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Antacid

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This product has been discontinued

Active ingredients
  • Dimethicone 20 mg/5 mL
  • Aluminum Hydroxide 200 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 20 mg/5 mL
  • Aluminum Hydroxide 200 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
53807-126
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to help relieve discomfort caused by heartburn, acid indigestion, and sour stomach. If you've ever felt the unpleasant effects of overindulging in food and drink, this drug can also assist in alleviating those symptoms, including gas and upset stomach. It works by addressing the underlying causes of these digestive issues, providing you with relief when you need it most.

Uses

If you're experiencing discomfort from heartburn, acid indigestion, or a sour stomach, this medication can help relieve those symptoms. It’s also effective for easing the discomfort associated with gas and an upset stomach, making it a good choice if you've overindulged in food and drink.

You can rely on this medication to provide relief from these common digestive issues, helping you feel more comfortable after meals or during times of digestive distress.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well to mix the contents properly. If you are an adult or a child aged 12 years and older, you can take 2 to 4 teaspoonsful of the medication between meals or at bedtime, or as your doctor advises. However, be careful not to exceed 12 teaspoonsful in a 24-hour period, and avoid using the maximum dosage for more than two weeks.

If the patient is a child under 12 years old, it’s important to consult a physician (doctor) before giving them this medication to ensure it’s safe and appropriate for their age. Always follow your healthcare provider's instructions for the best results.

What to Avoid

You should avoid using this medication if you have kidney disease or if you are on a magnesium-restricted diet. It's important to stop using it if your symptoms persist for more than two weeks. In the event of an accidental overdose, seek medical assistance or contact a Poison Control Center right away. Always prioritize your health and safety by following these guidelines.

Side Effects

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, as antacids can interact with some of these drugs.

If your symptoms persist for more than two weeks, stop using the medication and seek medical advice. Always keep this product out of reach of children, and in the event of an accidental overdose, contact medical help or a Poison Control Center right away.

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 certain drugs.

If your symptoms persist for more than two weeks, stop using the medication and reach out to your doctor for further guidance. In the event of an accidental overdose, seek emergency medical help or contact a Poison Control Center right away. Always keep this medication out of reach of children to ensure their safety.

Overdose

If you suspect an accidental overdose, it’s crucial to seek medical help right away or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always keep emergency contact numbers handy and be aware of the signs to ensure your safety and well-being.

Pregnancy Use

While the provided information does not specify any particular safety concerns or dosage modifications for pregnant individuals, it is always important to consult with your healthcare provider before taking any medication during pregnancy. They can provide personalized advice based on your health and circumstances.

Since there are no special precautions mentioned regarding use during pregnancy, maintaining open communication with your doctor about any medications you are considering is essential. This ensures that you receive the safest and most effective care for both you and your baby.

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 to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If you are considering this medication for your child, it's important to know that it is not recommended for children under 12 years old without consulting a physician (a medical doctor). For those aged 12 and older, the typical dosage is between 2 to 4 teaspoonsful taken between meals or at bedtime, as directed by a healthcare provider.

Be mindful not to exceed 12 teaspoonsful in a 24-hour period, and avoid using the maximum dosage for more than two weeks. Always follow your doctor's guidance to ensure safe and effective use.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

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 open communication with your doctor regarding your kidney health to ensure the best care.

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 need to conduct regular tests to ensure your safety while using any medication.

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 antacids can interact with these medications, which may affect how well they work or increase the risk of side effects.

Always keep your healthcare provider informed about all the medications you are taking, including over-the-counter products, to ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally between 15º - 30ºC (59º - 86ºF). Make sure to keep the container tightly closed to prevent contamination and protect it from freezing, as extreme temperatures can affect its performance.

Before using the product, check the breakaway band on the cap. If it is broken or missing, do not use the product, as this indicates it may have been tampered with. Following these guidelines will help you handle the product safely and maintain its integrity.

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, or as directed by your doctor. It's important not to exceed 12 teaspoonsful in a 24-hour period and to avoid using the maximum dosage for more than two weeks. If you have a child under 12 years, please consult a physician before use.

FAQ

What symptoms does this drug relieve?

This drug relieves heartburn, acid indigestion, sour stomach, and associated symptoms of gas and upset stomach, as well as overindulgence of food and drink.

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, but not more than 12 teaspoonsful in 24 hours.

Are there any contraindications for using this drug?

Do not use this drug if you have kidney disease or are on a magnesium-restricted diet.

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

You should stop using the drug and ask a doctor if your symptoms last for more than 2 weeks.

What should I do in case of an accidental overdose?

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

Is this drug safe to use during pregnancy or while nursing?

There are no specific warnings or recommendations regarding the use of this drug during pregnancy or nursing mothers.

How should I store this drug?

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

What should I do if I am taking a prescription drug?

Ask a doctor or pharmacist before use, as antacids may interact with certain prescription drugs.

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

The product contains 500 mg of calcium carbonate as the active ingredient. Inactive components include dextrose, magnesium stearate, microcrystalline cellulose, and sodium bicarbonate. The formulation is presented as a white, round tablet. It is packaged in a child-resistant container to ensure safety.

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, as well as discomfort resulting from overindulgence in food and drink.

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

Dosage and Administration

The medication should be shaken well before each use to ensure proper mixing of the formulation. 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 not to exceed a total of 12 teaspoonsful within a 24-hour period. Additionally, the maximum dosage should not be used for more than 2 weeks consecutively.

For children under 12 years of age, it is advised to consult a physician prior to administration to determine the appropriate dosage and ensure safety.

Contraindications

Use is contraindicated in patients with kidney disease due to the potential for exacerbating renal impairment. Additionally, the product should not be used in individuals on a magnesium-restricted diet, as it may lead to adverse effects related to magnesium levels.

Patients should also refrain from using this product if symptoms persist for more than 2 weeks. In the event of an accidental overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

Warnings and Precautions

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

Patients should be advised to consult a physician prior to use if they have a history of kidney disease or are on a magnesium-restricted diet. These conditions may affect the safety and efficacy of the treatment.

It is also essential to recommend that patients speak with their doctor or pharmacist before using this medication if they are currently taking any prescription drugs. Antacids have the potential to interact with certain prescription medications, which could lead to adverse effects or reduced therapeutic efficacy.

Patients should be instructed to discontinue use and seek medical advice if symptoms persist for more than two weeks. Prolonged symptoms may indicate an underlying condition that requires further evaluation.

In the event of an accidental overdose, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay. This is critical to ensure the safety and well-being of the patient.

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

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 taking prescription medications should seek guidance from a healthcare professional or pharmacist, 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. It is crucial to keep this medication out of reach of children. In cases of accidental overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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 these interactions are a concern.

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 or at bedtime, or as directed by a physician. The maximum dosage should not exceed 12 teaspoonsful within a 24-hour period, and this maximum dosage should not be used for more than 2 weeks.

For children under 12 years of age, consultation with a physician is advised prior to use.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The available data regarding the use of this medication during pregnancy is limited. There are no specific safety concerns outlined for pregnant patients, nor are there any dosage modifications recommended for this population. Additionally, no special precautions have been identified for the use of this medication in pregnant individuals. Healthcare professionals should consider the potential benefits and risks when prescribing this medication to women of childbearing potential. As always, it is advisable to monitor for any adverse effects and to counsel patients accordingly.

Lactation

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

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the event of an accidental overdose, it is imperative to seek medical assistance promptly. Healthcare professionals are advised to contact a Poison Control Center immediately for guidance on managing the situation effectively.

Symptoms of overdose may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential. Monitoring vital signs and observing for any unusual symptoms will aid in determining the appropriate course of action.

Management of an overdose should be tailored to the individual case, taking into account the substance involved and the severity of symptoms. Supportive care may be necessary, and specific interventions should be implemented as recommended by medical professionals or poison control experts.

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 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 also be encouraged to consult with their healthcare provider before using this 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. The maximum dosage should not exceed 12 teaspoonsful within a 24-hour period, and this maximum dosage should not be used for more than 2 weeks. For children under 12 years, consultation with a physician is recommended prior to use.

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.