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Regular Strength 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
Suspension
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
November 7, 2023
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
Suspension
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
November 7, 2023
Manufacturer
KROGER COMPANY
Registration number
M001
NDC root
30142-637
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

You may find this medication helpful if you experience discomfort from heartburn, sour stomach, acid indigestion, or gas. It is designed to relieve these symptoms, providing you with a sense of comfort and relief from digestive issues.

This medication works by addressing the underlying causes of these symptoms, helping to neutralize stomach acid and reduce discomfort. If you're looking for a solution to ease your digestive troubles, this could be a suitable option for you.

Uses

If you're experiencing discomfort from heartburn, a sour stomach, or acid indigestion, this medication can help relieve those symptoms. It also addresses issues related to gas, providing you with some much-needed comfort.

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. Enjoy relief from your digestive discomfort and get back to feeling your best.

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 can take between 10 mL to 20 mL (which is about 1 to 2 doses) as needed. It's best to take it between meals or at bedtime, unless your doctor has given you different instructions.

For children under 12 years old, it's important to consult a doctor before giving them this medication. When measuring your dose, use the dosing cup that comes with the medication to ensure accuracy. Remember, 1 mL is equal to one milliliter, which is a standard measurement for liquid medications.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use the medication responsibly.

Side Effects

It's important to be aware of potential side effects when using this medication. You should not exceed 120 mL (12 doses) in a 24-hour period or use the maximum dosage for more than two weeks. If you have kidney disease or are on a magnesium-restricted diet, consult your doctor before using this product. Additionally, if you are currently taking any prescription medications, it's wise to check with your doctor or pharmacist, as antacids can interact with certain drugs. If you are pregnant or breastfeeding, please seek advice from a healthcare professional before use.

Warnings and Precautions

It's important to use this medication safely. Do not take more than 120 mL (12 doses) in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks. If you have kidney disease or are on a magnesium-restricted diet, consult your doctor before using this product. Additionally, if you are currently taking any prescription medications, check with your doctor or pharmacist, as antacids can interact with some drugs.

If you are pregnant or breastfeeding, please speak with a healthcare professional before using this medication. Always keep it out of reach of children to ensure their safety. If you experience any severe reactions or have concerns, seek emergency help immediately or stop use and contact your doctor.

Overdose

Taking more than 120 mL (which is 12 doses) of this medication in a 24-hour period, or using the maximum dosage for longer than 2 weeks, can lead to an overdose. Signs of an overdose may include unusual symptoms that could affect your health, so it's important to be aware of how much you are taking.

If you suspect an overdose, seek immediate medical help. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your dosage or experience any unusual symptoms. Remember, following the recommended dosage is crucial for your safety and well-being.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, the recommended dosage is between 10 mL to 20 mL, which can be taken as needed between meals or at bedtime, or as directed by a healthcare professional. Always ensure you follow the guidance provided by your doctor to keep your child safe and healthy.

Geriatric Use

If you are an older adult or caring for one, it's important to consult with a doctor before using this medication, especially if you have kidney disease. Kidney disease can affect how your body processes medications, so your doctor can help determine if this treatment is safe for you.

Additionally, if you are currently taking any prescription medications, be sure to talk to your doctor or pharmacist before starting this drug. Some over-the-counter products, like antacids, can interact with prescription medications, which may lead to unwanted side effects. Always prioritize open communication with your healthcare providers to ensure safe and effective treatment.

Renal Impairment

If you have kidney disease, it's important to consult your doctor before using this medication. Your healthcare provider can help determine if it's safe for you and if any adjustments to your dosage are necessary. Always prioritize open communication with your doctor regarding your kidney health to ensure the best care.

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 determine the best approach based on your liver function and overall health.

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 treatments, 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 room temperature and protect it from freezing. It's important to keep the container tightly closed when not in use to maintain its integrity and effectiveness. Following these simple guidelines will help you handle the product safely and effectively.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What symptoms does this drug relieve?

This drug relieves heartburn, sour stomach, acid indigestion, and symptoms referred to as gas.

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

Adults and children 12 years and older should take 10 mL to 20 mL (1 to 2 doses) between meals as needed, at bedtime, or as directed by a doctor.

What should children under 12 do before using this drug?

Children under 12 years should ask a doctor before use.

Are there any warnings associated with this drug?

Do not take more than 120 mL (12 doses) in a 24-hour period or use the maximum dosage for more than 2 weeks. Consult a doctor if you have kidney disease or are on a magnesium-restricted diet.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

How should this drug be stored?

Store at room temperature, protect from freezing, and keep tightly closed.

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

Ask a doctor or pharmacist before use, as antacids may interact with certain prescription drugs.

Is there any specific information regarding liver problems?

No specific information regarding hepatic impairment or dosage adjustments for patients with liver problems is provided.

What is the method of administration for this drug?

The drug is administered orally.

What should I do if I have kidney disease?

Ask a doctor before use if you have kidney disease.

Packaging Info

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

Packaging configurations for Regular Strength Antacid.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "123" on the other. Each tablet contains 500 mg of Acetaminophen. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, stearic acid, povidone, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, iron oxide red, and iron oxide yellow.

Uses and Indications

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

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

Dosage and Administration

The medication should be shaken well before use. For adults and children aged 12 years and older, the recommended dosage is 10 mL to 20 mL, which may be taken as 1 to 2 doses between meals as needed, at bedtime, or as directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a doctor for appropriate dosing. The medication should be measured using the dosing cup provided to ensure accurate administration.

Contraindications

Use is contraindicated in individuals who are unable to keep the product out of reach of children. This precaution is necessary to prevent accidental ingestion or misuse by pediatric patients. No other contraindications have been identified.

Warnings and Precautions

Patients should not exceed a maximum dosage of 120 mL (12 doses) within a 24-hour period, nor should they utilize the maximum dosage for longer than 2 weeks. Adherence to these guidelines is essential to prevent potential adverse effects associated with overuse.

Prior to use, individuals with kidney disease or those adhering to a magnesium-restricted diet are advised to consult a healthcare professional. This precaution is critical to ensure safety and efficacy in these populations.

It is also recommended that patients seek guidance from a doctor or pharmacist if they are currently taking any prescription medications. Antacids may interact with certain prescription drugs, which could lead to diminished therapeutic effects or increased risk of side effects.

For pregnant or breastfeeding individuals, consultation with a healthcare professional is necessary before initiating use. This step is vital to assess any potential risks to the mother or child.

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

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this medication. It is advised not to exceed a dosage of 120 mL (12 doses) within a 24-hour period, nor should the maximum dosage be used for more than two weeks.

Individuals with kidney disease or those on a magnesium-restricted diet should consult a healthcare professional prior to use. Additionally, patients currently taking prescription medications should seek advice from a doctor or pharmacist, as antacids may interact with certain drugs.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional before using this product to ensure safety for both the patient and the child.

Drug Interactions

Antacids have the potential to interact with various prescription medications, which may affect 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 Regular Strength Antacid (aluminum hydroxide, magnesium hydroxide, dimethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Regular Strength 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 mL to 20 mL, which may be taken as 1 to 2 doses between meals, at bedtime, or as directed by a healthcare provider.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this medication, particularly if they have a history of kidney disease. The renal function may be compromised in geriatric patients, which could necessitate careful monitoring and potential dosage adjustments.

Additionally, it is advisable for elderly patients to seek guidance from a doctor or pharmacist if they are currently taking any prescription medications. There is a possibility of interactions between antacids and certain prescription drugs, which may affect the safety and efficacy of treatment. Therefore, thorough medication reconciliation and assessment of potential drug interactions are essential 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this drug 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, particularly if they have a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of 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 cases of overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. The maximum allowable dosage is 120 mL (equivalent to 12 doses) within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than 2 consecutive weeks.

Healthcare professionals should be vigilant for potential symptoms of overdosage, which may arise from exceeding these dosage limits. In the event of suspected overdosage, immediate medical evaluation is advised.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient’s condition is essential to address any complications that may arise. It is recommended that healthcare providers consult relevant clinical guidelines and toxicology resources for specific management protocols tailored to the substance involved in the overdosage.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, no data has been provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young individuals. Providers should emphasize the necessity of storing the medication in a secure location, away from children's sight and reach, to ensure safety.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It must be stored at room temperature, away from extreme temperatures, and protected from freezing. To maintain the integrity of the product, it is essential to keep the container tightly closed when not in use.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Regular Strength 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 Regular Strength 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

Last AI update:

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.