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Antacid

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Active ingredients
  • Dimethicone 40 mg/10 mL
  • Aluminum Hydroxide 400 mg/10 mL
  • Magnesium Hydroxide 400 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 40 mg/10 mL
  • Aluminum Hydroxide 400 mg/10 mL
  • Magnesium Hydroxide 400 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
72476-509
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 regular strength antacid liquid designed to help relieve various digestive discomforts. It contains key ingredients such as aluminum hydroxide and magnesium hydroxide, which work together to neutralize stomach acid, and simethicone, which helps reduce gas and bloating.

You can use CAREONE to alleviate symptoms like acid indigestion, heartburn, sour stomach, and upset stomach associated with gas. This product aims to provide you with quick relief from the pressure and discomfort that can come from these common digestive issues.

Uses

If you're experiencing discomfort from acid indigestion, heartburn, or a sour stomach, this medication can help relieve those symptoms. It’s also effective for upset stomach and gas that may accompany these issues, as well as the pressure and bloating caused by gas.

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. This makes it a safer option for those who may be concerned about such risks.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. For adults and children aged 12 years and older, the recommended dose is between 10 milliliters (mL) and 20 mL, taken four times a day, unless your doctor advises a different amount.

If you have a child 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. You should not take it if your symptoms persist for more than two weeks, as this may indicate a need for further medical evaluation.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always consult with your healthcare provider if you have any concerns or questions about your treatment.

Side Effects

It's important to be aware of potential side effects when using this product. You should not exceed 80 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 how you should use it. 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. Do not exceed 80 mL in a 24-hour period, and avoid using 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, stop using the product and consult your doctor.

Before using this product, please check with your doctor if you have kidney disease or are on a magnesium-restricted diet. Additionally, if you are currently taking any prescription medications, it's wise to speak with your doctor or pharmacist, as antacids can interact with certain drugs. Always prioritize your health and safety by following these guidelines.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific signs or symptoms listed for an overdose, you should be aware of general warning signs such as extreme drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or feel something is wrong, 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

If you are pregnant or planning to become pregnant, it’s important to consult your doctor before using this product. While there are no specific warnings or contraindications noted for its use during pregnancy, your healthcare provider can give you personalized advice based on your individual health needs. Always prioritize open communication with your doctor to ensure the safety of both 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 passed into breast milk or if it poses any risk to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

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, the recommended dosage is between 10 mL to 20 mL, taken four times a day, or as directed by a healthcare professional. Always follow your doctor's advice to ensure the safety and effectiveness of the treatment 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 certain drugs.

For adults and children aged 12 and older, the recommended dosage is 10 mL to 20 mL taken four times a day, or as directed by your healthcare provider. 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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to be adjusted based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary changes to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that your medication is safe and effective for you.

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 your other medications could affect how well those medications work.

To ensure your treatment is safe and effective, always discuss any medications, 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 mL to 20 mL four 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 regular strength antacid liquid that helps relieve symptoms like acid indigestion, heartburn, and upset stomach.

What are the key ingredients in CAREONE?

The key ingredients in CAREONE are aluminum hydroxide (400 mg), magnesium hydroxide (400 mg), and simethicone (40 mg).

How should I take CAREONE?

Adults and children 12 years and older should take 10 mL to 20 mL four times a day, or as directed by a doctor. Children under 12 years should consult a doctor.

Are there any warnings associated with CAREONE?

Do not take more than 80 mL in a 24-hour period or use the maximum dosage for more than 2 weeks without a doctor's advice.

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

If your symptoms last more than two weeks, you should stop using CAREONE and consult a doctor.

Can I use CAREONE if I have kidney disease?

You should ask a doctor before using CAREONE if you have kidney disease or are on a magnesium-restricted diet.

Is CAREONE safe to use during pregnancy?

There are no specific warnings regarding the use of CAREONE during pregnancy, but you should consult a doctor if you are pregnant or plan to become pregnant.

Can nursing mothers use CAREONE?

There are no specific warnings or recommendations regarding the use of CAREONE in nursing mothers.

What should I do if I am taking other prescription drugs?

You should ask a doctor or pharmacist before using CAREONE if you are currently taking a prescription drug, as antacids may interact with certain medications.

How should I store CAREONE?

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

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 Regular Strength Antacid Liquid is formulated to provide relief from heartburn and indigestion. Each 12 FL OZ (355 mL) bottle contains aluminum hydroxide (400 mg), magnesium hydroxide (400 mg), and simethicone (40 mg) as active ingredients. 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 72476-509-05.

Uses and Indications

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

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 mL to 20 mL administered four 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.

Contraindications

Use is contraindicated in patients whose symptoms persist for more than two weeks. Prolonged symptoms may indicate an underlying condition that requires further evaluation and management.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Dosage Limitations Patients should not exceed a maximum dosage of 80 mL within a 24-hour period. Furthermore, the maximum dosage should not be utilized for more than two weeks unless directed and supervised by a healthcare professional.

Duration of Use If symptoms persist beyond two weeks, it is essential to discontinue use and consult a physician for further evaluation and guidance.

Pre-existing Conditions Prior to use, individuals should seek medical advice if they have a history of kidney disease or are on a magnesium-restricted diet. These conditions may necessitate special consideration and monitoring.

Drug Interactions Patients currently taking prescription medications should consult with a healthcare provider or pharmacist before using this product. Antacids have the potential to interact with certain prescription drugs, which may affect their efficacy or safety.

By following these guidelines, healthcare professionals can help ensure the safe and effective use of this product in their patients.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur if the maximum dosage of 80 mL is exceeded within a 24-hour period or if the product is used for more than 2 weeks without the advice and supervision of a healthcare professional.

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

It is also important for 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.

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 effects and to avoid diminished efficacy of the prescribed treatments.

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 aged 12 years and older, the recommended dosage is 10 mL to 20 mL taken four times a day, or as directed by a physician.

Geriatric Use

Elderly patients should exercise caution when using this medication, particularly those aged 65 and older. It is advisable for geriatric patients to consult a healthcare provider before use if they have a history of kidney disease, as this may influence the safety and efficacy of the treatment.

Additionally, elderly patients are encouraged to seek guidance from a doctor or pharmacist prior to using this medication if they are currently taking any prescription drugs. This is important because antacids may interact with certain prescription medications, potentially leading to adverse effects or reduced therapeutic efficacy.

For dosing, the recommended administration for adults and children aged 12 years and older is 10 mL to 20 mL four times a day, or as directed by a healthcare professional. For children under 12 years of age, it is essential to consult a doctor for appropriate dosing recommendations.

Monitoring and dose adjustments may be necessary for geriatric patients to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients or those planning to become pregnant should consult a healthcare professional before using this product. Currently, there are no specific warnings or contraindications associated with the use of this product during pregnancy. However, it is advisable for women of childbearing potential to seek medical advice regarding the use of this product to ensure safety for both the mother and the developing fetus.

Lactation

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

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 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

For further guidance, healthcare professionals are encouraged to consult local poison control centers or relevant clinical guidelines to determine the most appropriate management strategies tailored to the specific circumstances of the overdose.

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 instructed to stop 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 the 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 upon request. It should be stored at a controlled room temperature of 20ºC to 25ºC (68ºF to 77ºF). Freezing is not permitted, as it may compromise the integrity of the product. Proper handling and storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 10 mL to 20 mL taken four times a day, 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.

No additional information is 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.