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Antacid and Gasrelief

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Active ingredients
  • Dimethicone 80 mg/10 mL
  • Aluminum Hydroxide 800 mg/10 mL
  • Magnesium Hydroxide 800 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 2020
Label revision date
November 7, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Dimethicone 80 mg/10 mL
  • Aluminum Hydroxide 800 mg/10 mL
  • Magnesium Hydroxide 800 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 2020
Label revision date
November 7, 2023
Manufacturer
GOODSENSE
Registration number
M001
NDC root
50804-638
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

You may be experiencing discomfort from heartburn, sour stomach, acid indigestion, or gas. This medication is designed to help relieve these symptoms, providing you with comfort and support when you need it most. By targeting the underlying causes of these digestive issues, it aims to restore balance and ease your discomfort.

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 should take between 10 mL and 20 mL (which is 1 to 2 doses) two times a day, unless your doctor advises otherwise. It's important not to exceed 40 mL (or 4 doses) in a 24-hour period, and you should not use the maximum dosage for more than 2 weeks.

If your child is under 12 years old, please consult a doctor before giving them this medication. Following these guidelines will help ensure that you use the medication safely and effectively.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use the medication responsibly.

Side Effects

Before using this medication, it's important to consult with 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 certain drugs.

If your symptoms persist for more than two weeks, you should stop using the medication and seek medical advice. If you are pregnant or breastfeeding, please consult a healthcare professional before use.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have kidney disease or are on a magnesium-restricted diet. Additionally, if you are taking any prescription medications, check with your doctor or pharmacist first, as antacids can interact with some drugs.

If your symptoms persist for more than two weeks, stop using the medication and contact your doctor. If you are pregnant or breastfeeding, seek advice from a healthcare professional before using this product. Always keep this medication out of reach of children to ensure their safety.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are concerned about a possible overdose, seek medical help right away.

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

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you are considering this medication for your child, it's important to know that children under 12 years of age should consult a doctor before use. For those aged 12 and older, the recommended dosage is between 10 mL to 20 mL (1 to 2 doses) taken twice a day, unless your doctor advises otherwise.

Be cautious not to exceed 40 mL (4 doses) in a 24-hour period, and avoid using the maximum dosage for more than two weeks. Always follow your healthcare provider's guidance to ensure safe and effective use.

Geriatric Use

If you are an older adult or caring for one, it's important to be cautious when using this medication. Before starting, consult with your doctor if you have kidney disease, as this can affect how the medication works in your body. Additionally, if you are taking any prescription drugs, check with your doctor or pharmacist, since some antacids can interact with these medications.

For adults and children aged 12 and older, the recommended dosage is 10 mL to 20 mL (1 to 2 doses) taken twice a day, unless your doctor advises otherwise. Be careful not to exceed 40 mL (4 doses) in a 24-hour period, and avoid using the maximum dosage for more than two weeks. If the person you are caring for is under 12 years old, please consult a doctor for guidance.

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 want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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 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 best performance of your product, store it at room temperature in a tightly closed container. Avoid freezing, as this can damage the product and affect its effectiveness.

When handling the product, make sure to keep it in a clean environment to maintain its quality and safety. Always follow these storage and handling guidelines to ensure optimal use.

Additional Information

You should take this medication orally, with adults and children aged 12 and older typically taking 10 mL to 20 mL (1 to 2 doses) twice a day, unless your doctor advises otherwise. It's important not to exceed 40 mL (4 doses) in a 24-hour period or to use the maximum dosage for more than 2 weeks. If you are under 12 years old, consult a doctor for the appropriate dosage.

Before using this medication, ask your doctor if you have kidney disease or are on a magnesium-restricted diet. It's also wise to check with your doctor or pharmacist if you are taking any prescription medications. If your symptoms persist for more than 2 weeks, stop using the medication and consult a doctor. Pregnant or breastfeeding individuals should seek advice from a health professional before use. Always keep this medication out of reach of children.

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) two times a day, or as directed by a doctor.

What is the maximum dosage I should not exceed?

Do not exceed 40 mL (4 doses) in a 24-hour period or use the maximum dosage for more than 2 weeks.

What should I do if I have kidney disease?

Ask a doctor before use if you have kidney disease or a magnesium-restricted diet.

Can I take this drug if I am pregnant or breastfeeding?

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

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

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

What 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.

What precautions should I take regarding children?

Keep this drug out of reach of children and consult a doctor before use for children under 12 years of age.

How should I store this drug?

Store at room temperature tightly closed and do not freeze.

What should I do before using this drug?

Shake well before use and consult a doctor if you have any health concerns.

Packaging Info

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

Packaging configurations for Antacid and Gasrelief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by the SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes several inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc, hydroxypropyl methylcellulose, titanium dioxide, and iron oxides (red and yellow).

Uses and Indications

This drug is indicated for the relief of heartburn, sour stomach, acid indigestion, and symptoms associated with gas.

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

Dosage and Administration

The medication should be shaken well before use. For adults and children aged 12 years and older, the recommended dosage is 10 mL to 20 mL, administered two times a day, or as directed by a healthcare professional. It is important not to exceed a total of 40 mL (4 doses) 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, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in individuals who are unable to keep it out of reach of children. This precaution is essential to prevent accidental ingestion or misuse by pediatric patients. No other contraindications have been identified.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have a history of kidney disease or are on a magnesium-restricted diet. It is also advisable to seek guidance from a doctor or pharmacist if the patient is currently taking any prescription medications, as antacids may interact with certain drugs.

In the event that symptoms persist for more than two weeks, the patient should discontinue use and consult a healthcare provider for further evaluation. Additionally, pregnant or breastfeeding individuals should seek advice from a health professional before using this product.

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

Side Effects

Patients should be aware of several important warnings associated with the use of this medication. It is advised 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, as antacids may interact with certain drugs.

In the event that symptoms persist for more than two weeks, patients are instructed to discontinue use and consult a doctor. Furthermore, pregnant or breastfeeding individuals should also seek advice from a health professional before using this product.

Drug Interactions

Antacids may interact with various 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. Specifically, antacids should be taken at least 2 hours apart from other drugs to ensure optimal therapeutic outcomes. Healthcare professionals should consider this timing when prescribing medications that may be affected by antacids.

Packaging & NDC

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

Packaging configurations for Antacid and Gasrelief.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 10 mL to 20 mL (1 to 2 doses) taken twice daily, or as directed by a healthcare provider.

It is important to note that the maximum dosage should not exceed 40 mL (4 doses) within a 24-hour period, and the maximum dosage should not be used for more than 2 weeks.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use, particularly if they have a history of kidney disease. It is also advisable for geriatric patients to seek guidance from a doctor or pharmacist if they are currently taking any prescription medications, as antacids may interact with certain drugs.

For adults and children aged 12 years and older, the recommended dosage is 10 mL to 20 mL (1 to 2 doses) taken twice daily, or as directed by a healthcare professional. It is crucial for elderly patients to adhere to the maximum dosage limit of 40 mL (4 doses) within a 24-hour period and to avoid using the maximum dosage for more than 2 weeks without medical supervision.

For children under 12 years of age, it is essential to consult a doctor before administration. Careful monitoring and adherence to these guidelines are recommended to ensure the safety and efficacy of treatment in geriatric patients.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers. It is essential to store the product at room temperature, ensuring that the container remains tightly closed to maintain its integrity. Freezing the product is strictly prohibited, as it may compromise its quality and effectiveness. Proper handling and storage conditions are crucial for preserving the product's stability and efficacy.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 10 mL to 20 mL (1 to 2 doses) taken twice daily, unless otherwise directed by a healthcare provider. Patients should not exceed 40 mL (4 doses) within a 24-hour period or use the maximum dosage for more than two weeks. For children under 12 years of age, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to seek medical advice before use if they have kidney disease or are on a magnesium-restricted diet. Additionally, patients taking prescription medications should consult a doctor or pharmacist before use. They should discontinue use and consult a healthcare provider if symptoms persist beyond two weeks. Pregnant or breastfeeding individuals are also advised to consult a health professional before use. It is important to keep the medication out of reach of children.

Drug Information (PDF)

This file contains official product information for Antacid and Gasrelief, 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 and Gasrelief, 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.