and gas associated with these symptoms.

What is the recommended dosage for adults and children 12 years and older?

Adults and children 12 years and older should take 10 - 20 mL two times a day, or as directed by a doctor.

Can children under 12 years use CAREONE?

Children under 12 years should consult a doctor before using CAREONE.

Are there any contraindications for using CAREONE?

No specific contraindications are mentioned for CAREONE.

What should I do if my symptoms last more than two weeks?

You should stop using CAREONE and ask a doctor if your symptoms last more than two weeks.

Is there any alcohol in CAREONE?

Yes, CAREONE contains 0.2% v/v alcohol.

What precautions should I take before using CAREONE?

Ask a doctor before use if you have kidney disease or are on a magnesium-restricted diet, and consult a doctor or pharmacist if you are taking a prescription drug.

How should I store CAREONE?

Store CAREONE at controlled room temperature between 20ºC-25ºC (68º-77ºF) and do not freeze.

Does CAREONE have any teratogenic effects?

No teratogenic effects are mentioned for CAREONE.

Packaging Info

Below are the non-prescription pack sizes of Antacid (aluminum hydroxide, magnesium hydroxide, simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Antacid.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

CAREONE is an antacid liquid formulated for maximum strength relief. Each 12 FL OZ (355 mL) bottle contains the following active ingredients: Aluminum Hydroxide 800 mg, Magnesium Hydroxide 800 mg, and Simethicone 80 mg. The product is presented in an original flavor and has an alcohol content of 0.2% v/v. The National Drug Code (NDC) for this formulation is 72476-516-05. This product is comparable to the active ingredients found in Mylanta® Maximum Strength.

Uses and Indications

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

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

Dosage and Administration

Healthcare professionals are advised to instruct patients to shake the product well before use.

For adults and children aged 12 years and older, the recommended dosage is 10 to 20 mL administered two times a day, or as directed by a physician.

For children under 12 years of age, it is essential to consult a healthcare provider for appropriate dosing recommendations.

All dosages are to be measured in milliliters (mL).

Contraindications

There are no specified contraindications 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

Exceeding a daily dosage of 60 mL is contraindicated, and the maximum dosage of this product should not be utilized for longer than two weeks unless directed and monitored by a healthcare professional. Adherence to this guideline is essential to mitigate potential adverse effects associated with prolonged use.

Healthcare professionals should advise patients to discontinue use and seek medical consultation if symptoms persist beyond a two-week period. This precaution is critical to ensure appropriate evaluation and management of the underlying condition.

While no specific emergency medical instructions are provided, it is imperative for healthcare providers to remain vigilant and prepared to address any unforeseen complications that may arise during treatment.

Currently, there are no laboratory tests specified for monitoring the safe use of this product. However, healthcare professionals should consider individual patient circumstances and may recommend appropriate assessments as deemed necessary.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. It is crucial to adhere to the recommended dosage guidelines, which state that no more than 60 mL should be taken within a 24-hour period, and the maximum dosage should not be used for more than two weeks unless under the advice and supervision of a healthcare professional.

In the event that symptoms persist for more than two weeks, patients are advised to discontinue use and consult a doctor. Additionally, individuals with kidney disease or those on a magnesium-restricted diet should seek medical advice before using this product.

Furthermore, patients currently taking prescription medications should consult with a doctor or pharmacist prior to use, as antacids may interact with certain prescription drugs. These precautions are essential to ensure the safe and effective use of the product.

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 Antacid (aluminum hydroxide, magnesium hydroxide, simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Antacid.
Details

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, the recommended dosage is 10 to 20 mL taken twice daily, or as directed by a healthcare provider.

Geriatric Use

Elderly patients should exercise caution when using this medication, particularly those aged 65 and older. It is advisable for these patients to consult a healthcare provider before use, especially if they have a history of kidney disease.

Additionally, geriatric patients are encouraged to seek guidance from a doctor or pharmacist if they are currently taking any prescription medications, as antacids may interact with certain drugs.

For adults and children aged 12 years and older, the recommended dosage is 10 to 20 mL taken twice daily, or as directed by a healthcare professional. For children under 12 years of age, it is essential to consult a doctor prior to administration.

Close monitoring and appropriate dose adjustments may be necessary to ensure safety and efficacy in the geriatric population.

Pregnancy

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been detailed in the prescribing information. There are no dosage modifications recommended for pregnant individuals, nor are there any special precautions regarding its use during pregnancy. Healthcare professionals should continue to evaluate the benefits and risks when prescribing this medication to women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 cases of overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. The maximum allowable dosage is 60 mL within a 24-hour period. Additionally, the product should not be used at its maximum dosage for more than 2 weeks unless directed by a healthcare professional.

Healthcare providers should be vigilant for symptoms that may arise from overdosage, although specific symptoms are not detailed in the provided information. In the event of suspected overdosage, it is advisable to seek immediate medical attention.

Management of overdosage should involve supportive care and monitoring of the patient’s condition. Healthcare professionals are encouraged to consult relevant medical guidelines and toxicology resources for further management strategies tailored to the specific circumstances of the overdosage incident.

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. 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 patients to seek medical advice before using this medication if they have a history of kidney disease or are on a magnesium-restricted diet. Additionally, patients should be encouraged to discuss their current medications with their healthcare provider or pharmacist, particularly if they are taking any prescription drugs, as antacids may interact with certain medications. This precaution helps ensure safe and effective use of the product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature ranging from 20ºC to 25ºC (68ºF to 77ºF). It is imperative to avoid freezing the product to maintain its integrity and efficacy. Proper handling and storage conditions are essential to ensure the product remains within the specified temperature range.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 10 to 20 mL taken twice daily, or as directed by a healthcare professional. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing guidance.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Antacid, 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 Antacid, 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.

Learn more in our Editorial Policy

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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.