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Regular Strength Antacid

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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 2014
Label revision date
November 6, 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 2014
Label revision date
November 6, 2023
Manufacturer
Chain Drug Marketing Association
Registration number
M001
NDC root
63868-712
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 looking for a medication that helps relieve discomfort from heartburn, sour stomach, acid indigestion, and gas. This type of medication works by addressing the symptoms associated with excess stomach acid, providing you with relief from these common digestive issues. If you're experiencing any of these symptoms, 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 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 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 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 instructions 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 associated with this medication. Always follow the guidance provided to use it safely and effectively.

Side Effects

It's important to be aware of potential side effects when using this medication. You should consult your doctor if you have kidney disease or are on a magnesium-restricted diet, as these conditions may affect your use of the drug. Additionally, if you are taking any prescription medications, it's wise to check with your doctor or pharmacist, since 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 using this product to ensure it is safe 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. If you experience any severe reactions or unusual symptoms, seek emergency help immediately.

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 concerned about a possible overdose, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any doubts.

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, at bedtime, or as directed 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 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 there is a history of kidney disease. Additionally, if you or the person you are caring for is taking any prescription medications, check with a doctor or pharmacist to avoid potential interactions.

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 professional. Be cautious not to exceed 24 teaspoonfuls in a 24-hour period, and avoid using the maximum dosage for more than two weeks. For children under 12, always consult a doctor before use.

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 for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

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 medications 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 drugs. They can provide guidance tailored to your specific situation.

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 affect its effectiveness. 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 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 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?

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

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

Stop use and ask a doctor if symptoms last more than 2 weeks.

What precautions should I take when using this drug?

Keep 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.

What should I do if I want to give this drug to a child under 12 years?

Ask a doctor before use for children under 12 years.

How should I store this drug?

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

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

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. Each tablet is debossed with "A" on one side and "1" on the other side, containing 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 consecutive weeks.

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

Contraindications

Use of this product is contraindicated in children due to the risk of accidental ingestion. It is essential to keep the product out of reach of children to prevent potential harm. No other contraindications have been identified.

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, it is imperative to keep this medication out of reach of children.

Side Effects

Patients should be aware of several important warnings associated with the use of this medication. It is advised to consult a doctor before use if there is a history of kidney disease or if the patient is on a magnesium-restricted diet. Additionally, patients taking prescription medications should seek guidance from a healthcare professional, 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 also seek advice from a health professional prior to using this medication.

Drug Interactions

Antacids have the potential to interact with various prescription medications, which may affect the efficacy and safety of those drugs. 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 medications. This precaution helps ensure appropriate management of potential interactions and may necessitate dosage adjustments or increased monitoring based on the specific medications involved.

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 aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls taken between meals, at bedtime, or as directed by a physician.

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 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, to avoid potential drug interactions.

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 limit of 24 teaspoonfuls within a 24-hour period and to avoid using the maximum dosage for more than 2 weeks to mitigate the risk of adverse effects.

For children under 12 years of age, it is essential to consult a healthcare provider before administration. This precaution ensures that the treatment is appropriate and safe for younger patients.

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 currently no available data regarding the excretion of this medication 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management for suspected cases of drug overdose.

It is essential to monitor the patient closely for any signs or symptoms that may arise, as the clinical presentation can vary widely depending on the substance involved. Common symptoms of overdose may include, but are not limited to, altered mental status, respiratory depression, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include airway management, monitoring of vital signs, and intravenous fluid administration as necessary. The use of specific antidotes should be considered based on the substance involved, if applicable.

Furthermore, it is recommended that healthcare professionals consult local poison control centers or toxicology experts for guidance on the management of overdose cases, including the potential need for activated charcoal or other decontamination measures.

Documentation of the incident, including the substance involved, estimated dose, time of ingestion, and any interventions performed, is crucial for ongoing patient management and for informing future care decisions.

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 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 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.