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Ko-Lanta

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Active ingredients
  • Dimethicone 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 2020
Label revision date
March 31, 2025
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
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 2020
Label revision date
March 31, 2025
Manufacturer
Geri-Care Pharmaceuticals, Corp
Registration number
M001
NDC root
57896-004
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 find this medication helpful if you experience discomfort from heartburn, sour stomach, acid indigestion, or gas. It works by relieving these symptoms, providing you with a sense of comfort and relief from digestive issues. If you're looking for a solution to these common stomach problems, this medication could be a suitable option for you.

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 can take 2 to 4 teaspoonfuls between meals or at bedtime, unless your doctor advises otherwise. However, it’s important not to exceed 24 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

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you.

Side Effects

It's important to be aware of potential side effects and interactions 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 the medication works for you. Additionally, if you are currently taking any prescription drugs, it's wise to check with your doctor or pharmacist, as antacids can interact with certain medications.

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 currently 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 the specific signs of an overdose are not detailed, common 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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

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 old should consult a doctor before use. For those aged 12 and older, the recommended dosage is 2 to 4 teaspoonfuls taken between meals, at bedtime, or as directed by a healthcare professional.

Be mindful of the maximum dosage: no one should take more than 24 teaspoonfuls in a 24-hour period, and it's advised not to use the maximum dosage for more than 2 weeks. Always prioritize safety and consult with a healthcare provider if you have any questions or concerns about your child's health.

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 (a condition affecting how well your kidneys filter waste) or if you are currently taking any prescription drugs. Some medications, including antacids, can interact with your prescriptions, so it's wise to check with a healthcare professional.

For adults and children aged 12 and older, the recommended dosage is 2 to 4 teaspoonfuls taken between meals or at bedtime, unless directed otherwise by a doctor. Be cautious not to exceed 24 teaspoonfuls 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 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 tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be aware that antacids can interact with some prescription medications. This means that if you are currently taking any prescription drugs, you should consult with your doctor or pharmacist before using antacids. They can help ensure that your medications work effectively and safely together.

Always keep open communication with your healthcare provider about all the medications and supplements you are taking. This way, you can avoid any potential interactions and ensure the best possible care for your health.

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

You should take this medication orally. Before using it, consult your doctor if you have kidney disease or are on a magnesium-restricted diet. It's also important to check with your doctor or pharmacist if you are currently taking any prescription medications. If your symptoms persist for more than two weeks, stop using the medication and seek medical advice. If you are pregnant or breastfeeding, talk to a health professional before use. Remember to 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 and older should take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor.

What is the maximum dosage I can take in 24 hours?

You should not take more than 24 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks.

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

You should stop use and ask a doctor if symptoms last more than 2 weeks.

Are there any warnings I should be aware of?

Yes, ask a doctor before use if you have kidney disease or a magnesium-restricted diet, and consult a doctor or pharmacist if you are taking a prescription drug.

What should I do if I am pregnant or breastfeeding?

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

How should I store this drug?

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

What should I do if I have children under 12 years?

You should ask a doctor before use if the patient is under 12 years old.

Is there any specific information regarding drug interactions?

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

Packaging Info

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

Packaging configurations for Ko-Lanta.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The provided data does not include specific details regarding the chemical name, physical characteristics, or inactive ingredients of the drug. As such, a comprehensive description cannot be formulated. Further information is required to accurately convey the drug's properties and characteristics.

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

Healthcare professionals should instruct patients to shake the product well before 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 patients should not exceed a maximum of 24 teaspoonfuls within a 24-hour period, and the maximum dosage should not be used for more than 2 consecutive weeks.

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

Contraindications

There are no contraindications listed for this product. It is important to evaluate individual patient circumstances and consult relevant clinical guidelines when considering its use.

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, patients are advised to discontinue use and consult a healthcare provider. Additionally, pregnant or breastfeeding individuals should seek professional advice before using this product.

To ensure safety, this product should be kept out of reach of children.

Side Effects

Patients should be aware of certain warnings associated with the use of this medication. It is advised to consult a doctor before use if there is a history of kidney disease or if the patient is on a magnesium-restricted diet. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking any prescription medications, as antacids may interact with specific drugs.

In the event that symptoms persist for more than two weeks, patients are instructed to discontinue use and consult a doctor. Furthermore, it is recommended that pregnant or breastfeeding individuals consult a health professional prior to using this medication.

Drug Interactions

Antacids have the potential to interact with various prescription medications. It is advisable for patients to consult with a healthcare professional, such as a doctor or pharmacist, prior to using antacids if they are currently taking any prescription drugs. This precaution helps to ensure safe and effective use, minimizing the risk of adverse interactions.

Packaging & NDC

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

Packaging configurations for Ko-Lanta.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents 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 healthcare provider.

It is important to note that the maximum dosage should not exceed 24 teaspoonfuls 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 if they have kidney disease, as this may affect 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, particularly with antacids.

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 healthcare professional. It is crucial for elderly patients to adhere to the maximum dosage guidelines, which stipulate that no more than 24 teaspoonfuls should be taken 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 essential to consult a doctor before administration. Careful monitoring and adherence to these recommendations are important to ensure the safety of 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 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.

Should an overdosage occur, the management approach should include supportive care tailored to the patient's clinical presentation. Healthcare providers are encouraged to implement standard emergency protocols, which may involve the following steps:

  1. Assessment of Symptoms: Continuous monitoring for any potential symptoms associated with overdosage is critical. Symptoms may vary based on the individual and the extent of the overdose.

  2. Supportive Care: Initiate supportive measures as necessary, which may include maintaining airway patency, providing supplemental oxygen, and ensuring hemodynamic stability.

  3. Consultation with Poison Control: In cases of suspected overdosage, it is advisable to contact a poison control center for guidance on specific management strategies and potential antidotes, if applicable.

  4. Documentation and Reporting: Document the incident thoroughly, including the amount ingested, time of ingestion, and any interventions performed. Reporting the overdosage to relevant health authorities may also be warranted.

Healthcare professionals should remain vigilant and prepared to respond to any signs of overdosage, ensuring patient safety and effective management of the situation.

Nonclinical Toxicology

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

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.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature, away from extreme temperatures. It is essential to protect the product from freezing to maintain its integrity. Additionally, the container must be kept tightly closed to prevent contamination and preserve the quality of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to consult a doctor before use if they have kidney disease or are on a magnesium-restricted diet. Additionally, patients should seek guidance from a healthcare professional if they are currently taking a prescription drug. If symptoms persist for more than two weeks, patients are instructed to discontinue use and consult a doctor. Pregnant or breastfeeding individuals should also seek professional advice prior to use. It is important to keep the medication out of reach of children.

Drug Information (PDF)

This file contains official product information for Ko-Lanta, 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 Ko-Lanta, 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.