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Legend Premium Heartburn Chewable

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredients
  • Dimethicone 80 mg
  • Calcium Carbonate 750 mg
Other brand names
Dosage form
Tablet
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
June 22, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Dimethicone 80 mg
  • Calcium Carbonate 750 mg
Other brand names
Dosage form
Tablet
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
June 22, 2020
Manufacturer
ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS
Registration number
part331
NDC root
13411-844
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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 be experiencing discomfort from symptoms like acid indigestion, heartburn, or a sour stomach. This medication is designed to provide relief from these issues, as well as from an upset stomach that may accompany them. It can also help alleviate bloating, pressure, or that stuffed feeling often associated with gas.

By targeting these common digestive problems, this medication aims to help you feel more comfortable and at ease. If you're dealing with any of these symptoms, it may be worth considering this option for relief.

Uses

If you're experiencing discomfort from acid indigestion, heartburn, or a sour stomach, this medication can help provide relief. It’s also effective for upset stomachs that come with these symptoms, as well as bloating, pressure, or that uncomfortable stuffed feeling often associated with gas.

You can rely on this treatment to ease your digestive troubles and help you feel more comfortable throughout your day.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 1 or 2 chewable tablets when you experience symptoms, or as your doctor advises. Make sure to chew the tablets completely before swallowing them. However, if you are under 12 years old, it’s important to consult with a doctor before taking any medication.

Remember, you should not exceed 5 chewable tablets in a 24-hour period. This limit helps ensure your safety and the effectiveness of the medication. Always follow the guidance provided by your healthcare professional for the best results.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no known reasons that would prevent you from using it safely. Always remember to consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

You should avoid using this product if you have ever had an allergic reaction to it or any of its ingredients. One common side effect you might experience is constipation. It's important to consult with a doctor or pharmacist before using this product, especially if you are currently taking any prescription medications, as antacids can interact with certain drugs.

Be mindful not to exceed 5 chewable tablets in a 24-hour period, and do not use the maximum dosage for more than 2 weeks unless directed by a physician. If you are pregnant or breastfeeding, please seek advice from a healthcare professional before using this product.

Warnings and Precautions

You should avoid using this product if you have ever had an allergic reaction to it or any of its ingredients. If you are currently taking any prescription medications, it’s important to consult with your doctor or pharmacist before using this product, as it may interact with certain drugs.

While using this product, do not exceed 5 chewable tablets in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks unless directed by a physician. Be aware that constipation may occur as a side effect. If you are pregnant or breastfeeding, please consult a healthcare professional before use. If you experience any severe reactions or symptoms, seek emergency help immediately, and stop using the product and call your doctor if you have any concerns.

Overdose

Taking more than 5 chewable tablets in a 24-hour period can lead to an overdose. It's important to follow the recommended dosage guidelines to avoid potential health risks. Additionally, you should not use the maximum dosage of this product for more than 2 weeks unless your doctor has advised you to do so.

If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical help. Always prioritize your health and consult a healthcare professional if you have any concerns about your medication use.

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 giving them this medication. For adults and children aged 12 years and older, the recommended dosage is to fully chew and then swallow 1 or 2 chewable tablets when symptoms occur, or as directed by a healthcare professional. Always follow your doctor's advice to ensure safe and effective use.

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 before starting the medication. 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 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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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, 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 room temperature. It's important to keep it away from excessive heat, so make sure it does not exceed 40°C (104°F). This will help maintain its effectiveness and safety for use.

When handling the product, always do so with clean hands and in a clean environment to prevent contamination. If you have any specific disposal instructions, be sure to follow them carefully to ensure safe and responsible disposal.

Additional Information

You should take this medication orally. Before using it, consult with your doctor or pharmacist, especially if you are currently taking any prescription drugs, as antacids can interact with some medications. If you are pregnant or breastfeeding, it's important to seek advice from a healthcare professional before use.

FAQ

What symptoms does this drug relieve?

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

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over should fully chew and then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor.

What should children under 12 do before using this drug?

Children under 12 years should consult a doctor before use.

Is there a limit to how many chewable tablets I can take in a day?

You should not take more than 5 chewable tablets in a 24-hour period.

Are there any warnings associated with this drug?

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

What should I do if I am pregnant or breastfeeding?

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

Can this drug interact with other medications?

Yes, antacids may interact with certain prescription drugs, so consult a doctor or pharmacist if you are taking other medications.

How should I store this drug?

Store at room temperature and avoid excessive heat above 40°C (104°F).

Packaging Info

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

Packaging configurations for Legend Premium Heartburn Chewable.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the relief of acid indigestion, heartburn, sour stomach, and upset stomach associated with these symptoms. Additionally, it 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 fully chew and then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a healthcare professional. For children under 12 years of age, consultation with a doctor is recommended prior to administration.

It is important to note that the maximum dosage should not exceed 5 chewable tablets within a 24-hour period.

Contraindications

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

Warnings and Precautions

Patients with a history of allergic reactions to this product or any of its ingredients should not use it. Prior to administration, it is essential for individuals currently taking prescription medications to consult with a healthcare provider or pharmacist, as antacids may interact with certain drugs.

When utilizing this product, it is critical to adhere to the following guidelines: the maximum dosage should not exceed 5 chewable tablets within a 24-hour period. Furthermore, the maximum dosage should not be maintained for longer than 2 weeks unless directed and monitored by a physician. Users should be aware that constipation may occur as a side effect.

For individuals who are pregnant or breastfeeding, it is advisable to seek guidance from a healthcare professional before use to ensure safety for both the mother and child.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious allergic reactions may occur; therefore, individuals with a history of allergic reactions to this product or any of its ingredients should not use it.

Commonly reported adverse reactions include constipation, which may affect some patients. It is advisable for patients to consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs.

Patients are cautioned not to exceed a maximum dosage of 5 chewable tablets within a 24-hour period. Additionally, the maximum dosage should not be used for more than 2 weeks unless under the guidance and supervision of a physician. Pregnant or breastfeeding individuals should seek advice from a health professional before using 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 outcomes. Healthcare professionals should consider this timing when prescribing medications that may be affected by antacids.

Packaging & NDC

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

Packaging configurations for Legend Premium Heartburn Chewable.
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 fully chew and then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a healthcare provider.

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

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 the safety of both the mother and the developing fetus.

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 have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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. Exceeding this limit may lead to potential health risks.

Additionally, the maximum dosage of this product should not be utilized for more than two weeks unless specifically directed and monitored by a physician. Prolonged use at maximum dosage without medical supervision may increase the likelihood of serious side effects.

Healthcare professionals are advised to monitor patients for any symptoms of overdosage and to provide appropriate management based on the clinical presentation. If an overdosage is suspected, immediate medical attention should be sought to ensure patient safety and to implement necessary interventions.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. Constipation may occur as a non-teratogenic effect. No relevant information is available regarding carcinogenicity, mutagenicity, or impairment of fertility in the nonclinical studies conducted. Additionally, there is no pertinent data related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified reports of constipation associated with the use of this product. These events were reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that the storage environment does not exceed temperatures of 40°C (104°F). Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs. Additionally, patients who are pregnant or breastfeeding should seek guidance from a healthcare professional before using this medication.

Drug Information (PDF)

This file contains official product information for Legend Premium Heartburn Chewable, 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 Legend Premium Heartburn Chewable, 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.