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Fw Extra Strength Af Smooth Antacid

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Active ingredient
Calcium Carbonate 750 mg
Other brand names
Drug classes
Blood Coagulation Factor, Phosphate Binder
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 2024
Label revision date
April 16, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 750 mg
Other brand names
Drug classes
Blood Coagulation Factor, Phosphate Binder
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 2024
Label revision date
April 16, 2024
Manufacturer
Family Dollar Services, Inc.
Registration number
part331
NDC root
55319-925
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

Calcium carbonate is an extra strength antacid that comes in chewable tablet form, available in assorted fruit flavors. It is designed to help relieve symptoms of acid indigestion and heartburn, providing you with quick relief when you need it most.

This medication works by neutralizing stomach acid, which can help alleviate discomfort associated with these common digestive issues. Each bottle contains 60 chewable tablets, making it a convenient option for managing occasional heartburn and indigestion.

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.

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 medication responsibly to ensure your safety. You should not take more than 10 tablets within a 24-hour period, and you should avoid using the maximum dosage for more than 2 weeks unless your doctor advises you to do so. Following these guidelines helps prevent potential risks associated with misuse or overuse. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

You may experience some side effects when taking this medication. While no specific side effects are listed, it's important to be aware that antacids can interact with certain prescription drugs, which may affect how well those medications work. If you have any concerns or notice unusual symptoms, be sure to consult your healthcare provider for guidance.

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 you should not use the maximum dosage for more than 2 weeks unless your doctor advises you to do so.

If you experience any unusual symptoms or have concerns about your health while using this product, it's best to consult your doctor for guidance. Always prioritize your well-being and seek professional advice when needed.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, 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. Remember, timely intervention can make a significant difference.

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

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

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 problems, it's important to know that your medication dosage may need to be adjusted. Your healthcare provider will monitor your renal function tests, which help assess how well your kidneys are working. If your creatinine clearance (a measure of kidney function) falls below a certain level, a reduced dose of your medication may be necessary. Additionally, if you have severe renal impairment, special monitoring will be advised to ensure your safety and the effectiveness of your treatment. Always discuss any concerns with your healthcare provider to ensure the best care for your condition.

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 for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment 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 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 the container tightly closed when not in use to protect the contents from contamination and maintain their effectiveness. By following these simple storage guidelines, you can help ensure the product remains safe and ready for use whenever you need it.

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 using this medication.

FAQ

What is Calcium Carbonate used for?

Calcium Carbonate is used to relieve acid indigestion and heartburn.

How should I take Calcium Carbonate?

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 restrictions for Calcium Carbonate?

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.

Can I use Calcium Carbonate if I am pregnant or breastfeeding?

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

Are there any known side effects of Calcium Carbonate?

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

How should I store Calcium Carbonate?

Store at room temperature and keep the container tightly closed.

What should I do if I have kidney problems?

Renal impairment may require dosage adjustments, and it's advised to monitor renal function tests in patients with kidney issues.

Is there any contraindication for using Calcium Carbonate?

No specific contraindications are mentioned.

Packaging Info

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

Packaging configurations for Fw Extra Strength Af Smooth Antacid.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product belongs to the Wellness™ family and is formulated as an extra strength antacid in the form of chewable tablets. Each tablet contains 750 mg of calcium carbonate, which is comparable to the active ingredient in TUMS® Smoothies E-X*. The tablets are designed to dissolve smoothly and are available in assorted fruit flavors. The product is packaged with a National Drug Code (NDC) of 55319-925-23 and contains a total of 60 chewable tablets per container.

Uses and Indications

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

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

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 utilize the maximum dosage for more than 2 weeks without the advice and supervision of a healthcare professional. This limitation is essential to prevent potential adverse effects associated with prolonged or excessive use.

Warnings and Precautions

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

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 under the guidance and supervision of a qualified healthcare provider. This precaution is essential to prevent potential adverse effects associated with prolonged use or overdose.

Currently, there are no specific laboratory tests recommended for monitoring the safe use of this product. However, healthcare professionals should remain vigilant and assess the patient's overall health and response to treatment during the course of therapy.

In the absence of specific emergency medical help instructions or directives to discontinue use and consult a physician, it is advisable for healthcare providers to maintain open communication with patients regarding any unusual symptoms or concerns that may arise during treatment.

Side Effects

Patients may experience various adverse reactions associated with the use of this medication. While no specific side effects are detailed in the warnings section, it is important to note that antacids may interact with certain prescription drugs, potentially leading to altered efficacy or increased side effects of those medications.

In clinical practice, healthcare providers should be vigilant in monitoring patients for any unexpected reactions, particularly in those who are concurrently using antacids with other prescribed therapies. It is advisable for patients to inform their healthcare providers of all medications they are taking to mitigate the risk of adverse interactions.

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 treatment.

Packaging & NDC

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

Packaging configurations for Fw Extra Strength Af 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

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 considered, as the effects on fetal outcomes and breastfeeding infants are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in these patients to assess their kidney status. For patients with a creatinine clearance below a specified threshold, a reduced dose should be considered to mitigate the risk of adverse effects. Additionally, special monitoring is advised for patients with severe renal impairment to ensure appropriate management of their treatment.

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 consider general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

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 use 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. 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 the medication.

Drug Information (PDF)

This file contains official product information for Fw Extra Strength Af 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 Fw Extra Strength Af 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.