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Legend Premium Heartburn Chewable Relief

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Calcium Carbonate 500 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 ingredient
Calcium Carbonate 500 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
13411-845
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 acid indigestion, heartburn, sour stomach, or an upset stomach. This medication is designed to provide relief from these common digestive issues. It works by addressing the underlying causes of these symptoms, helping to soothe your stomach and restore comfort. If you're looking for a way to alleviate these uncomfortable feelings, this medication could be a helpful option for you.

Uses

If you're experiencing discomfort from acid indigestion, heartburn, or a sour stomach, this medication can help provide relief. It is also effective for soothing an upset stomach that comes along with these symptoms.

You can feel confident using this medication, as there are no known teratogenic effects (which means it doesn't cause birth defects) associated with it. This makes it a safe option for many individuals seeking relief from these common digestive issues.

Dosage and Administration

When you need relief from your symptoms, adults and children aged 12 years and older can take 2 to 3 chewable tablets. Make sure to fully chew the tablets before swallowing them. You can take these tablets as symptoms occur or follow your doctor's advice on when to take them. However, it's important not to exceed 5 chewable tablets in a 24-hour period to ensure your safety.

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

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance).

Since there are no explicit "do not take" or "do not use" instructions, it is important to consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you. Always prioritize open communication with your doctor about any concerns or questions you may have regarding 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. Some people may experience constipation while using it. It's important to consult with a doctor or pharmacist 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 not use this product if you have ever had an allergic reaction to it or any of its ingredients. Before using it, consult with your doctor or pharmacist, especially if you are currently taking any prescription medications, as antacids can interact with certain drugs.

While using this product, remember to limit yourself to a maximum of 5 chewable tablets in a 24-hour period. Avoid using the highest dosage for more than 2 weeks unless your doctor advises you to do so. Be aware that constipation may occur as a side effect. If you are pregnant or breastfeeding, it’s important to speak with a healthcare professional before using this product.

If you experience any severe reactions or symptoms, seek emergency help immediately. Additionally, stop using the product and call your doctor if you have any concerns or unusual side effects.

Overdose

Taking more than 5 chewable tablets in a 24-hour period can lead to an overdose. It's important to avoid using the maximum dosage of this product for more than 2 weeks unless your doctor has advised you to do so. If you experience symptoms like constipation, it may be a sign of an overdose.

If you suspect an overdose, seek immediate medical help. It's always better to be cautious, so if you have any concerns about your dosage or experience unusual symptoms, contact your healthcare provider right away.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you have a child 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 2 to 3 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

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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

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.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

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 your other medications could affect how well those medications work.

To ensure your treatment is safe and effective, 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.

When handling the product, always do so with clean hands and in a clean environment to avoid 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. If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using this medication to ensure it's safe for you and your baby.

FAQ

What symptoms does this drug relieve?

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

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

Adults and children 12 years and over should fully chew then swallow 2 to 3 chewable tablets as symptoms occur, or as directed by a doctor.

What should children under 12 do?

Children under 12 years should consult a doctor before use.

Are there any dosage limits?

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

What should I do if I am pregnant or breastfeeding?

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

What should I know about potential allergic reactions?

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

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.

What are some possible side effects?

Constipation may occur when using this product.

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 Relief (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Legend Premium Heartburn Chewable Relief.
Details

Drug Information (PDF)

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

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 2 to 3 chewable tablets as symptoms occur, or as directed by a healthcare professional. For children under 12 years of age, it is recommended to consult a doctor 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 not classified as a controlled substance, and there are no identified risks of abuse, misuse, or dependence.

Warnings and Precautions

Patients with a known allergy 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. Patients should be counseled to separate the dosing of antacids and other drugs by at least two hours when possible to ensure optimal therapeutic outcomes.

Packaging & NDC

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

Packaging configurations for Legend Premium Heartburn Chewable Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the recommended dosage is to fully chew and then swallow 2 to 3 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 safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in 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 terms of 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 data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 the event of overdosage, it is critical to adhere to the recommended dosage guidelines to mitigate potential adverse effects.

Dosage Limitations Healthcare professionals should advise patients not to exceed five chewable tablets within a 24-hour period. This limitation is essential to prevent the risk of overdosage and associated complications.

Duration of Maximum Dosage Patients are cautioned against using the maximum dosage of this product for longer than two weeks unless under the guidance and supervision of a physician. Prolonged use at maximum dosage may lead to increased risk of adverse effects.

Potential Symptoms One of the common symptoms associated with overdosage is constipation. Healthcare providers should monitor patients for this and other potential symptoms that may arise from excessive intake.

Management Procedures In cases of suspected overdosage, it is advisable to seek immediate medical attention. Management may include symptomatic treatment and supportive care as necessary. Healthcare professionals should evaluate the patient's condition and provide appropriate interventions based on the severity of symptoms.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Constipation may occur as a non-teratogenic effect. There is no additional information available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 excessive heat above 40°C (104°F). Proper handling should be observed to maintain the integrity of the product during storage.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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