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Antacid

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This product has been discontinued

Active ingredients
  • Dimethicone 25 mg/5 mL
  • Aluminum Hydroxide 225 mg/5 mL
  • Magnesium Hydroxide 200 mg/5 mL
Other brand names
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 1999
Label revision date
April 30, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Dimethicone 25 mg/5 mL
  • Aluminum Hydroxide 225 mg/5 mL
  • Magnesium Hydroxide 200 mg/5 mL
Other brand names
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 1999
Label revision date
April 30, 2018
Manufacturer
Rij Pharmaceutical Corporation
Registration number
part332
NDC root
53807-151
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 this medication helpful if you experience discomfort from heartburn, acid indigestion, or a sour stomach. It works to relieve these symptoms, including the pressure and bloating often associated with gas and upset stomach. This can provide you with much-needed comfort and ease during those uncomfortable moments.

Uses

You can use this medication to help relieve various digestive discomforts. It effectively alleviates heartburn, acid indigestion, and sour stomach, making it easier for you to enjoy your meals without the nagging pain of these conditions.

Additionally, if you're experiencing symptoms like gas, upset stomach, pressure, or bloating, this medication can provide relief from those uncomfortable feelings as well. It's designed to help you feel more comfortable and at ease after eating.

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 teaspoonsful of the medication between meals, at bedtime, or as your doctor advises. However, be careful not to exceed 12 teaspoonsful in a 24-hour period, and do not use the maximum dosage for more than 2 weeks.

If the patient is a child under 12 years old, it’s important to consult a physician (doctor) before giving them this medication. This ensures that the child receives the appropriate care and dosage tailored to their needs.

What to Avoid

It's important to be aware of certain precautions when using this medication. While there are no specific contraindications listed, you should never hesitate to seek medical help if you suspect an accidental overdose. In such cases, contacting a Poison Control Center immediately is crucial for your safety.

Always remember that while this medication is safe for many, it’s essential to use it responsibly. If you have any concerns about how to use it or its effects, don’t hesitate to reach out to your healthcare provider for guidance. Your health and safety are the top priority.

Side Effects

It's important to be aware of potential side effects and warnings when using this medication. You should not exceed 12 teaspoonfuls in a 24-hour period or use the maximum dosage for more than two weeks unless directed by your doctor. 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, it's wise to speak with your doctor or pharmacist, as antacids can interact with certain drugs.

Warnings and Precautions

It's important to use this medication safely. Do not exceed 12 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 taking any prescription medications, check with your doctor or pharmacist, as antacids can interact with certain drugs.

If you accidentally take too much, seek emergency medical help or contact a Poison Control Center right away. Also, if your symptoms persist for more than 2 weeks, stop using the medication and reach out to your doctor for further guidance.

Overdose

Taking more than 12 teaspoonfuls of this medication 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 drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, it’s important to seek medical help immediately.

If you suspect an overdose, contact your healthcare provider or local emergency services right away. Always follow the recommended dosage guidelines to ensure your safety and well-being.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult your doctor before using this product. While there are no specific warnings or contraindications noted for its use during pregnancy, your healthcare provider can help you make the best decision for your health and your baby's safety. Always prioritize open communication with your physician regarding any medications or products you consider using during this time.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

When it comes to using this medication for children, it's important to know the guidelines. For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonsful taken between meals or at bedtime, unless your doctor advises otherwise.

However, if your child is under 12 years old, you should consult a physician (a medical doctor) before giving them this medication. This ensures that your child receives the appropriate care and dosage tailored to their specific needs. Always prioritize your child's health by seeking professional advice.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to remember that each person is unique. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate for your individual health needs.

Since there are no specific dosage adjustments or safety concerns mentioned for elderly patients, you should still be vigilant about any changes in health or side effects. Regular check-ins with your doctor can help manage any potential issues that may arise.

Renal Impairment

If you have kidney 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 include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation and any other health factors you may have.

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 could affect how well those medications work.

To ensure your safety and the effectiveness of your treatment, 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 safety and effectiveness of your product, store it at room temperature, ideally between 15º - 30ºC (59º - 86ºF). It's important to keep the container tightly closed to maintain its integrity and protect it from freezing, which can damage the contents.

Before use, check the breakaway band on the cap; do not use the product if this band is broken or missing, as this indicates that the product may have been tampered with. Following these guidelines will help you use the product safely and effectively.

Additional Information

For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonsful taken between meals or at bedtime, unless your doctor advises otherwise. It's important to follow your physician's instructions regarding the timing and amount of the medication you take.

Currently, there is no additional information available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What symptoms does this drug relieve?

This drug relieves heartburn, acid indigestion, sour stomach, and associated symptoms of gas and upset stomach, including pressure and bloating.

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 teaspoonsful between meals, at bedtime, or as directed by a physician.

What is the maximum dosage I should take?

Do not take more than 12 teaspoonsful in a 24-hour period or use the maximum dosage for more than 2 weeks, unless advised by a physician.

What should I do if I accidentally take too much?

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

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

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

Is this drug safe to use during pregnancy?

Consult a physician if you are pregnant or plan to become pregnant, as there are no specific warnings or contraindications listed regarding its use during pregnancy.

Can nursing mothers use this drug?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

How should I store this drug?

Store at room temperature between 15º - 30ºC (59º - 86ºF), keep tightly closed, and protect from freezing.

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

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

What should I check for before using this product?

Ensure the breakaway band on the cap is not broken or missing, as this indicates tampering.

Packaging Info

Below are the non-prescription pack sizes of Antacid (aluminum hydroxide, magnesium hydroxide, 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

Each tablet contains 500 mg of Calcium Carbonate. Inactive ingredients include Dextrose, Magnesium Stearate, Microcrystalline Cellulose, Natural and Artificial Flavors, and Talc. The tablets are characterized as white, round, and biconvex in shape.

Uses and Indications

This drug is indicated for the relief of heartburn, acid indigestion, and sour stomach. It also alleviates associated symptoms of gas and upset stomach, including pressure and bloating commonly referred to as gas.

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 each use. For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonsful taken between meals, at bedtime, or as directed by a physician. It is important to note that patients should not exceed 12 teaspoonsful 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, a consultation with a physician is advised prior to administration to determine the appropriate dosage and ensure safety.

Contraindications

There are no specified contraindications for the use of this product. However, in the event of an accidental overdose, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

Patients should not exceed a maximum dosage of 12 teaspoonfuls within a 24-hour period or utilize the maximum dosage for longer than 2 weeks without the guidance and supervision of a physician.

Healthcare professionals are advised to exercise caution and recommend that patients consult a physician prior to use if they have a history of kidney disease or are on a magnesium-restricted diet. Additionally, it is prudent to advise patients to seek guidance from a doctor or pharmacist before using this product if they are currently taking any prescription medications, as antacids may interact with certain drugs.

In the event of an accidental overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Patients should discontinue use and consult their healthcare provider if symptoms persist for more than 2 weeks.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is crucial to adhere to the recommended dosage guidelines, which stipulate that no more than 12 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 physician.

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

Monitoring for adverse reactions is essential, and patients should report any unexpected symptoms or concerns to their healthcare provider.

Drug Interactions

Antacids may interact with certain prescription medications, potentially affecting their absorption and efficacy. It is advisable to monitor the timing of antacid administration in relation to other medications to minimize these interactions. Healthcare professionals should consider advising patients to space the administration of antacids and other medications to ensure optimal therapeutic outcomes.

Packaging & NDC

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

Packaging configurations for Antacid.
Details

Pediatric Use

Pediatric patients aged 12 years and older may take 2 to 4 teaspoonsful between meals, at bedtime, or as directed by a physician. For children under 12 years, it is recommended to consult a physician prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age-related considerations. There are no recommended dosage adjustments or safety concerns specifically outlined for geriatric patients. Additionally, no special precautions are indicated for this population.

Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering the absence of specific data on geriatric use. Monitoring for efficacy and safety in this demographic is advised, given the general variability in response to medications among older adults.

Pregnancy

Pregnant patients or those planning to become pregnant should consult a physician before using this product. While there are no specific warnings or contraindications listed regarding the use of this product during pregnancy, it is essential for healthcare providers to evaluate the potential risks and benefits on a case-by-case basis. As with any medication, careful consideration and professional guidance are recommended to ensure the safety of both the mother and the developing fetus.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 12 teaspoonfuls within a 24-hour period. Exceeding this limit or utilizing the maximum dosage for more than two weeks should only occur under the guidance and supervision of a qualified physician.

Healthcare professionals should be vigilant for potential symptoms of overdosage, which may arise from excessive intake. In the event of suspected overdosage, 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 following dosage recommendations to mitigate the risk of overdosage and its associated complications.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an accidental overdose. It is important for patients to be informed that they should discontinue use and consult a doctor if their symptoms persist for more than two weeks.

Patients should be encouraged to consult with their healthcare provider before using the medication if they have a history of kidney disease or if they are on a magnesium-restricted diet. Additionally, healthcare providers should recommend that patients speak with their doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs.

Storage and Handling

The product is supplied in a tamper-evident container. It should not be used if the breakaway band on the cap is broken or missing.

Storage conditions require the product to be maintained at room temperature, specifically between 15ºC and 30ºC (59ºF to 86ºF). It is essential to keep the container tightly closed to ensure product integrity. Additionally, the product must be protected from freezing to maintain its efficacy.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 to 4 teaspoonsful of the medication between meals or at bedtime, or as directed by a physician. 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 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

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.