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Antacid and Gasrelief

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Active ingredients
  • Dimethicone 40 mg/10 mL
  • Aluminum Hydroxide 400 mg/10 mL
  • Magnesium Hydroxide 400 mg/10 mL
Other brand names
Drug classes
Calculi Dissolution Agent, Osmotic Laxative
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2020
Label revision date
June 10, 2024
Active ingredients
  • Dimethicone 40 mg/10 mL
  • Aluminum Hydroxide 400 mg/10 mL
  • Magnesium Hydroxide 400 mg/10 mL
Other brand names
Drug classes
Calculi Dissolution Agent, Osmotic Laxative
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2020
Label revision date
June 10, 2024
Manufacturer
GOODSENSE
Registration number
M001
NDC root
50804-629

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

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

Drug Overview

You may find that this medication is designed to help relieve discomfort associated with heartburn, sour stomach, acid indigestion, and gas. It works by addressing the excess stomach acid that can lead to these uncomfortable symptoms, providing you with relief when you need it most. If you're experiencing any of these issues, this medication could be a helpful option to consider.

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. Enjoy relief from your digestive discomfort and get back to feeling your best.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. If you are an adult or a child aged 12 years and older, you can take between 10 mL to 20 mL (which is 1 to 2 doses) of the medication. It’s best to take it between meals, at bedtime, or as your doctor advises.

Be careful not to exceed 120 mL (or 12 doses) in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks. If you have a child under 12 years of age, please consult a doctor before giving them this medication.

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 to use it safely and effectively.

Side Effects

It's important to be aware of potential side effects when using this medication. You should consult your doctor if you have kidney disease or are on a magnesium-restricted diet, as these conditions may affect how you can safely use the product. Additionally, if you are taking any prescription medications, it's wise to check with your doctor or pharmacist, since 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 using this product to ensure it is safe for you and your baby.

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 use.

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

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 unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

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 it is not recommended for children under 12 years of age without consulting a doctor first. Always reach out to your child's healthcare provider to discuss any concerns or questions you may have regarding their treatment. This ensures that your child receives the safest and most effective care tailored to their needs.

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 medications, check with your doctor or pharmacist first, since antacids can interact with certain drugs.

For adults and children aged 12 and older, the recommended dosage is between 10 mL to 20 mL (1 to 2 doses) taken between meals or at bedtime, as needed or directed by a doctor. However, do not exceed 120 mL (12 doses) in a 24-hour period, and avoid using the maximum dosage for more than two weeks. If the person is under 12 years old, please consult a doctor before 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 and if any adjustments to your dosage are necessary. Always prioritize your kidney health and follow your doctor's guidance closely.

Hepatic Impairment

If you have liver problems, it's important to know that 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 tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

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. It's important to protect it from freezing, as extreme temperatures can affect its effectiveness. Always make sure the container remains tightly closed to maintain its quality and safety.

When handling the product, be mindful of keeping it in a clean environment to avoid contamination. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You can take this medication orally, with the recommended dosage for adults and children aged 12 and older being 10 mL to 20 mL (1 to 2 doses) between meals, at bedtime, or as directed by your doctor. It's important not to exceed 120 mL (12 doses) in a 24-hour period, and you should not use the maximum dosage for more than 2 weeks. If you have a child under 12 years old, consult a doctor for appropriate dosing guidance.

FAQ

What symptoms does this drug relieve?

This drug relieves heartburn, sour stomach, acid indigestion, and symptoms referred to as gas.

What is the recommended dosage for adults and children 12 years and older?

Adults and children 12 years of age and older should take 10 mL to 20 mL (1 to 2 doses) between meals as needed, at bedtime, or as directed by a doctor.

What is the maximum dosage I can take in a day?

Do not exceed 120 mL (12 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.

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

If 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 precautions should I take regarding children?

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

How should I store this drug?

Store at room temperature tightly closed and protect from freezing.

Should I shake the drug before use?

Yes, you should shake well before use.

Can this drug interact with other medications?

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

Packaging Info

Below are the non-prescription pack sizes of Antacid and Gasrelief (aluminum hydroxide, magnesium hydroxide, dimethicone). 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 product is identified by the SPL Code 34089-3. No additional specific description details are provided in the available text.

Uses and Indications

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

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

Dosage and Administration

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, which may be taken as 1 to 2 doses between meals as needed, at bedtime, or as directed by a healthcare professional.

It is important not to exceed a total of 120 mL (12 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 is contraindicated in individuals who are unable to keep the product out of reach of children. This precaution is necessary 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 are encouraged to seek advice from a health professional before using this product.

To ensure safety, this product should be kept 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 to consult a doctor prior to use if there is a history of kidney disease or if the patient is 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. These precautions are essential to ensure the safe and effective use of the medication.

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. 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 and Gasrelief (aluminum hydroxide, magnesium hydroxide, dimethicone). 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. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use, particularly if they have a history of kidney disease, as this may influence the safety and efficacy of the treatment. Additionally, it is advisable for geriatric patients to seek guidance from a doctor or pharmacist if they are currently taking any prescription medications, due to the potential for interactions with antacids.

For adults and children aged 12 years and older, the recommended dosage is 10 mL to 20 mL (1 to 2 doses) between meals as needed, at bedtime, or as directed by a healthcare professional. It is crucial for elderly patients to adhere to the maximum dosage limit of 120 mL (12 doses) within a 24-hour period and to avoid using the maximum dosage for more than 2 weeks to mitigate the risk of adverse effects.

For children under 12 years of age, it is essential to consult a healthcare provider before administration. This precaution is particularly important in the geriatric population, where careful monitoring and dose adjustments may be necessary to ensure safety and effectiveness.

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 the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 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 compound in these areas.

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 for patients to understand the potential risks associated with improper access to the medication by young children. Providers should encourage patients to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It should be stored at room temperature, ensuring that the container remains tightly closed to prevent contamination and degradation. Additionally, it is crucial to protect the product from freezing, as exposure to low temperatures may compromise its efficacy. Proper handling and storage conditions are essential to maintain the quality and safety of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 10 mL to 20 mL (1 to 2 doses) between meals as needed, at bedtime, or as directed by a healthcare professional. Patients should not exceed 120 mL (12 doses) within a 24-hour period and should not use the maximum dosage for more than 2 weeks. For children under 12 years of age, it is advised to consult a doctor before use.

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.

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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.