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Childrens Tummy Relief

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Active ingredient
Calcium Carbonate 400 mg
Other brand names
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
February 20, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 400 mg
Other brand names
Dosage form
Tablet, Chewable
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 2022
Label revision date
February 20, 2025
Manufacturer
Genexa Inc.
Registration number
M001
NDC root
69676-0060
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

Genexa® Tummy Relief is a children's calcium carbonate antacid designed to help relieve common stomach discomforts. It is specifically formulated for children aged 2 to 11 and works by alleviating symptoms such as heartburn, acid indigestion, sour stomach, and upset stomach associated with these issues.

This product is made without certain additives like talc and artificial colors, and it comes in a pleasant organic berry and vanilla flavor, making it easier for kids to take. Available in chewable tablets, Genexa® Tummy Relief offers a gentle and effective solution for your child's tummy troubles.

Uses

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

You can feel confident using this medication, as there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects reported. This makes it a safe option for managing your digestive discomfort.

Dosage and Administration

To determine the right dose for you or your child, start by checking the weight on the provided chart. If the weight is over 48 pounds and the child is between 6 to 11 years old, they should chew 2 tablets when symptoms arise, but make sure not to exceed 6 tablets in a 24-hour period. For children weighing between 24 to 47 pounds, typically aged 2 to 5 years, the recommended dose is to chew 1 tablet as symptoms occur, with a maximum of 3 tablets in 24 hours.

If your child weighs less than 24 pounds and is under 2 years old, it’s important to consult a doctor for guidance on the appropriate dosage. Remember, the tablets should be chewed whenever symptoms appear, ensuring you follow these guidelines for safe and effective use.

What to Avoid

It's important to use this medication safely, especially when it comes to dosage for children. You should not give a child more than 3 tablets if they are aged 2 to 5 years, or more than 6 tablets if they are aged 6 to 11 years within a 24-hour period. Additionally, avoid giving the maximum dosage for more than 2 weeks unless a doctor has advised and is supervising this treatment.

Always prioritize your child's health by following these guidelines closely to ensure their safety and well-being. If you have any questions or concerns, don't hesitate to reach out to a healthcare professional for guidance.

Side Effects

When using this product, it's important to follow dosage guidelines carefully. For children aged 2 to 5, do not exceed 3 tablets in a 24-hour period, and for those aged 6 to 11, the limit is 6 tablets. Additionally, avoid giving the maximum dosage for more than 2 weeks unless directed by a doctor.

While specific side effects are not listed here, it's essential to be aware that any medication can cause adverse reactions. If you notice any unusual symptoms or if your child experiences severe reactions, contact a healthcare professional immediately. Always prioritize safety and consult with a doctor if you have any concerns.

Warnings and Precautions

Before giving this product to your child, it's important to consult with a doctor or pharmacist, especially if they are currently taking any prescription medications, as antacids can interact with some of these drugs.

When using this product, please ensure that you do not exceed the recommended dosage: for children aged 2 to 5, do not give more than 3 tablets in a 24-hour period, and for those aged 6 to 11, the limit is 6 tablets. Additionally, avoid giving the maximum dosage for more than 2 weeks unless directed by a doctor.

While there are no specific lab tests required for this product, always stay vigilant and monitor your child’s response to the medication. If you notice any unusual symptoms or have concerns, it’s best to consult your healthcare provider.

Overdose

If you suspect that a child has taken too much medication, it's important to know the signs of an overdose. Symptoms can include unusual drowsiness, difficulty breathing, or any other unexpected changes in behavior. If you notice any of these signs, seek immediate medical help.

To prevent an overdose, make sure not to give a child more than 3 tablets if they are aged 2 to 5, or more than 6 tablets if they are aged 6 to 11 within a 24-hour period. Additionally, avoid giving the maximum dosage for more than 2 weeks unless a doctor has advised you to do so. Always follow dosing instructions carefully to ensure the safety and well-being of your child.

Pregnancy Use

When considering the use of Children's Tummy Relief (calcium carbonate chewable tablets) during pregnancy, it's important to note that there is no specific information available about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this medication on pregnancy have not been clearly studied or established.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before taking any medication, including over-the-counter options like Children's Tummy Relief. They can help you weigh the potential benefits and risks based on your individual health needs.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is no specific information available about the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since the insert does not provide guidance on these topics, it may be wise to consult your healthcare provider for personalized advice. They can help you understand any potential risks and make informed decisions about your health and your baby's well-being.

Pediatric Use

When giving this medication to your child, it's important to follow specific guidelines based on their age and weight. For children aged 2 to 5 years, do not exceed 3 tablets in a 24-hour period, and for those aged 6 to 11 years, the limit is 6 tablets. If your child needs the maximum dosage for more than 2 weeks, consult a doctor for advice and supervision.

For dosing based on weight, children who weigh over 48 lbs (typically ages 6-11) can chew 2 tablets as needed, but should not exceed 6 tablets in a day. For those weighing between 24 and 47 lbs (ages 2-5), they should chew 1 tablet as symptoms occur, with a maximum of 3 tablets in 24 hours. If your child weighs under 24 lbs (younger than 2 years), please consult a doctor before administering the medication.

Geriatric Use

When considering Children's Tummy Relief (calcium carbonate tablet, chewable) for older adults, it's important to note that the drug insert does not provide specific information about its use in this age group. This means that there may not be established guidelines or dosage recommendations tailored for older adults.

If you are caring for an older adult, it's essential to consult with a healthcare professional before starting this medication. They can help determine if it's appropriate based on individual health needs and any other medications being taken. Always prioritize safety and ensure that any treatment plan is suitable for the unique considerations of older adults.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if your child is currently taking any prescription drugs. Some medications, like antacids, can interact with these prescriptions, potentially affecting how well they work or causing unwanted side effects.

Always keep your healthcare provider informed about all medications your child is taking to ensure their safety and the effectiveness of their treatment.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a dry place at a temperature between 20-25°C (68-77°F), away from direct sunlight. This helps maintain its quality and performance.

When handling the product, pay attention to the bottle's safety seal, which is a perforated band around the bottle. If this seal is disturbed or missing, do not use the product, as it may indicate that the contents are compromised. Always prioritize these storage and handling guidelines to ensure your safety and the product's integrity.

Additional Information

You should take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is Genexa® Tummy Relief?

Genexa® Tummy Relief is a children's calcium carbonate antacid designed to relieve heartburn, acid indigestion, sour stomach, and upset stomach.

What age group is Genexa® Tummy Relief intended for?

It is intended for children ages 2 to 11.

What flavors does Genexa® Tummy Relief come in?

It is available in Organic Berry and Vanilla flavors, as well as a chewable Bubblegum flavor.

How should I administer Genexa® Tummy Relief?

You should chew the tablets as symptoms occur, following the dosage guidelines based on your child's weight.

What is the maximum dosage for children aged 2-5 years?

Children aged 2-5 years should not exceed 3 tablets in 24 hours.

What is the maximum dosage for children aged 6-11 years?

Children aged 6-11 years should not exceed 6 tablets in 24 hours.

What should I do if my child is taking other medications?

You should ask a doctor or pharmacist before use, as antacids may interact with certain prescription drugs.

Are there any teratogenic effects associated with Genexa® Tummy Relief?

No teratogenic effects are mentioned for this product.

How should I store Genexa® Tummy Relief?

Store it between 20-25°C (68-77°F) in a dry place out of direct sunlight.

What should I do if the bottle seal is disturbed or missing?

Do not use the product if the bottle seal is disturbed or missing.

Packaging Info

Below are the non-prescription pack sizes of Childrens Tummy Relief (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Tummy Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children's Genexa® Medicine Made Clean is formulated for children aged 2 to 11 years and provides relief for various gastrointestinal discomforts, including heartburn, sour stomach, acid indigestion, and upset stomach. The active ingredient, calcium carbonate, serves as an antacid. This product is available in chewable tablet form, featuring a bubblegum flavor enhanced with organic berry and vanilla notes. Each bottle contains 30 chewable tablets and is manufactured without the inclusion of talc, D&C red no. 27 aluminum lake, sorbitol, and other additives. This formulation is comparable to the active ingredient found in Pepto Bismol® Kids.

Uses and Indications

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

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

Dosage and Administration

Healthcare professionals should determine the appropriate dosage based on the patient's weight, with age as an alternative consideration when weight is not available.

For patients weighing over 48 lbs, specifically those aged 6 to 11 years, the recommended dosage is to chew 2 tablets as symptoms occur, with a maximum limit of 6 tablets within a 24-hour period.

For patients weighing between 24 and 47 lbs, typically aged 2 to 5 years, the advised dosage is to chew 1 tablet as symptoms occur, not exceeding 3 tablets in a 24-hour timeframe.

For patients weighing under 24 lbs, particularly those under 2 years of age, it is essential to consult a physician for appropriate dosing guidance.

The tablets should be chewed as symptoms arise to ensure effective administration.

Contraindications

Use is contraindicated in children under the age of 2 years. Additionally, do not exceed a dosage of 3 tablets in 24 hours for children aged 2 to 5 years, or 6 tablets for children aged 6 to 11 years. Prolonged use at maximum dosage for more than 2 weeks is contraindicated unless advised and supervised by a healthcare professional.

Warnings and Precautions

Healthcare professionals should exercise caution when administering this product to children. Prior to use, it is imperative to consult with a physician or pharmacist if the child is currently taking any prescription medications, as antacids may interact with certain drugs.

When utilizing this product, adherence to dosage guidelines is essential. For children aged 2 to 5 years, the maximum dosage should not exceed 3 tablets within a 24-hour period. For those aged 6 to 11 years, the limit is set at 6 tablets in the same timeframe. Furthermore, it is advised that the maximum dosage not be administered for more than 2 weeks unless directed and monitored by a healthcare professional.

Currently, there are no specific laboratory tests recommended for monitoring the use of this product. However, healthcare providers should remain vigilant for any potential interactions or adverse effects associated with concurrent medication use.

Side Effects

Patients using this product may experience adverse reactions, which can vary in seriousness and frequency.

In clinical settings, it is crucial to adhere to the recommended dosage guidelines to minimize the risk of adverse effects. Specifically, caregivers should not administer more than 3 tablets to children aged 2-5 years or 6 tablets to children aged 6-11 years within a 24-hour period. Furthermore, the maximum dosage should not be given for more than 2 weeks unless under the advice and supervision of a healthcare professional.

Failure to follow these guidelines may increase the likelihood of adverse reactions, which can be serious. It is essential for healthcare providers to monitor patients closely and provide appropriate guidance to ensure safe usage of the product.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if the child is currently taking any prescription drugs.

Antacids may have the potential to interact with specific prescription medications, which could alter their effectiveness or increase the risk of adverse effects. It is advisable to monitor for any changes in therapeutic outcomes or side effects when antacids are used concurrently with other prescribed treatments.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Tummy Relief (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Tummy Relief.
Details

Pediatric Use

Pediatric patients aged 2 to 11 years may receive this medication with specific dosage limitations. For children aged 2 to 5 years, the recommended dose is 1 tablet to be chewed as symptoms occur, with a maximum of 3 tablets in a 24-hour period. For those aged 6 to 11 years, the dosage is 2 tablets to be chewed as symptoms occur, not to exceed 6 tablets in 24 hours.

It is important to note that the maximum dosage should not be administered for more than 2 weeks unless directed and supervised by a healthcare professional. For infants and children weighing under 24 lbs (under 2 years), consultation with a doctor is advised before administration.

Geriatric Use

There is no specific information regarding the use of Children's Tummy Relief (calcium carbonate tablet, chewable) in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients.

Given the lack of data, it is advisable to monitor geriatric patients closely for any adverse effects or changes in efficacy. Additionally, healthcare providers may consider evaluating the need for dosage adjustments based on the individual health status and concurrent medications of elderly patients.

Pregnancy

There is no specific information available regarding the use of Children's Tummy Relief (calcium carbonate tablet, chewable) during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There is no specific information available regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

Overdosage

In cases of overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. For children aged 2 to 5 years, the maximum allowable dosage is three tablets within a 24-hour period. For children aged 6 to 11 years, the maximum is six tablets in the same timeframe. Exceeding these limits can lead to potential toxicity and should be avoided.

Furthermore, it is advised that the maximum dosage not be administered for more than two weeks unless under the guidance and supervision of a healthcare professional. Prolonged use at maximum dosage without medical oversight may increase the risk of serious side effects and complications.

In the event of suspected overdosage, healthcare professionals should assess the child for any symptoms of toxicity and initiate appropriate management procedures. Monitoring and supportive care may be necessary, depending on the severity of the symptoms presented. Immediate consultation with a poison control center or medical professional is recommended for further evaluation and treatment.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. When using this product, it is important to inform caregivers not to exceed the recommended dosage: no more than 3 tablets for children aged 2 to 5 years and no more than 6 tablets for children aged 6 to 11 years within a 24-hour period. Additionally, caregivers should be cautioned against administering the maximum dosage for more than 2 weeks unless directed and supervised by a healthcare professional.

Providers should also recommend that caregivers consult with a doctor or pharmacist prior to use if the child is currently taking any prescription medications, as antacids may interact with certain prescription drugs. This precaution is essential to ensure the safety and efficacy of the treatment.

Storage and Handling

The product is supplied in a bottle that is safety sealed with a perforated band around it. It is essential to inspect the seal prior to use; the product should not be used if the bottle seal is disturbed or missing.

For optimal storage, the product must be kept in a dry place at a temperature range of 20-25°C (68-77°F) and protected from direct sunlight. Proper adherence to these storage conditions is crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Childrens Tummy Relief, 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 Childrens Tummy Relief, 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.