Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Regular Strength Antacid

Last content change checked dailysee data sync status

Active ingredients
  • Dimethicone 20 mg/5 mL
  • Aluminum Hydroxide 200 mg/5 mL
  • Magnesium Hydroxide 200 mg/5 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 2017
Label revision date
November 1, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Dimethicone 20 mg/5 mL
  • Aluminum Hydroxide 200 mg/5 mL
  • Magnesium Hydroxide 200 mg/5 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 2017
Label revision date
November 1, 2023
Manufacturer
VALU MERCHANDISERS COMPANY
Registration number
M001
NDC root
63941-629
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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, a sour stomach, or acid indigestion. This medication is designed to help relieve these symptoms, providing you with comfort and relief. Additionally, it can assist in alleviating the discomfort associated with gas. If you're looking for a solution to these common digestive issues, this medication may 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 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 2 to 4 teaspoonfuls of the medication between meals or at bedtime, unless your doctor has given you different instructions. 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 patient is a child under 12 years old, it's best to consult a doctor before giving them this medication. Always follow your healthcare provider's advice to ensure safe and effective use.

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 mentioned in the provided information. Always follow these guidelines to use the medication safely and effectively.

Side Effects

It's important to be aware of potential side effects and interactions when using this medication. You should consult your doctor if you have kidney disease or are on a magnesium-restricted diet before starting treatment. Additionally, if you are taking any prescription medications, it's wise to check with your doctor or pharmacist, as antacids can interact with certain drugs.

If your symptoms persist for more than two weeks, you should stop using the medication and seek medical advice. If you are pregnant or breastfeeding, please consult a healthcare professional before use to ensure safety for you and your baby.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have kidney disease or are on a magnesium-restricted diet. Additionally, if you are taking any prescription medications, check with your doctor or pharmacist first, as antacids can interact with some drugs.

If your symptoms persist for more than two weeks, stop using the medication and contact your doctor. If you are pregnant or breastfeeding, seek advice from a healthcare professional before use. Always keep this medication out of reach of children to ensure their safety.

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

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 are considering this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. For those aged 12 and older, the recommended dosage is 2 to 4 teaspoonfuls taken between meals or at bedtime, unless your doctor advises otherwise.

Be cautious not to exceed 24 teaspoonfuls in a 24-hour period, and avoid using the maximum dosage for more than two weeks. Always prioritize your child's safety by following these guidelines and seeking medical advice when necessary.

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. 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 your doctor advises otherwise. 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 you are caring for 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 your kidney health and follow your doctor's guidance closely.

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 want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be aware that antacids can interact with some prescription medications. This means that taking them together might affect how well your prescription drugs work. To ensure your safety and the effectiveness of your treatment, always talk to your doctor or pharmacist before using antacids if you are currently on any prescription medication. They can provide guidance tailored to your specific health needs.

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 the device. Always keep the container tightly closed when not in use to maintain its integrity and safety. Following these simple guidelines will help you use the product effectively and safely.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls between meals or at bedtime, unless your doctor advises otherwise. It's important not to exceed 24 teaspoonfuls in a 24-hour period or to use the maximum dosage for more than 2 weeks. If the patient is under 12 years old, consult a doctor for appropriate guidance.

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 24 hours?

You should 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?

You should ask a doctor before use if you have kidney disease.

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

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

What should I do if my symptoms last more than 2 weeks?

You should stop use and ask a doctor if symptoms last more than 2 weeks.

Are there any precautions I should take when using this drug?

Keep this drug out of reach of children and ask a doctor or pharmacist before use if you are taking a prescription drug, as antacids may interact with certain medications.

How should I store this drug?

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

What should children under 12 do before using this drug?

Children under 12 years should ask a doctor before use.

What should I do before taking this drug if I am on a magnesium-restricted diet?

You should ask a doctor before use if you are on a magnesium-restricted diet.

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 identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. It is debossed with the letter "A" on one side and the number "1" on the opposite side. Each tablet contains 1 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and color additives.

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

There are no specific contraindications listed for this product. However, it is advised to keep the product out of reach of children to prevent accidental ingestion or misuse.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have a history of kidney disease or are on a magnesium-restricted diet. It is also advisable to seek guidance from a doctor or pharmacist if the patient is currently taking any prescription medications, as antacids may interact with certain drugs.

In the event that symptoms persist for more than two weeks, the patient should discontinue use and consult a healthcare provider for further evaluation. Additionally, pregnant or breastfeeding individuals are encouraged to seek advice from a health professional before using this product.

To ensure safety, this product should be kept out of reach of children to prevent accidental ingestion.

Side Effects

Patients should be aware of several important warnings associated with the use of this medication. It is advised that individuals consult a doctor prior to use if they have kidney disease or are on a magnesium-restricted diet. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking any prescription medications, as antacids may interact with certain drugs.

In the event that symptoms persist for more than two weeks, patients are instructed to discontinue use and consult a doctor. Furthermore, pregnant or breastfeeding individuals should consult a health professional before using this product to ensure safety for both the mother and child.

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 ensure safe and effective use of both antacids and the prescribed medications.

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 2 to 4 teaspoonfuls taken between meals, at bedtime, or as directed by a healthcare provider.

It is important to note 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.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have kidney disease, as this may affect 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage data, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 use of the compound in these contexts.

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 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. Additionally, the container must remain tightly closed to maintain the integrity of the product.

Additional Clinical Information

The medication is administered orally. 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. Patients should not exceed 24 teaspoonfuls within a 24-hour period and should not use the maximum dosage for more than 2 weeks. For children under 12 years of age, it is advised to consult a doctor before 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.