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Signature Care Extra Strength Smooth Antacid

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This product has been discontinued

Active ingredient
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 2017
Label revision date
January 13, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
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 2017
Label revision date
January 13, 2022
Manufacturer
Safeway
Registration number
part331
NDC root
21130-136
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

Extra Strength Smooth Antacid Relief Tablets are chewable tablets designed to provide relief from acid indigestion and heartburn. Each tablet contains 750 mg of calcium carbonate, which is a common ingredient that helps neutralize stomach acid, offering you quick comfort from these uncomfortable symptoms.

These tablets come in a delicious berry fusion flavor and are rich in calcium, making them not only effective but also enjoyable to take. With a package containing 60 tablets, they are a convenient option for managing occasional digestive discomfort.

Uses

If you're experiencing discomfort from acid indigestion or heartburn, this medication can help relieve those symptoms. Acid indigestion is often characterized by a burning sensation in your stomach or chest, while heartburn is the feeling of warmth or pain that can rise from your stomach to your throat.

You can use this medication to find relief from these common digestive issues, allowing you to feel more comfortable throughout your day. Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those who may be concerned about such risks.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take this medication by chewing 2 to 4 tablets whenever you experience symptoms, or as your doctor advises. It's important to follow the recommended dosage to ensure the medication works effectively for you. Always consult with your healthcare provider if you have any questions about how to use this medication properly.

What to Avoid

It's important to use this product safely to avoid potential risks. You should not take more than 10 tablets within a 24-hour period. Additionally, do not use the maximum dosage for more than 2 weeks unless your doctor has advised and is supervising you. Following these guidelines will help ensure your safety and well-being while using this medication.

Side Effects

You may not experience specific side effects from this medication, but it's important to be aware that antacids can interact with certain prescription drugs. This means that if you are taking other medications, you should consult your healthcare provider to ensure there are no potential interactions that could affect your treatment. Always keep your doctor informed about all the medications you are using to help avoid any complications.

Warnings and Precautions

It's important to use this medication safely. You should not take more than 10 tablets in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks unless your doctor advises you to do so.

Before you start using this product, consult with your doctor or pharmacist if you are currently taking any prescription medications, as antacids can interact with some of them. If you experience any unusual symptoms or have concerns, it's best to stop taking the medication and reach out to your healthcare provider for guidance.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific signs or symptoms of overdose mentioned, you should be aware that common signs can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or feel something is wrong, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

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 this medication. They can provide guidance on any potential risks or effects on your milk production and your nursing infant. Always prioritize your health and your baby's well-being by seeking expert advice.

Pediatric Use

When it comes to using this medication for children, it's important to note that it is intended for adults and children aged 12 years and older. If your child is within this age range, they can chew 2 to 4 tablets as needed for their symptoms, or follow the guidance of a doctor.

Always remember to keep this medication out of reach of younger children to ensure their safety. If you have any concerns or questions about its use, don't hesitate to consult with a healthcare professional.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication with your doctor to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Regular monitoring of your kidney function tests is essential to ensure your safety and the effectiveness of your treatment. If your creatinine clearance (a measure of how well your kidneys filter waste) falls below a certain level, your doctor may recommend a reduced dose of your medication. Additionally, if you have severe renal impairment, special monitoring will be necessary to manage your health effectively. Always discuss any concerns with your healthcare provider to ensure you receive the best care tailored to your needs.

Hepatic Impairment

If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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 the container tightly closed to protect its contents from contamination and maintain its effectiveness. By following these simple storage guidelines, you can help ensure that the product remains safe and ready for use when you need it.

Additional Information

You can take this medication orally by chewing 2 to 4 tablets when symptoms occur, or as directed by your doctor, if you are an adult or a child aged 12 years and older. There is no additional information available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Extra Strength Smooth Antacid Relief Tablets used for?

It is used to relieve acid indigestion and heartburn.

What is the active ingredient in Extra Strength Smooth Antacid Relief Tablets?

The active ingredient is calcium carbonate, with each tablet containing 750 mg.

How should I take Extra Strength Smooth Antacid Relief Tablets?

Adults and children 12 years of age and over should chew 2-4 tablets as symptoms occur, or as directed by a doctor.

Are there any dosage limitations for this product?

Do not take more than 10 tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks without a doctor's advice.

Are there any side effects associated with Extra Strength Smooth Antacid Relief Tablets?

No specific side effects are listed, but antacids may interact with certain prescription drugs.

Is it safe to use Extra Strength Smooth Antacid Relief Tablets during pregnancy or breastfeeding?

You should ask a health professional before use if you are pregnant or breastfeeding.

How should I store Extra Strength Smooth Antacid Relief Tablets?

Store at room temperature and keep the container tightly closed.

What should I do if I have renal impairment?

Patients with renal impairment may require dosage adjustments and should monitor renal function tests regularly.

Is there any information regarding contraindications for this product?

No specific contraindications are mentioned.

What flavor do Extra Strength Smooth Antacid Relief Tablets come in?

They come in a berry fusion flavor.

Packaging Info

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

Packaging configurations for Signature Care Extra Strength Smooth Antacid.
Details

Drug Information (PDF)

This file contains official product information for Signature Care Extra Strength Smooth Antacid, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

This product is an extra strength chewable antacid formulation containing 750 mg of calcium carbonate as the active ingredient, designed to provide relief from acid indigestion and heartburn. The tablets are available in a berry fusion flavor and are rich in calcium. Each bottle contains 60 tablets. The product is identified by NDC 21130-136-23 and is marketed under the Signature Care brand, comparable to Tums® Smoothies™ E-X.

Uses and Indications

This drug is indicated for the relief of acid indigestion and heartburn.

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

Dosage and Administration

Adults and children 12 years of age and over are advised to chew 2 to 4 tablets as symptoms occur, or as directed by a healthcare professional. It is important to follow the recommended dosage and not exceed the maximum dosage unless specifically instructed by a physician.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage of 10 tablets within a 24-hour period or who utilize the maximum dosage for more than 2 weeks without the guidance and supervision of a healthcare professional. Adherence to these guidelines is essential to prevent potential adverse effects associated with prolonged or excessive use.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

General precautions must be observed to ensure safe usage. It is imperative that patients do not exceed a maximum dosage of 10 tablets within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than 2 weeks unless directed and supervised by a healthcare provider. This limitation is crucial to prevent potential adverse effects associated with prolonged use.

Before recommending this product, healthcare professionals should advise patients to consult with a doctor or pharmacist if they are currently taking any prescription medications. This is particularly important as antacids may interact with certain prescription drugs, which could lead to diminished efficacy or increased risk of side effects.

Monitoring for any adverse reactions or interactions is advised, although no specific laboratory tests are required for the safe use of this product.

Side Effects

Patients should be aware that no specific side effects have been listed for this medication. However, it is important to note that antacids may interact with certain prescription drugs, which could lead to altered efficacy or increased risk of adverse reactions associated with those medications.

Healthcare providers should monitor patients for any potential interactions and advise them accordingly. As with any treatment, patients are encouraged to report any unexpected symptoms or concerns to their healthcare provider.

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 Signature Care Extra Strength Smooth Antacid (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Signature Care Extra Strength Smooth Antacid.
Details

Pediatric Use

Pediatric patients aged 12 years and older may chew 2-4 tablets as symptoms occur, or as directed by a healthcare professional. It is important to keep this medication out of reach of children to ensure safety.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, 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 safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication 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 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 require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests regularly in patients with compromised kidney function. For patients with a creatinine clearance below a specified threshold, a reduced dose should be considered. Additionally, special monitoring is necessary for patients with severe renal impairment to mitigate potential risks associated with their condition.

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 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 patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may involve the following steps:

  1. Assessment: Conduct a thorough evaluation of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide symptomatic treatment as necessary, which may include intravenous fluids, oxygen supplementation, or medications to stabilize the patient's condition.

  3. Decontamination: If the overdose is recent and the patient is alert, activated charcoal may be administered to limit further absorption of the substance.

  4. Consultation: Engage with a poison control center or toxicology specialist for guidance on specific antidotes or advanced treatment options, if applicable.

Healthcare professionals should remain vigilant and prepared to implement these management strategies in the event of an overdose, despite the lack of specific information regarding the substance in question.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, there are no details provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients not to exceed a maximum of 10 tablets within a 24-hour period. Additionally, patients should be informed that the maximum dosage of this product should not be used for more than 2 weeks unless directed by a healthcare professional.

It is also important for healthcare providers to encourage patients to consult with a doctor or pharmacist prior to using this product if they are currently taking any prescription medications. Patients should be made aware that antacids may interact with certain prescription drugs, and this interaction could affect the efficacy of their treatment.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature to ensure optimal stability and efficacy.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is to chew 2-4 tablets as symptoms occur or as directed by a healthcare professional. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Signature Care Extra Strength Smooth Antacid, 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 Signature Care Extra Strength Smooth Antacid, 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.