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Soothe

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Active ingredient
Calcium Carbonate 400 mg
Other brand names
Drug classes
Blood Coagulation Factor, Phosphate Binder
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 2018
Label revision date
March 8, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 400 mg
Other brand names
Drug classes
Blood Coagulation Factor, Phosphate Binder
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 2018
Label revision date
March 8, 2025
Manufacturer
Walgreen Company
Registration number
M001
NDC root
0363-5960
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

Children's Soothe® is a chewable antacid that contains 400 mg of calcium carbonate, designed specifically for children aged 2 to 11 years. With a pleasant bubble gum flavor, it helps relieve common digestive discomforts such as heartburn, acid indigestion, sour stomach, and upset stomach associated with these symptoms.

This product comes in a package of 24 chewable tablets, which should be chewed or crushed completely before swallowing. Children's Soothe® offers a gentle and effective way to help your child feel better when they experience these uncomfortable digestive issues.

Uses

If you're experiencing discomfort from heartburn, acid indigestion, or a sour stomach, this medication can help relieve those symptoms. It’s also effective for upset stomachs that are 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 dosing chart based on weight, which is preferred, or age if weight isn’t available. For children aged 2 to 5 years who weigh between 24 and 47 pounds, the recommended dose is 1 chewable tablet. For those aged 6 to 11 years who weigh between 48 and 95 pounds, the dose is 2 chewable tablets. If your child is under 2 years old and weighs less than 24 pounds, it’s best to consult a doctor for guidance.

When taking the chewable tablets, make sure to chew or crush them completely before swallowing; do not swallow them whole. You can repeat the dose as needed, but be cautious not to exceed the maximum limit: no more than 3 chewable tablets for children aged 2 to 5 years, and no more than 6 chewable tablets for those aged 6 to 11 years within a 24-hour period. Additionally, avoid using the maximum dosage for more than two weeks unless directed by a doctor.

What to Avoid

It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications or concerns about abuse, misuse, or dependence, you should stop using the medication and consult your doctor if your symptoms persist for more than two weeks. This ensures that you receive the appropriate care and support for your health needs. Always prioritize your well-being and seek professional advice when necessary.

Side Effects

It's important to be aware of potential interactions and side effects when using this medication. If your child is currently taking any prescription drugs, please consult with a doctor or pharmacist before use, as antacids can interact with certain medications.

You should also stop using the medication and seek medical advice if symptoms persist for more than two weeks. This ensures that any underlying issues can be properly addressed.

Warnings and Precautions

Before using this medication, it's important to consult with your doctor or pharmacist, especially if your child is currently taking any prescription drugs, as antacids can interact with certain medications.

If your symptoms persist for more than two weeks, you should stop taking the medication and reach out to your doctor for further guidance. While there are no specific emergency instructions provided, always seek immediate medical help if you experience severe or concerning symptoms.

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, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.

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 about your health and the health of 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, it's important to know that there is no specific information available about the use of this product in nursing mothers. Additionally, there are no details regarding whether this product can pass into breast milk or any precautions you should take while breastfeeding.

Given this lack of information, it may be wise to consult with your healthcare provider to discuss any concerns or questions you have about using this product while nursing. Your health and the well-being of your baby are paramount, so seeking professional advice can help you make informed decisions.

Pediatric Use

Before giving this medication to your child, it's important to consult with a doctor or pharmacist, especially if they are currently taking any prescription drugs, as some medications can interact with antacids. For children aged 2 to 11 years, you can find the appropriate dose based on their weight. For example, children under 24 pounds (under 2 years) should not use this medication without a doctor's advice. Those weighing between 24 and 47 pounds (ages 2-5) can take 1 chewable tablet, while children weighing 48 to 95 pounds (ages 6-11) can take 2 tablets.

Make sure your child chews or crushes the tablets completely before swallowing, and do not exceed the maximum dosage of 3 tablets for ages 2-5 or 6 tablets for ages 6-11 in a 24-hour period. If your child's symptoms persist for more than two weeks, stop use and consult a doctor. Always keep this and all medications out of reach of children to ensure their safety.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney 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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and appropriate for your kidney health.

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 may affect how well those medications work.

To ensure your safety and the effectiveness of your treatments, 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 of 25°C (77°F). It’s acceptable for the temperature to vary between 15°-30°C (59°-86°F), but try to avoid exposing it to excessive humidity, as this can affect its quality.

Always check the end flap for the expiration date and lot number to ensure you are using the product safely and effectively. Proper storage and handling are key to maintaining the integrity of the device.

Additional Information

You should take this medication orally. If your child is currently taking any prescription drugs, it's important to consult with a doctor or pharmacist before using this medication, as antacids can interact with some prescription medications. If symptoms persist for more than two weeks, stop using the medication and seek medical advice. Always keep this and all other medications out of the reach of children to ensure their safety.

FAQ

What is Children's Soothe®?

Children's Soothe® is a chewable antacid containing 400 mg of calcium carbonate, designed to relieve heartburn, acid indigestion, sour stomach, and upset stomach in children.

What age group is Children's Soothe® recommended for?

It is recommended for children aged 2 to 11 years.

How should I take Children's Soothe®?

You should chew or crush the tablets completely before swallowing; do not swallow them whole.

What is the maximum dosage for Children's Soothe®?

Do not take more than 3 chewable tablets if your child is aged 2-5 years, or 6 chewable tablets if aged 6-11 years, in a 24-hour period.

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

You should stop using Children's Soothe® and ask a doctor if symptoms last more than two weeks.

Can Children's Soothe® interact with other medications?

Yes, you should ask a doctor or pharmacist before use if your child is currently taking a prescription drug, as antacids may interact with certain medications.

Is there any information about using Children's Soothe® during pregnancy or breastfeeding?

The insert does not provide specific information regarding the use of this product during pregnancy or breastfeeding.

How should I store Children's Soothe®?

Store Children's Soothe® at 25°C (77°F), with permitted excursions between 15°-30°C (59°-86°F), and avoid excessive humidity.

What flavor does Children's Soothe® come in?

Children's Soothe® is available in a bubble gum flavor.

What should I do if the safety seal is broken or missing?

Do not use Children's Soothe® if the imprinted safety seal under the cap is broken or missing.

Packaging Info

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

Packaging configurations for Soothe.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children's Soothe® is a chewable antacid formulation containing 400 mg of calcium carbonate per tablet. It is designed for the relief of heartburn, sour stomach, and acid indigestion in children aged 2 to 11 years. The product is presented in a bubble gum flavor and is packaged in a bottle containing 24 chewable tablets. Each tablet must be chewed or crushed completely before swallowing; swallowing whole tablets is not recommended. The product features a tamper-evident safety seal under the cap, which should not be broken or missing prior to use. It is distributed by Walgreen Co., located at 200 Wilmot Rd., Deerfield, IL 60015. The National Drug Code (NDC) for this product is 0363-5960-08.

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, which is the preferred method. If weight is not available, age may be used as an alternative.

For patients weighing under 24 pounds or under 2 years of age, it is recommended to consult a doctor for the appropriate dosage. For patients weighing between 24 and 47 pounds (ages 2-5), the recommended dose is 1 chewable tablet. For those weighing between 48 and 95 pounds (ages 6-11), the recommended dose is 2 chewable tablets.

Patients should chew or crush the tablets completely before swallowing; the tablets should not be swallowed whole. Doses may be repeated as needed, but it is important to adhere to the following maximum limits: do not exceed 3 chewable tablets for patients aged 2-5 or 6 chewable tablets for patients aged 6-11 within a 24-hour period. Additionally, the maximum dosage should not be used for more than two weeks unless advised and supervised by a doctor.

Contraindications

There are no contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if symptoms persist for more than two weeks.

Warnings and Precautions

Healthcare professionals should advise patients to consult with a physician or pharmacist prior to use if the child is currently taking any prescription medications, as antacids may interact with certain drugs.

Patients should be instructed to discontinue use and seek medical advice if symptoms persist for more than two weeks. This precaution is essential to ensure that any underlying conditions are appropriately evaluated and managed.

Currently, there are no specific instructions regarding emergency medical assistance or general precautions that need to be highlighted. Additionally, there are no laboratory tests recommended for monitoring in relation to the use of this product.

Side Effects

Patients should be advised to consult a doctor or pharmacist prior to use if they are currently taking a prescription medication, as antacids may interact with certain prescription drugs.

In the event that symptoms persist for more than two weeks, patients are instructed to discontinue use and seek medical advice. This precaution is essential to ensure the safety and efficacy of treatment, as prolonged symptoms may indicate an underlying condition that requires further evaluation.

Drug Interactions

Antacids may interact with various prescription medications, potentially affecting their absorption and efficacy. It is advisable to separate the administration of antacids and other medications by at least two hours to minimize the risk of interaction. Monitoring for therapeutic effectiveness of the affected medications is recommended when antacids are used concurrently.

Packaging & NDC

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

Packaging configurations for Soothe.
Details

Pediatric Use

Pediatric patients aged 2 to 11 years are indicated for use of this product. It is essential to consult a doctor or pharmacist before administration if the child is currently taking any prescription medications, as antacids may interact with certain drugs.

Dosing should be determined based on weight; however, age may be used if weight is not available. The recommended dosages are as follows: for children weighing under 24 lb and under 2 years of age, consultation with a doctor is advised. For those weighing between 24-47 lb (ages 2-5 years), the recommended dose is 1 chewable tablet. For children weighing 48-95 lb (ages 6-11 years), the recommended dose is 2 chewable tablets.

Tablets should be chewed or crushed completely before swallowing; they must not be swallowed whole. Pediatric patients should not exceed 3 chewable tablets in a 24-hour period for ages 2-5 years, or 6 chewable tablets for ages 6-11 years. Additionally, the maximum dosage should not be used for more than two weeks unless under the advice and supervision of a doctor.

Parents and caregivers should monitor the child’s symptoms and discontinue use if symptoms persist for more than two weeks. It is crucial to keep this and all medications out of the reach of children.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

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 concerns with patients and consider alternative therapies where appropriate.

Lactation

There is no specific information available regarding the use of this product in lactating mothers. Additionally, there is no data on the potential for excretion in breast milk or any precautions that should be taken for breastfeeding women. Healthcare professionals should consider the lack of information when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent, provided there are no contraindications.

Further management should be guided by the clinical scenario and may involve specific antidotes or interventions as indicated. Continuous assessment and supportive measures are critical in ensuring patient safety and optimizing outcomes in cases of overdose.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of the reach of children to prevent accidental ingestion.

Patients should be informed to discontinue use and consult a doctor if their symptoms persist for more than two weeks, as this may indicate a need for further evaluation or a change in treatment strategy.

Additionally, it is important for healthcare providers to recommend that patients consult with a doctor or pharmacist before using this medication if the child is currently taking any prescription drugs. This is particularly crucial as antacids may interact with certain prescription medications, potentially affecting their efficacy or safety.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). Care should be taken to avoid excessive humidity during storage. For additional information regarding the expiration date and lot number, please refer to the end flap of the packaging.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to consult a doctor or pharmacist prior to use if the child is currently taking a prescription drug, as antacids may interact with certain medications. Patients are also instructed to discontinue use and seek medical advice if symptoms persist for more than two weeks. It is essential to keep this and all medications out of the reach of children.

Drug Information (PDF)

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