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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 2017
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 2017
Label revision date
November 7, 2023
Manufacturer
AMERISOURCEBERGEN DRUG CORPORATION
Registration number
M001
NDC root
46122-434
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 that this medication is designed to help relieve discomfort associated with heartburn, sour stomach, acid indigestion, and gas. It works by addressing the excess stomach acid that can lead to these uncomfortable symptoms, providing you with relief when you need it most. If you're experiencing any of these issues, this medication could be a helpful option to consider for easing your symptoms.

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 between 10 mL to 20 mL (which is 1 to 2 doses) of the medication. It's best to take it between meals, at bedtime, or as your doctor has instructed.

If you have a child under 12 years old, it's important to consult with a doctor before giving them this medication. Always follow your healthcare provider's advice to ensure safe and effective use.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you do not need to worry about any particular restrictions or warnings regarding its use. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

Taking this medication can lead to some side effects, and it's important to be aware of them. You should not exceed 80 mL (8 doses) in a 24-hour period or use 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, 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 80 mL (8 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 80 mL (which is 8 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. 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 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 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 follow your doctor's advice to ensure safe and effective use.

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 are any concerns about kidney disease or if you are following a magnesium-restricted diet. These conditions can affect how the medication works in your body.

For adults and 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, unless your doctor advises otherwise. If the patient is under 12 years old, please consult a doctor for appropriate guidance. Always prioritize safety and seek professional advice tailored to individual health needs.

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 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 ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 you are taking, 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 in a tightly closed container. It's important to avoid freezing, as this can damage the product and affect its effectiveness.

When handling the product, always make sure to keep it in a clean environment to maintain its quality. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You can take this medication orally, with the recommended dosage for adults and children aged 12 and older being 10 mL to 20 mL (1 to 2 doses) between meals, at bedtime, 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 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 of age 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 for this drug?

Do not take more than 80 mL (8 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 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 tightly closed and do not freeze.

Should I shake the drug before use?

Yes, you should shake well before use.

Can this drug interact with other medications?

Yes, antacids may interact with certain prescription drugs, so consult a doctor or pharmacist if you are currently taking any.

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 the SPL code 34089-3. No additional specific description details are provided in the available text.

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

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, which may be taken as 1 to 2 doses. This should be administered between meals as needed, at bedtime, or as directed by a physician.

For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

Patients should not exceed a maximum dosage of 80 mL (equivalent to 8 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 administration, 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 the safe use of the medication in these populations.

Additionally, it is 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 efficacy or increased risk of side effects.

For pregnant or breastfeeding individuals, consultation with a healthcare professional is imperative before using this medication to assess potential risks to the mother and child.

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

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is crucial not to exceed a dosage of 80 mL (8 doses) within a 24-hour period or to use the maximum dosage for more than 2 weeks, as this may lead to serious health complications.

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, potentially leading to adverse effects.

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

Drug Interactions

Antacids have the potential to interact with various prescription medications, which may affect the absorption and efficacy of these drugs. It is advisable for healthcare professionals to monitor patients closely when antacids are co-administered with other medications.

In cases where antacids are prescribed alongside other drugs, dosage adjustments may be necessary to mitigate any potential interactions. Patients should be counseled on the timing of antacid administration relative to their other medications to optimize therapeutic outcomes and minimize adverse effects.

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 (1 to 2 doses) between meals as needed, at bedtime, or as directed by a healthcare provider.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this medication if they have a history of kidney disease or if they are on a magnesium-restricted diet.

For adults and children aged 12 years and older, the recommended dosage is 10 mL to 20 mL (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 seek guidance from a healthcare provider before administration.

Given the potential for altered pharmacokinetics and increased sensitivity to medications in geriatric patients, careful monitoring and consideration of individual health status are essential when prescribing this medication.

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 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 event of overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. The maximum allowable dosage is 80 mL, which equates to 8 doses, within a 24-hour period. Additionally, the maximum dosage should not be utilized for a duration exceeding 2 weeks.

Healthcare professionals should be vigilant for potential symptoms of overdosage, which may arise from exceeding these limits. In cases where overdosage is suspected, immediate medical evaluation is advised. Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented by the patient.

It is essential for healthcare providers to educate patients on the importance of adhering to prescribed dosages to mitigate the risk of overdosage and its associated complications.

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 provided 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 a tightly closed container and should be stored at room temperature. It is essential to ensure that the product is not exposed to freezing temperatures, as this may compromise its integrity.

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 (1 to 2 doses) taken 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.

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 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.