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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
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 2000
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
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 2000
Label revision date
November 7, 2023
Manufacturer
AMERISOURCEBERGEN DRUG CORPORATION
Registration number
M001
NDC root
46122-433
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 be experiencing discomfort from heartburn, sour stomach, acid indigestion, or gas. This medication is designed to help relieve these symptoms, providing you with comfort and relief. It works by addressing the excess stomach acid that can lead to these uncomfortable feelings, allowing you to feel more at ease. If you're looking for a solution to these common digestive issues, this medication could be a helpful 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. 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. If you are an adult or a child aged 12 years and older, you can take 2 to 4 teaspoonfuls between meals or at bedtime, unless your doctor advises otherwise. However, it’s important not to exceed 24 teaspoonfuls in a 24-hour period, and you should not use the maximum dosage for more than 2 weeks.

If the person taking the medication is under 12 years old, it’s best to consult a doctor for guidance on the appropriate dosage. Always follow these instructions carefully to ensure safe and effective use of the medication.

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 concerns regarding abuse, misuse, or dependence associated with this medication. Always follow safety guidelines to use it responsibly.

Side Effects

It's important to be aware of potential side effects and warnings 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 use. Additionally, if you are taking any prescription medications, check with your doctor or pharmacist, as antacids can interact with certain drugs. If you are pregnant or breastfeeding, it's advisable to seek guidance from a healthcare professional.

Always keep this medication out of reach of children to ensure their safety.

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 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 can lead to an overdose. It's important to avoid using the maximum dosage for longer than 2 weeks, as this can increase the risk of serious side effects.

If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing (respiratory depression). If you notice any of these symptoms, seek immediate medical help. Always prioritize your safety and consult a healthcare professional if you have any concerns about your medication use.

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 your child is under 12 years old, it's important to consult a doctor before giving them this medication. For those aged 12 and older, the recommended dosage is 2 to 4 teaspoonfuls taken between meals or at bedtime, unless directed otherwise by a healthcare professional.

Be cautious not to exceed 24 teaspoonfuls in a 24-hour period, and avoid using the maximum dosage for more than two weeks. Always keep this medication out of reach of children to ensure their safety.

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 there is a history of kidney disease. Additionally, if you are taking any prescription medications, check with your doctor or pharmacist first, as antacids can interact with certain drugs.

For adults and children aged 12 and older, the recommended dosage is 2 to 4 teaspoonfuls taken between meals or at bedtime, unless directed otherwise by a healthcare provider. Be cautious not to exceed 24 teaspoonfuls in a 24-hour period, and avoid using the maximum dosage for more than two weeks. If the person is under 12 years old, please consult a doctor for guidance.

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 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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to be aware that antacids can interact with some prescription medications. This means that if you are taking any prescription drugs, you should consult with your doctor or pharmacist before using antacids. They can help ensure that your medications work effectively and safely together. Always prioritize open communication about all the medications and supplements you are taking to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to protect it from freezing, as extreme cold can damage it. Always keep the container tightly closed when not in use to maintain its integrity and safety. Following these simple storage guidelines will help you use the product effectively and safely.

Additional Information

You should take this medication orally. Before using it, consult your doctor if you have kidney disease, are pregnant or breastfeeding, or if you are taking any prescription medications, as antacids can interact with certain drugs. It's always best to check with a healthcare professional to ensure safe use.

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 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor.

What is the maximum dosage I can take in a day?

Do not take more than 24 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks.

What should I do if I have kidney disease?

Ask a doctor before use if you have kidney disease.

Can I use this drug if I am pregnant or breastfeeding?

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

What should I do if I am taking a prescription drug?

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

What precautions should I take regarding children?

Keep this drug out of reach of children and consult a doctor for children under 12 years.

How should I store this drug?

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

Is there any information on teratogenic effects?

No teratogenic effects are mentioned for this drug.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

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 product is a liquid antacid formulated to provide relief from heartburn and indigestion. It contains Aluminum Hydroxide and Magnesium Hydroxide as active ingredients. Inactive ingredients include water, sorbitol, flavoring agents, preservatives, and coloring agents. The SPL code for this product is 34089-3.

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 to ensure proper mixing of the formulation.

For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls taken between meals, at bedtime, or as directed by a healthcare professional. It is important not to exceed a maximum of 24 teaspoonfuls within a 24-hour period, and the maximum dosage should not be used for more than 2 weeks.

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

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 use 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 on a magnesium-restricted diet are advised to consult a healthcare professional. This precaution is critical to ensure safety and efficacy in these populations.

Additionally, it is recommended that patients seek advice 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 side effects.

For pregnant or breastfeeding individuals, consultation with a healthcare professional is necessary before use to assess potential risks to the mother and child.

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

Side Effects

Patients should be aware of the following warnings and adverse reactions associated with the use of this medication. It is crucial not to exceed a dosage of 120 mL (12 doses) within a 24-hour period or to use the maximum dosage for more than 2 weeks. Prior to use, patients with kidney disease or those on a magnesium-restricted diet should consult a healthcare professional. Additionally, individuals 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 use.

It is also important to keep this medication out of reach of children to prevent accidental ingestion.

Drug Interactions

Antacids may interact with certain prescription medications, potentially affecting their efficacy. It is advisable for patients to consult with a healthcare professional, such as a doctor or pharmacist, prior to using antacids if they are currently taking any prescription drugs. This precaution helps to ensure safe and effective use of both antacids and prescribed therapies, minimizing the risk of adverse interactions.

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 adults aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls taken between meals, at bedtime, or as directed by a healthcare provider. It is important not to exceed 24 teaspoonfuls within a 24-hour period and to avoid using the maximum dosage for more than 2 weeks. Additionally, this product should be kept out of reach of children to ensure safety.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use, particularly if they have a history of kidney disease, as this may influence the safety and efficacy of the treatment. Additionally, it is advisable for geriatric patients 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 2 to 4 teaspoonfuls taken between meals, at bedtime, or as directed by a healthcare professional. It is crucial for elderly patients to adhere to the maximum dosage guidelines, which stipulate that no more than 24 teaspoonfuls should be taken within a 24-hour period, and the maximum dosage should not be used for more than 2 weeks.

For children under 12 years of age, it is essential to consult a doctor before administration. This precaution is particularly important in the geriatric population, where careful monitoring and adherence to dosing recommendations are vital to ensure safety and minimize the risk of adverse effects.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 the event 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 weeks consecutively.

Healthcare professionals should be vigilant for potential symptoms of overdosage, which may vary depending on the specific medication involved. In cases where overdosage is suspected, immediate medical evaluation is advised.

Management of overdosage should include supportive care and symptomatic treatment as necessary. It is essential to monitor the patient closely and provide appropriate interventions based on the clinical presentation. If necessary, consult a poison control center or a medical toxicologist for further guidance on the management of overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 to emphasize the necessity of proper storage and handling to ensure the safety of young individuals.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from freezing conditions. Additionally, it is essential to keep the container tightly closed to maintain the integrity of the product.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients to consult a doctor before use if they have kidney disease. Additionally, patients are encouraged to speak with a doctor or pharmacist if they are taking any prescription medications, as antacids may interact with certain drugs. Pregnant or breastfeeding patients should also seek guidance from a health professional prior to use.

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.