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Melox

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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
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 2023
Label revision date
October 4, 2024
Drug Information (PDF)
Prescribing information, PDF file
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
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 2023
Label revision date
October 4, 2024
Manufacturer
Belmora LLC
Registration number
M001
NDC root
27854-117
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-117 is a medication designed to help relieve discomfort caused by acid indigestion, heartburn, sour stomach, upset stomach, and gas associated with these symptoms. It works by addressing the underlying causes of these digestive issues, providing you with relief and comfort when you need it most. If you're experiencing any of these common stomach problems, Melox-117 may be a suitable option to consider for alleviating your discomfort.

Uses

If you're experiencing discomfort from acid indigestion, heartburn, or a sour stomach, this medication can help relieve those symptoms. It is also effective for upset stomach and gas that may accompany these issues.

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.

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 to 20 milliliters (mL) four times a day, unless your doctor has given you different instructions.

If the patient is a child under 12 years old, it’s important to consult a doctor for the appropriate dosage. Always follow your healthcare provider's guidance to ensure safe and effective use of the medication.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular conditions or situations in which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

Taking this medication can lead to some side effects, and it's important to be aware of them. You should not exceed 80 mL in a 24-hour period or use the maximum dosage for more than two weeks without consulting your doctor. If you have kidney disease or are on a magnesium-restricted diet, it's essential to talk to your doctor before using this product. Additionally, if you are currently 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 consult your doctor. Always prioritize your health and safety by following these guidelines.

Warnings and Precautions

It's important to use this product safely. Do not exceed 80 mL in a 24-hour period, and avoid using the maximum dosage for more than two weeks unless your doctor advises you otherwise. If you have kidney disease or are on a magnesium-restricted diet, consult your doctor before using this product. Additionally, if you are currently 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 product and contact your doctor for further guidance. Always prioritize your health and seek professional advice when needed.

Overdose

Taking more than 80 mL of this product 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 symptoms that could affect your health. If you suspect an overdose, it’s important to seek immediate medical help.

If you experience any concerning symptoms or if you have taken too much, contact your healthcare provider or local emergency services right away. Always prioritize your safety and well-being by following dosage instructions carefully.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you understand any potential risks and make informed decisions that are best for you and your baby. Always prioritize open communication with your doctor regarding any medications or treatments during this important time.

Lactation Use

If you are breastfeeding or planning to breastfeed, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider about any concerns you may have regarding your health and breastfeeding.

Pediatric Use

If you have a child under 12 years old, it's important to consult a doctor before using this medication. For children aged 12 and older, the recommended dosage is 10 to 20 mL taken four times a day, or as directed by a healthcare professional. Always follow your doctor's advice to ensure the safety and effectiveness of the treatment for your child.

Geriatric Use

If you are an older adult or caring for one, it's important to consult with a doctor before using this medication, especially if you have kidney disease or are following a magnesium-restricted diet. These conditions can affect how your body processes the medication and may require special attention.

For adults and children aged 12 and older, the typical dosage is 10 to 20 mL taken four times a day, or as directed by your healthcare provider. If the patient is under 12 years old, please consult a doctor for appropriate guidance. Always prioritize safety and seek professional advice to ensure the best care.

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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 best performance of your product, store it at a temperature between 20°C and 25°C (68°F and 77°F). It's important to keep it in a cool, dry place and avoid freezing, as this can damage the product.

When handling the product, make sure to maintain a clean environment to prevent contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the effectiveness of the product.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dose is 10 to 20 mL four times a day, or as directed by your doctor. If the patient is under 12 years old, it's important to consult a doctor for the appropriate dosage.

FAQ

What is Melox-117 used for?

Melox-117 relieves acid indigestion, heartburn, sour stomach, upset stomach, and gas associated with these symptoms.

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

Adults and children 12 years and older should take 10 - 20 mL four times a day, or as directed by a doctor.

What should children under 12 do before using Melox-117?

Children under 12 years should consult a doctor before use.

Are there any warnings associated with Melox-117?

Do not take more than 80 mL in a 24-hour period or use the maximum dosage for more than 2 weeks without a doctor's advice. Consult a doctor if you have kidney disease or are on a magnesium-restricted diet.

Is Melox-117 safe to use during pregnancy?

The insert does not provide specific information regarding the use of Melox-117 during pregnancy.

Can Melox-117 be used by nursing mothers?

There are no specific warnings or recommendations regarding the use of Melox-117 by nursing mothers.

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

You should stop using Melox-117 and consult a doctor if your symptoms last more than two weeks.

How should Melox-117 be stored?

Store Melox-117 at 20°C-25°C (68°F-77°F) and do not freeze.

What should I do if I am taking prescription drugs?

Ask a doctor or pharmacist before using Melox-117, as antacids may interact with certain prescription drugs.

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

Melox-117 is a pharmaceutical compound characterized by its specific chemical properties and formulation. The molecular weight of Melox-117 is not specified in the provided data. The chemical formula is also not detailed. The drug is available in a dosage form suitable for its intended therapeutic use. Further information regarding its appearance and inactive ingredients is not included in the extracted facts.

Uses and Indications

This drug is indicated for the relief of symptoms associated with acid indigestion, heartburn, sour stomach, and upset stomach, including gas related to these conditions.

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

Dosage and Administration

Healthcare professionals are advised to instruct patients to shake the product well before use.

For adults and children aged 12 years and older, the recommended dosage is 10 to 20 mL administered four times a day, or as directed by a physician.

For children under 12 years of age, it is essential to consult a healthcare provider for appropriate dosing recommendations.

All dosages should be measured accurately in milliliters (mL).

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Patients should not exceed a maximum dosage of 80 mL within a 24-hour period, nor should they use this product for more than two weeks without the guidance and supervision of a healthcare professional.

Pre-existing Conditions Prior to use, individuals with kidney disease or those on a magnesium-restricted diet should consult a physician. These conditions may influence the safety and efficacy of the product.

Drug Interactions It is imperative for patients to seek advice from a healthcare provider or pharmacist before using this product if they are currently taking any prescription medications. Antacids have the potential to interact with certain prescription drugs, which may lead to adverse effects or reduced therapeutic efficacy.

Duration of Use Patients are advised to discontinue use and consult a healthcare professional if symptoms persist beyond two weeks. Prolonged use without medical supervision may necessitate further evaluation and management.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals with pre-existing conditions. It is advised that patients do not exceed a dosage of 80 mL within a 24-hour period or use the maximum dosage for more than two weeks without the guidance and supervision of a healthcare professional.

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

In the event that symptoms persist for more than two weeks, patients are advised to discontinue use and consult a doctor. Monitoring for these adverse reactions is essential to ensure patient safety and effective management of their health conditions.

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. Patients should be counseled to separate the dosing of antacids and other prescribed drugs by at least two hours when possible to ensure optimal therapeutic outcomes.

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 10 to 20 mL taken four times a day, or as directed by a healthcare provider.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have a history of kidney disease, as this may necessitate careful monitoring and potential dosage adjustments. Additionally, those on a magnesium-restricted diet are advised to seek medical advice before initiating treatment, given the potential for interactions or contraindications.

For dosing, the recommended administration for adults and children aged 12 years and older is 10 to 20 mL four times a day, or as directed by a healthcare professional. It is important to note that for children under 12 years of age, consultation with a healthcare provider is essential to determine the appropriate dosage and ensure safety.

Healthcare providers should remain vigilant in monitoring geriatric patients for any adverse effects or complications that may arise during treatment, particularly in those with pre-existing health conditions.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, the safety concerns, dosage modifications, or special precautions for pregnant patients remain undefined. Healthcare professionals should exercise caution when considering this product for women of childbearing potential and weigh the potential risks against the benefits. It is advisable to discuss any potential implications with patients who are pregnant or planning to become pregnant.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

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 cases of overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. The maximum allowable dosage is 80 mL within a 24-hour period. Additionally, the product should not be used at its maximum dosage for more than 2 weeks unless directed by a healthcare professional.

Healthcare providers should be vigilant for symptoms that may arise from overdosage, although specific symptoms are not detailed in the provided information. In the event of suspected overdosage, it is advisable to seek immediate medical attention.

Management of overdosage should involve supportive care and monitoring of the patient’s condition. Healthcare professionals are encouraged to consult relevant medical guidelines and toxicology resources for further management strategies tailored to the specific circumstances of the overdosage event.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this 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 individuals.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20°C to 25°C (68°F to 77°F). Freezing the product is strictly prohibited, as it may compromise its integrity and efficacy. Proper storage conditions must be maintained to ensure the product remains effective and safe for use.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 10 to 20 mL taken four times a day, or as directed by a healthcare professional. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing guidance.

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

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.