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Nutralox

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Calcium Carbonate 420 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 1987
Label revision date
June 5, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 420 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 1987
Label revision date
June 5, 2020
Manufacturer
HART Health
Registration number
part331
NDC root
50332-0106
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

You may find this medication helpful if you experience discomfort from heartburn, sour stomach, acid indigestion, or an upset stomach. It is designed to provide temporary relief from these common digestive issues, allowing you to feel more comfortable throughout your day.

While the specific mechanism of action isn't detailed, medications like this typically work by neutralizing stomach acid or reducing its production, helping to alleviate the symptoms you may be experiencing. If you have any questions about how it works or whether it's right for you, consider discussing it with a healthcare professional.

Uses

If you're experiencing discomfort from heartburn, sour stomach, acid indigestion, or an upset stomach, this medication can help provide temporary relief. It works by addressing 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 should chew 2 tablets every 3 to 4 hours when you experience symptoms. It's important not to exceed 16 tablets in a 24-hour period unless your doctor advises otherwise. Additionally, you should not use the maximum dose for more than 2 weeks.

For children under 12 years of age, it's best to consult a doctor before giving them this medication. Remember, these tablets are meant to be taken orally, so make sure to chew them thoroughly for the best effect.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. If your symptoms persist for more than two weeks, you should stop using the medication and consult your doctor for further guidance. This will help ensure that you receive the appropriate care and support for your health needs.

Side Effects

If you experience any symptoms that last longer than two weeks while using this medication, it's important to stop using it and consult your doctor. Additionally, if you are currently taking any prescription medications, you should speak with your doctor or pharmacist before using this product, as antacids can interfere with some prescription drugs.

Warnings and Precautions

It's important to keep this medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

If your symptoms persist for more than two weeks, you should stop taking the medication and consult your doctor. Always prioritize your health and safety by following these guidelines.

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, or if you are unsure, seek medical help right away.

In case of an overdose, contacting your healthcare provider or local poison control center is crucial. They can provide guidance on what steps to take next. Always err on the side of caution—if you feel something is wrong, don’t hesitate to get help.

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 to address any concerns you may have regarding breastfeeding and medication use.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before giving them this medication. For those aged 12 and older, you can give them 2 tablets to chew every 3 to 4 hours as needed for symptoms, but make sure they do not exceed 16 tablets in a 24-hour period. It's also crucial not to use the maximum dose for more than 2 weeks.

Always keep this medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any special precautions or adjustments are needed based on individual health conditions and overall well-being. 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 your medication dosage may need to be adjusted. This is particularly true if your creatinine clearance (a measure of how well your kidneys are filtering waste) is less than 30 mL/min. In such cases, a reduced dose may be necessary to ensure your safety and the effectiveness of the treatment.

Additionally, your healthcare provider will likely monitor your renal function tests regularly. This helps to keep track of how well your kidneys are working and to make any necessary changes to your treatment plan. Always communicate openly with your doctor about your kidney health to ensure the best care.

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 interfere with some prescription medications. This means that taking antacids at the same time as your other medications might 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 use of your product, store it at room temperature and keep it away from direct light. This helps maintain its effectiveness. It's also important to keep the product out of reach of children for safety. Once you open the product, remember to discard it after use to avoid any potential risks. Following these simple guidelines will help you handle the product safely and effectively.

Additional Information

You should take this medication orally. If you are an adult or a child aged 12 years and older, chew 2 tablets every 3 to 4 hours as needed, but do not exceed 16 tablets in a 24-hour period unless directed by a doctor. It's important not to use the maximum dose for more than 2 weeks. If you are under 12 years old, consult a doctor before use.

Before taking this medication, ask your doctor or pharmacist if you are currently on any prescription drugs, as antacids can interfere with them. If your symptoms persist for more than 2 weeks, stop using the medication and consult a doctor. If you are pregnant or breastfeeding, seek advice from a health professional. Always keep this medication out of reach of children, and in case of an overdose, contact medical help or a Poison Control Center immediately at 1-800-222-1222.

FAQ

What conditions does this drug temporarily relieve?

This drug temporarily relieves heartburn, sour stomach, acid indigestion, and upset stomach.

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

Adults and children 12 years of age and over should thoroughly chew 2 tablets every 3 to 4 hours as symptoms occur, without exceeding 16 tablets in 24 hours unless directed by a doctor.

What should I do if symptoms last for more than 2 weeks?

You should stop use and ask a doctor if symptoms last for more than 2 weeks.

Is this drug safe for children under 12?

For children under 12 years of age, you should ask a doctor before use.

What precautions should I take if I am pregnant or breastfeeding?

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

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

How should I store this drug?

Store at room temperature, protect from light, and keep out of reach of children. Discard after opening.

Can this drug interfere with other medications?

Yes, antacids may interfere with certain prescription drugs, so ask a doctor or pharmacist before use if you are taking any prescription medications.

Packaging Info

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

Packaging configurations for Nutralox.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of heartburn, sour stomach, acid indigestion, and upset stomach.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed to thoroughly chew 2 tablets every 3 to 4 hours as symptoms occur. The maximum dosage should not exceed 16 tablets within a 24-hour period unless directed by a physician. Additionally, the maximum dose should not be utilized for more than 2 weeks.

For children under 12 years of age, it is recommended to consult a physician prior to administration.

The route of administration is oral, utilizing chewable tablets, which must be thoroughly chewed before swallowing.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to keep the product out of reach of children. Additionally, if symptoms persist for more than two weeks, discontinue use and consult a healthcare professional.

Warnings and Precautions

It is imperative to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Healthcare professionals should advise patients to discontinue use and consult a physician if symptoms persist for more than two weeks. This precaution is essential to ensure appropriate management of any underlying conditions that may require further evaluation.

Monitoring for adverse effects and the overall response to treatment is recommended, although specific laboratory tests are not detailed in this section. Regular follow-up may be necessary to assess the patient's progress and to make any necessary adjustments to the treatment regimen.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. In clinical trials and postmarketing experiences, certain reactions have been noted, which may require medical attention.

Serious adverse reactions have not been explicitly detailed; however, patients are advised to stop use and consult a healthcare professional if symptoms persist for more than two weeks. This precaution is essential to ensure that any underlying conditions are appropriately addressed.

Additionally, patients should seek advice from a doctor or pharmacist before using this medication if they are currently taking any prescription drugs. It is important to note that antacids may interfere with the efficacy of certain prescription medications, which could lead to unintended health consequences.

Overall, careful monitoring and communication with healthcare providers are recommended to mitigate risks associated with the use of this medication.

Drug Interactions

Antacids have the potential to interfere with the absorption and effectiveness of various prescription medications. This interaction is primarily pharmacokinetic in nature, as antacids can alter gastric pH and affect the solubility and subsequent absorption of certain drugs.

Healthcare professionals should be aware of this interaction and consider advising patients to separate the administration of antacids from other medications. Monitoring for therapeutic efficacy and potential side effects of the affected drugs may be warranted to ensure optimal treatment outcomes.

Packaging & NDC

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

Packaging configurations for Nutralox.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is to thoroughly chew 2 tablets every 3 to 4 hours as symptoms occur, with a maximum limit of 16 tablets in a 24-hour period unless otherwise directed by a physician. It is important to note that the maximum dosage should not be used for more than 2 weeks. Care should be taken to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 in these patients regularly. For individuals with a creatinine clearance of less than 30 mL/min, a reduced dose should be considered to mitigate the risk of adverse effects associated with decreased kidney function.

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 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 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 implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate treatment and follow-up care.

Nonclinical Toxicology

No teratogenic effects have been observed in nonclinical studies. Additionally, there are no reported non-teratogenic effects. The available data do not provide any details regarding nonclinical toxicology. Furthermore, there are no findings related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be informed to discontinue use and consult a doctor if their symptoms persist for more than two weeks. Additionally, it is important for healthcare providers to recommend that patients consult with a doctor or pharmacist before using the medication if they are currently taking any prescription drugs, as antacids may interfere with the effectiveness of certain medications.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature, away from direct light exposure to maintain its integrity. Additionally, it is essential to keep the product out of reach of children to ensure safety. Once opened, the product must be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older should thoroughly chew 2 tablets every 3 to 4 hours as symptoms occur, ensuring not to exceed 16 tablets in a 24-hour period unless directed by a physician. The maximum dose should not be used for more than 2 weeks. For children under 12 years of age, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to consult a doctor or pharmacist before use if they are currently taking prescription medications, as antacids may interfere with these drugs. Patients are also advised to discontinue use and seek medical advice if symptoms persist for more than 2 weeks. Pregnant or breastfeeding individuals should consult a health professional before use. Additionally, the medication should be kept out of reach of children, and in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is recommended.

Drug Information (PDF)

This file contains official product information for Nutralox, 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 Nutralox, 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.