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Antacid

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Active ingredients
  • Dimethicone 40 mg/5 mL
  • Aluminum Hydroxide 400 mg/5 mL
  • Magnesium Hydroxide 400 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 2015
Label revision date
January 21, 2016
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Dimethicone 40 mg/5 mL
  • Aluminum Hydroxide 400 mg/5 mL
  • Magnesium Hydroxide 400 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 2015
Label revision date
January 21, 2016
Manufacturer
Safeway
Registration number
part332
NDC root
21130-508
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

This medication is a maximum strength antacid liquid designed to help relieve various stomach discomforts. It contains aluminum hydroxide and magnesium hydroxide, both of which are antacids that work by neutralizing stomach acid. Additionally, it includes simethicone, which helps reduce gas and bloating.

You can use this antacid liquid to alleviate symptoms such as acid indigestion, heartburn, sour stomach, and upset stomach associated with gas. It provides quick relief, making it a helpful option for managing these common digestive issues.

Uses

You can use this medication to help relieve discomfort from several common digestive issues. It is effective for alleviating acid indigestion, heartburn, and sour stomach. If you're experiencing an upset stomach or gas related to these symptoms, this medication can also provide relief.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safe option for managing your digestive discomfort.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls taken two times a day, unless your doctor advises otherwise.

If the patient is a child under 12 years old, it’s important to consult a doctor for the appropriate dosage. Always follow your healthcare provider's instructions to ensure safe and effective use of the medication.

What to Avoid

It's important to be mindful of your health when using this medication. If your symptoms persist for more than two weeks, you should stop using it and consult your doctor for further guidance. This ensures that you receive the appropriate care and support for your condition.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always prioritize your well-being and seek professional advice if you have any questions or concerns.

Side Effects

It's important to be aware of potential side effects when using this product. You should not exceed 8 teaspoonfuls in a 24-hour period or use the maximum dosage for more than 2 weeks without consulting your doctor. If you have kidney disease or are on a magnesium-restricted diet, please talk to 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 certain drugs.

If your symptoms persist for more than two weeks, stop using the product and consult your doctor. Always keep this medication out of reach of children to ensure their safety.

Warnings and Precautions

It's important to use this product safely. Do not take more than 8 teaspoonfuls in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks unless your doctor advises you to do so. 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 your symptoms persist for more than two weeks, stop using the product and contact your doctor. 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

Taking more than 8 teaspoonfuls of this product in a 24-hour period, or using the maximum dosage for more than 2 weeks without a doctor's guidance, can lead to an overdose. Signs of an overdose may include unusual symptoms that could affect your health. If you suspect an overdose, it’s important to seek immediate medical help.

If you experience any concerning symptoms or if you have taken too much of the product, contact your healthcare provider or local emergency services right away. Always remember to follow the recommended dosage guidelines to ensure your safety.

Pregnancy Use

If you are pregnant or planning to become pregnant, you may be wondering about the safety of using this antacid. The information available does not specify any risks or contraindications for using this product during pregnancy, meaning there are no known dangers to your baby. Additionally, there are no recommended changes to the dosage for pregnant individuals, and no special precautions are noted.

While the absence of warnings is reassuring, it's always a good idea to consult with your healthcare provider before starting any new medication during pregnancy to ensure it’s the right choice for you.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

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 twice a day, or as directed by a healthcare professional. Be mindful not to exceed 8 teaspoonfuls in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks unless advised by a doctor.

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 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 2 to 4 teaspoonfuls taken twice a day, or as directed by your healthcare provider. If the person is under 12 years old, please consult a doctor for appropriate guidance. Always prioritize safety and seek professional advice when it comes to medication 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. Additionally, if you are currently taking any prescription medications, including antacids, be sure to discuss this with your doctor or pharmacist, as these can interact with your other medications. Taking these precautions can help ensure your safety and the effectiveness of your treatment.

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 talk to your doctor or pharmacist before using this medication, especially if you are currently taking any prescription drugs. Some medications, like antacids, can interact with your prescription medications, potentially affecting how well they work or increasing the risk of side effects.

Always keep your healthcare provider informed about all the medications you are taking to ensure your treatment is safe and effective. This way, you can avoid any unexpected interactions and get the best possible care.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20°C and 25°C (68°F and 77°F). It's important to keep it away from freezing temperatures, as freezing can damage the product.

When handling the product, make sure to maintain a clean environment to avoid contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the effectiveness of the product.

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 taken twice a day, 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 is this medication used for?

This medication is used to relieve acid indigestion, heartburn, sour stomach, and upset stomach and gas associated with these symptoms.

What are the active ingredients in this antacid?

The active ingredients include Aluminum Hydroxide (400 mg), Magnesium Hydroxide (400 mg), and Simethicone (40 mg).

How should I take this medication?

Adults and children 12 years and older should take 2 to 4 teaspoonfuls two times a day, or as directed by a doctor. Children under 12 years should consult a doctor.

Are there any warnings I should be aware of?

Do not take more than 8 teaspoonfuls in a 24-hour period or use the maximum dosage for more than 2 weeks without a doctor's advice. Stop use and ask a doctor if symptoms last more than two weeks.

Should I consult a doctor before using this medication?

Yes, you should ask a doctor before use if you have kidney disease, are on a magnesium-restricted diet, or are taking a prescription drug, as antacids may interact with certain medications.

Is this medication safe to use during pregnancy?

The insert does not mention any specific risks or contraindications for use during pregnancy, but you should consult a doctor for personalized advice.

How should I store this medication?

Store at controlled room temperature between 20°C-25°C (68°F-77°F) and do not freeze.

What should I do if I miss a dose?

If you miss a dose, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and continue with your regular schedule.

What should I do if I take too much?

If you take more than the recommended dosage, seek medical attention immediately.

How should I prepare the medication before use?

Shake well before use to ensure proper mixing of the ingredients.

Packaging Info

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

Packaging configurations for Antacid.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This formulation is a maximum strength antacid liquid, designed to provide effective relief from heartburn and indigestion. It contains Aluminum Hydroxide (400 mg) and Magnesium Hydroxide (400 mg), both of which serve as active antacid ingredients. Additionally, the formulation includes Simethicone (40 mg), an active ingredient that aids in the reduction of gas. The product is presented in a cherry flavor, enhancing palatability while maintaining its therapeutic efficacy.

Uses and Indications

This drug is indicated for the relief of symptoms associated with acid indigestion, heartburn, sour stomach, and upset stomach, including gas related to these conditions.

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

Dosage and Administration

Healthcare professionals should instruct patients to shake the product well before use.

For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls taken two times a day, or as directed by a physician.

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

Contraindications

There are no specified contraindications for the use of this product. However, it is advised to discontinue use and consult a healthcare professional if symptoms persist for more than two weeks.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

Dosage Limitations It is imperative that patients do not exceed a maximum dosage of 8 teaspoonfuls within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than 2 weeks unless directed and supervised by a healthcare provider.

Pre-existing Conditions Patients with kidney disease or those on a magnesium-restricted diet should consult a physician prior to using this product. These conditions may affect the safety and efficacy of the treatment.

Drug Interactions Healthcare professionals should advise patients to seek guidance from a doctor or pharmacist if they are currently taking any prescription medications. Antacids have the potential to interact with certain prescription drugs, which may necessitate adjustments in therapy or monitoring.

Duration of Use If symptoms persist beyond two weeks, patients are advised to discontinue use and consult a healthcare provider for further evaluation and management.

Pediatric Safety This product should be kept 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 product. It is crucial to adhere to the recommended dosage guidelines, which state that no more than 8 teaspoonfuls should be taken within a 24-hour period, and the maximum dosage should not be used for more than 2 weeks unless under the advice and supervision of a healthcare professional.

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

If symptoms persist for more than two weeks, patients are advised to discontinue use and consult a doctor. It is also important to keep this product out of reach of children to prevent accidental ingestion.

Drug Interactions

Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking any prescription drugs.

Antacids may have the potential to interact with specific prescription medications, which could alter the effectiveness of those drugs. It is essential for patients to disclose all medications they are taking to ensure safe and effective use of antacids. Monitoring for any adverse effects or changes in therapeutic outcomes is recommended when antacids are used concurrently with prescription medications.

Packaging & NDC

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

Packaging configurations for Antacid.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor before use. For adolescents and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls taken twice daily, or as directed by a healthcare professional. The maximum dosage should not exceed 8 teaspoonfuls within a 24-hour period, and the product should not be used at maximum dosage for more than 2 weeks unless advised and supervised by a doctor. It is important to keep this product out of reach of children.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have a history of kidney disease, as this may affect the safety and efficacy of the treatment. Additionally, those on a magnesium-restricted diet are advised to seek medical advice before initiating therapy.

For dosing, adults and children aged 12 years and older are recommended to take 2 to 4 teaspoonfuls two times a day, or as directed by a healthcare professional. It is important to note that for children under 12 years of age, consultation with a doctor is necessary to determine appropriate dosing and safety considerations.

Healthcare providers should closely monitor geriatric patients for any adverse effects or complications, particularly in those with pre-existing health conditions.

Pregnancy

There are no specific statements regarding the use of this product during pregnancy. The available data does not indicate any contraindications or risks to the fetus associated with the use of this antacid in pregnant patients. Additionally, no dosage modifications for pregnant individuals are provided. The insert does not include any special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of specific data when advising women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available regarding excretion in breast milk or effects on nursing infants.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have kidney disease. It is also advisable for patients to seek guidance from a doctor or pharmacist if they are currently taking any prescription medications, as antacids may interact with certain drugs. Monitoring and appropriate dosing adjustments may be necessary based on individual renal function.

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 8 teaspoonfuls within a 24-hour period. Additionally, the product should not be used at its maximum dosage for more than 2 weeks unless directed by a healthcare professional.

Healthcare providers should be vigilant for potential symptoms of overdosage, which may arise from exceeding these dosage limits. Symptoms can vary based on individual patient factors and the specific product involved.

In the event of suspected overdosage, it is imperative to seek immediate medical attention. Management procedures may include supportive care and symptomatic treatment, tailored to the patient's clinical presentation. Continuous monitoring and assessment are essential to ensure patient safety and effective management of any adverse effects that may occur.

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 text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion.

Patients should be informed to discontinue use and consult a doctor if their symptoms persist for more than two weeks, as this may indicate a need for further evaluation.

It is important for patients to seek medical advice before using this medication if they have a history of kidney disease, as this condition may affect the safety and efficacy of the treatment.

Additionally, patients on a magnesium-restricted diet should be encouraged to discuss their dietary restrictions with their healthcare provider prior to use, as the medication may contain magnesium.

Lastly, healthcare providers should recommend that patients consult with their doctor or pharmacist before using this medication if they are currently taking any prescription drugs, as antacids may interact with certain medications, potentially altering their effectiveness.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20°C to 25°C (68°F to 77°F). Freezing is not permitted, as it may compromise the integrity of the product. Proper handling and storage conditions are essential to maintain the product's efficacy and safety.

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 twice daily, or as directed by a healthcare professional. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing guidance.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for 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 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

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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.