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Legend Premium Heartburn Relief - Extra Strength Chewable

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
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 ingredient
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
13411-843
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 looking for a medication that helps relieve discomfort from common digestive issues. This drug is used to alleviate symptoms such as acid indigestion, heartburn, sour stomach, and upset stomach associated with these conditions. It works by addressing the underlying causes of these symptoms, providing you with relief when you need it most.

Uses

If you're experiencing discomfort from acid indigestion, heartburn, or a sour stomach, this medication can help provide relief. It is specifically designed to ease the symptoms associated with these conditions, including an upset stomach that may arise from them.

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 associated with it. This makes it a safe option for managing your digestive discomfort.

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

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 particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

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 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 maximum dosage for more than 2 weeks unless directed by your doctor. Be aware that constipation may occur as a side effect. If you are pregnant or breastfeeding, it’s important to seek advice from a healthcare professional before using this product.

If you experience any severe reactions or symptoms, such as difficulty breathing or swelling, seek emergency help immediately. Additionally, if you notice any unusual or concerning side effects, stop using the product and contact your doctor right away.

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 advises 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 with 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 you have a child under 12 years old, it's important to consult a doctor before giving them this medication. For children aged 12 and older, they can take 1 or 2 chewable tablets as needed for symptoms, but they should fully chew and then swallow the tablets. Always follow your doctor's guidance regarding dosage and frequency.

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 responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney issues, 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 standard recommendations for the medication do not change based on renal impairment. However, it’s always best to discuss your individual situation with your healthcare provider, as they can offer personalized advice and monitor your health closely.

Make sure to keep your doctor informed about your kidney health, as they may need to consider this when prescribing medications or adjusting dosages in the future. Regular check-ups and open communication are key to managing your health effectively.

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 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 at room temperature. It's important to keep it away from areas with high humidity, as moisture can affect its quality and effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any specific instructions provided with the product for safe use and 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 is this drug used for?

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

How should adults and children 12 years and over take this drug?

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

What should children under 12 do before taking this drug?

Children under 12 years should consult a doctor before taking this drug.

What is the maximum number of 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 I should be aware of?

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

Can I use this drug 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 am taking other prescription drugs?

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

How should I store this drug?

Store at room temperature and avoid humidity.

Packaging Info

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

Packaging configurations for Legend Premium Heartburn Relief - Extra Strength Chewable.
Details

Drug Information (PDF)

This file contains official product information for Legend Premium Heartburn Relief - Extra Strength 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.

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 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 pregnant or breastfeeding individuals, 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, it is contraindicated in individuals who have a history of allergic reactions to this product or any of its ingredients.

Commonly reported adverse reactions include constipation, which may affect some patients. Additionally, it is important for patients to consult with a healthcare professional if they are currently taking prescription medications, as antacids may interact with certain drugs.

Patients are advised not to exceed a maximum dosage of 5 chewable tablets within a 24-hour period. Furthermore, the maximum dosage should not be used for more than 2 weeks unless directed by a physician. Pregnant or breastfeeding individuals should seek advice from a healthcare professional prior to use.

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 Legend Premium Heartburn Relief - Extra Strength Chewable (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Legend Premium Heartburn Relief - Extra Strength 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.

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 human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 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 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.

Healthcare professionals should be aware that the maximum dosage of this product should not be utilized for more than two weeks unless under the guidance and supervision of a physician. Prolonged use at maximum dosage without medical oversight may increase the likelihood of serious side effects.

In cases of suspected overdosage, it is advisable to monitor the patient for any symptoms that may arise and to initiate appropriate management procedures. Immediate consultation with a medical professional is recommended to assess the situation and determine the necessary interventions.

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. No specific information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 it is kept in a dry environment to avoid humidity. Proper handling and storage conditions are crucial to maintain the integrity and efficacy 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 Relief - Extra Strength 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 Relief - Extra Strength 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.