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Melox

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Active ingredients
  • Dimethicone, Unspecified 20 mg/5 mL
  • Aluminum Hydroxide 200 mg/5 mL
  • Magnesium Hydroxide 200 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 2018
Label revision date
November 20, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Dimethicone, Unspecified 20 mg/5 mL
  • Aluminum Hydroxide 200 mg/5 mL
  • Magnesium Hydroxide 200 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 2018
Label revision date
November 20, 2025
Manufacturer
Belmora LLC
Registration number
M001
NDC root
27854-115
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

Melox is a medication designed to help relieve discomfort caused by acid indigestion, heartburn, sour stomach, and gas. If you experience these symptoms, Melox may provide you with the relief you need to feel more comfortable. It works by addressing the underlying causes of these digestive issues, helping to restore balance and ease your discomfort.

Uses

If you're experiencing discomfort from acid indigestion, heartburn, or a sour stomach, this medication can help relieve those symptoms. It’s also effective for alleviating gas-related issues, making it a useful option for managing digestive discomfort.

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 choice for those concerned about potential 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 can take 2 to 4 teaspoonfuls of the medication between meals, at bedtime, or as your doctor advises. However, it’s important not to exceed 16 teaspoonfuls in a 24-hour period, and you should not use the maximum dosage for more than 2 weeks.

If the patient is a child under 12 years old, it’s best to consult a doctor before giving them this medication. Always follow the guidance provided by your healthcare professional to ensure safe and effective use.

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

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 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

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep your medications in a safe place and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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 have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, the recommended dosage is 2 to 4 teaspoonfuls taken between meals or at bedtime, unless your doctor advises otherwise.

Be cautious not to exceed 16 teaspoonfuls 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 the safety and well-being of your child.

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 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 some over-the-counter medications, like antacids, can interact with certain prescription drugs. This means that taking them together might affect how well your medications work. Since there are no specific drug interactions or laboratory test interactions listed for your medications, it’s still crucial to discuss all the medications and supplements you are taking with your healthcare provider.

By having this conversation, you can ensure that your treatment is safe and effective, and that you avoid any potential issues. Always keep your healthcare team informed about everything you’re taking to help them provide the best care for you.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to protect it from freezing, as extreme cold can damage it. Always keep the container tightly closed when not in use to maintain its integrity and safety. Following these simple guidelines will help you use the product effectively and safely.

Additional Information

For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls taken between meals or at bedtime, or as directed by your doctor. It's important not to exceed 16 teaspoonfuls in a 24-hour period, and you should not use the maximum dosage for more than 2 weeks. If you are considering this medication for a child under 12, please consult a doctor first.

FAQ

What is Melox used for?

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

What should I do before using Melox?

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

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

Take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor, but do not exceed 16 teaspoonfuls in a 24-hour period.

Can children under 12 use Melox?

Children under 12 should ask a doctor 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.

Is Melox safe to use during pregnancy or breastfeeding?

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

How should I store Melox?

Store at room temperature, protect from freezing, and keep tightly closed.

Are there any known drug interactions with Melox?

Antacids like Melox may interact with certain prescription drugs, so consult a doctor or pharmacist if you are taking other medications.

Packaging Info

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

Packaging configurations for Melox.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

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

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

Dosage and Administration

Healthcare professionals should instruct patients to shake the medication well before each use. For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls taken between meals, at bedtime, or as directed by a physician. It is important to note that the maximum dosage should not exceed 16 teaspoonfuls within a 24-hour period, and this maximum dosage should not be used for more than 2 weeks.

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

Contraindications

Use of this product is contraindicated in children due to the risk of accidental ingestion. It should be kept out of reach of children to prevent potential harm. 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 for individuals taking prescription medications to seek guidance from a doctor or pharmacist, as antacids may interact with certain drugs, potentially affecting their efficacy or safety.

In the event that symptoms persist for more than two weeks, it is imperative to 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 for both mother and child.

To ensure safety, this product should be stored out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be advised to consult a healthcare professional prior to use if they have kidney disease or are on a magnesium-restricted diet. Additionally, it is important 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.

In the event that symptoms persist for more than two weeks, patients are instructed to discontinue use and consult a healthcare provider. Pregnant or breastfeeding individuals should also seek advice from a health professional before using this product to ensure safety for both themselves and their child.

Drug Interactions

Antacids may interact with certain prescription medications, potentially affecting their absorption and efficacy. It is advisable for healthcare professionals to monitor patients closely when antacids are co-administered with other drugs. Specific dosage adjustments may be necessary depending on the individual medication involved and the clinical scenario.

No additional drug interactions or laboratory test interactions have been identified.

Packaging & NDC

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

Packaging configurations for Melox.
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 2 to 4 teaspoonfuls taken between meals, at bedtime, or as directed by a physician. It is important to note that the maximum dosage should not exceed 16 teaspoonfuls within a 24-hour period, and this maximum dosage should not be used for more than 2 weeks.

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

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 drug 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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be warranted to guide management decisions.

It is crucial for healthcare professionals to document all findings and interventions thoroughly and to report any adverse events related to overdosage to the appropriate regulatory authorities.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any relevant nonclinical toxicology data. Additionally, no details are provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 potential risks associated with children accessing the medication, including serious health consequences. 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 configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from freezing conditions. Additionally, it is essential to keep the container tightly closed to maintain the integrity of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 to 4 teaspoonfuls of the medication between meals, at bedtime, or as directed by a healthcare professional. It is important not to exceed 16 teaspoonfuls within a 24-hour period or to use the maximum dosage for more than 2 weeks. For children under 12 years of age, consultation with a doctor is recommended prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Melox, 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 Melox, 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.