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Sound Health Heartburn and Gas Chews

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This product has been discontinued

Active ingredients
  • Dimethicone 80 mg
  • Calcium Carbonate 750 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 2019
Label revision date
November 30, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Dimethicone 80 mg
  • Calcium Carbonate 750 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 2019
Label revision date
November 30, 2024
Manufacturer
BestCo Inc.
Registration number
M001
NDC root
52642-035
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

SoundHealth Mixed Berry is a medication designed to relieve discomfort associated with heartburn, sour stomach, acid indigestion, and upset stomach. It can also help alleviate symptoms like bloating, pressure, or a stuffed feeling, which are commonly referred to as gas. This product aims to provide you with relief from these uncomfortable digestive issues, allowing you to feel more at ease.

Uses

You can use this medication to help relieve various stomach-related issues. It effectively alleviates heartburn, which is that uncomfortable burning sensation in your chest, and it can also help with a sour stomach and acid indigestion. If you're experiencing an upset stomach along with these symptoms, this medication can provide relief.

Additionally, if you're feeling bloated or have a pressure or stuffed feeling often associated with gas, this medication can help ease those discomforts as well. It's designed to make you feel more comfortable and improve your overall digestive experience.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 1 to 2 chews of the medication every 2 to 4 hours as needed. However, it's important not to exceed 5 chews in a 24-hour period to ensure your safety.

If the person needing the medication is under 12 years old, it's best to consult a doctor before giving them any chews. This way, you can ensure they receive the appropriate care and dosage.

What to Avoid

It's important to use this medication responsibly to ensure your safety and well-being. You should not take more than 5 chewable tablets within a 24-hour period. Additionally, avoid using the maximum dosage for longer than 2 weeks unless your doctor has advised you to do so. Following these guidelines helps prevent potential issues and ensures that the medication works effectively for you. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

It's important to be aware of potential side effects when considering this medication. You should not use this product if you have ever experienced an allergic reaction to it or any of its ingredients. Allergic reactions can range from mild symptoms, like rashes, to severe reactions that may require immediate medical attention.

Always consult with your healthcare provider if you have any concerns about allergies or side effects related to this medication. Your safety is a priority, and understanding these warnings can help you make informed decisions about your health.

Warnings and Precautions

You should not use this product if you have ever had an allergic reaction to it or any of its ingredients. Before taking it, consult with your doctor or pharmacist, especially if you are currently on any prescription medications, as antacids can interact with certain drugs.

Be mindful not to exceed 5 chewable tablets in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks unless directed by your physician. If you experience any unusual symptoms or have concerns, it's important to reach out to your healthcare provider for guidance.

Overdose

Taking more than 5 chewable tablets in a 24-hour period, or using the maximum dosage for more than 2 weeks, can lead to an overdose. It's important to follow these guidelines to avoid potential health risks. If you suspect an overdose, look out for signs such as unusual drowsiness, confusion, or difficulty breathing (respiratory depression).

If you experience any of these symptoms or believe you have taken too much, seek immediate medical help. Always consult with your doctor if you have questions about your dosage or if you need to use the medication for an extended period. Your health and safety are the top priority.

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 your child is under 12 years old, it's important to consult a doctor before using this medication. For children aged 12 and older, they can take 1 to 2 chews every 2 to 4 hours as needed, but make sure they do not exceed 5 chews in a 24-hour period. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best course of action based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular monitoring and open communication with your healthcare team are essential for safety and effectiveness.

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, especially if you have concerns about your kidney health. They can provide guidance based on your individual situation.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 might 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 in a dry place at a temperature between 20º to 25ºC (68º to 77ºF). This temperature range helps maintain its effectiveness. After each use, make sure to close the cap tightly to prevent contamination and preserve the integrity of the product.

Handling your product safely is crucial. Always ensure that you are in a clean environment to avoid introducing any unwanted substances. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is SoundHealth Mixed Berry used for?

SoundHealth Mixed Berry relieves heartburn, sour stomach, acid indigestion, upset stomach, bloating, pressure, or a stuffed feeling commonly referred to as gas.

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

You should chew and swallow 1 to 2 chews every 2 to 4 hours as needed, but do not exceed 5 chews in 24 hours.

What should children under 12 do before using this product?

Children under 12 years should consult a doctor before use.

Are there any contraindications for using SoundHealth Mixed Berry?

There are no contraindications listed for this product.

What precautions should I take when using this product?

Ask a doctor or pharmacist before use if you are taking a prescription drug, as antacids may interact with certain medications.

Can I use SoundHealth Mixed Berry if I am pregnant or breastfeeding?

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

What should I do if I have an allergic reaction to this product?

Do not use the product if you have ever had an allergic reaction to it or any of its ingredients.

How should I store SoundHealth Mixed Berry?

Store the product between 20º to 25ºC (68º to 77ºF) in a dry place and close the cap tightly after use.

Packaging Info

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

Packaging configurations for Sound Health Heartburn and Gas Chews.
Details

Drug Information (PDF)

This file contains official product information for Sound Health Heartburn and Gas Chews, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

SoundHealth Mixed Berry HBG is presented in a dosage form containing 82 count units. The product is characterized by its mixed berry flavor profile, designed for specific health applications. Further details regarding its chemical composition and inactive ingredients are not provided in the extracted data.

Uses and Indications

This drug is indicated for the relief of heartburn, sour stomach, and acid indigestion. It is also effective in alleviating upset stomach associated with these symptoms. Additionally, this drug provides relief from bloating, pressure, or the stuffed feeling commonly referred to as gas.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to chew and swallow 1 to 2 chews every 2 to 4 hours as needed. The total daily dosage should not exceed 5 chews within a 24-hour period. For children under 12 years of age, it is recommended to consult a healthcare professional prior to administration.

Contraindications

Use is contraindicated in patients who exceed the recommended dosage of more than 5 chewable tablets within a 24-hour period or who utilize the maximum dosage for longer than 2 weeks without the advice and supervision of a physician. This limitation is essential to prevent potential adverse effects associated with excessive use.

Warnings and Precautions

It is imperative that this product is not used by individuals who have a history of allergic reactions to it or any of its components.

Healthcare professionals should advise patients to consult with a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs.

Patients must adhere to the recommended dosage guidelines, which stipulate that no more than five chewable tablets should be taken within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than two weeks unless directed and monitored by a physician.

No specific laboratory tests are required for the safe use of this product; however, ongoing assessment of the patient's overall health and medication regimen is advisable to prevent potential interactions.

Side Effects

Patients should be aware that the use of this product is contraindicated in individuals who have a history of allergic reactions to this product or any of its ingredients.

In clinical trials and postmarketing experiences, adverse reactions have been reported; however, specific data regarding the frequency or seriousness of these reactions has not been provided. It is essential for patients to consult healthcare professionals for personalized advice and to report any unexpected symptoms or reactions following the use of this product.

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. Specifically, antacids should be taken at least 2 hours apart from other drugs to ensure optimal therapeutic effects and to avoid diminished efficacy of the prescribed medications.

Packaging & NDC

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

Packaging configurations for Sound Health Heartburn and Gas Chews.
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 to chew and swallow 1 to 2 chews every 2 to 4 hours as needed, with a maximum of 5 chews in a 24-hour period.

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.

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 evaluated in these populations to ensure maternal and fetal safety.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

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

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 intake is five chewable tablets within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than two consecutive weeks unless directed by a physician.

Healthcare professionals should be vigilant for potential symptoms of overdosage, which may arise from exceeding these dosage limits. Symptoms can vary based on individual patient factors and the specific circumstances of the overdosage.

Management of overdosage should involve immediate assessment of the patient's condition. If an overdosage is suspected, it is advisable to seek medical attention promptly. Supportive care and symptomatic treatment may be necessary, and healthcare providers should consider consulting a poison control center for further guidance on management strategies tailored to the specific situation.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important for patients to consult with their doctor or pharmacist before using this medication if they are currently taking any prescription drugs, as antacids may interact with certain medications.

Patients should be informed not to exceed a maximum of 5 chewable tablets within a 24-hour period. Additionally, they should not use the maximum dosage for more than 2 weeks unless directed by a physician. This guidance is crucial to ensure safe and effective use of the medication.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product in a dry place at a temperature range of 20º to 25ºC (68º to 77ºF).

To ensure the integrity of the product, it is important to close the cap tightly after each use. Proper adherence to these storage and handling guidelines will help maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Sound Health Heartburn and Gas Chews, 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 Sound Health Heartburn and Gas Chews, 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.