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T-Series

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.22
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
October 18, 2019
Active ingredient
Sodium Fluoride 0.22
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2019
Label revision date
October 18, 2019
Manufacturer
SUNGWON PHARMACEUTICAL CO. , LTD.
Registration number
part355
NDC root
76058-001

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 with oral hygiene. This drug is typically used to support your dental care routine, and it is recommended that you chew 1 or 2 tablets up to three times a day. After chewing, it's important to brush your teeth gently, as if you were massaging them, to ensure effective cleaning and care for your teeth and gums.

While specific details about how this medication works are not provided, it is designed to enhance your oral health. Following the recommended usage can help you maintain a cleaner mouth and contribute to overall dental well-being.

Uses

It seems that there are no specific uses or indications provided for this medication. Without detailed information on what the drug is intended for, it's difficult to explain how it may benefit you. If you have any questions or need further clarification about this medication, it's best to consult with your healthcare provider for personalized advice. They can provide you with the necessary information based on your health needs.

Dosage and Administration

You should take this medication by mouth only. Make sure to follow the instructions provided by your healthcare provider regarding the dosage and frequency of use. It's important to take it as directed to ensure the best results for your health. If you have any questions about how to take it, don't hesitate to ask your doctor or pharmacist for clarification.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known reasons that would prevent you from taking this medication safely. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your treatment.

Side Effects

When using this toothpaste, it's important to remember that it is for oral use only and contains 1,000 ppm of fluoride. Be cautious not to swallow the toothpaste, and keep it out of reach of children. If you or someone else accidentally swallows it, seek medical help or contact a poison control center right away.

Warnings and Precautions

This toothpaste is intended for oral use only and contains 1,000 ppm fluoride, which helps protect your teeth. It's important to use it only for brushing your teeth and to avoid swallowing any of it. Please keep the toothpaste out of reach of children to ensure their safety.

If you accidentally swallow the toothpaste, seek medical help or contact a poison control center right away. Always prioritize safety and be cautious when using this product.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help right away. You can do this by contacting a poison control center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help immediately. Remember, it’s always better to be safe and get checked out if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or special precautions have not been clearly outlined.

Before taking any medication, including this one, you should consult with your healthcare provider to discuss potential risks and benefits. They can help you make informed decisions that prioritize your health and the health of your baby.

Lactation Use

If you are breastfeeding, it's important to know that some substances can be passed into your breast milk. This means that using certain products while nursing may pose a risk to your infant. Always consult with your healthcare provider about any medications or treatments you are considering to ensure they are safe for you and your baby. Being informed can help you make the best choices for your breastfeeding journey.

Pediatric Use

It's important to keep this toothpaste out of reach of children to prevent accidental swallowing. If your child does swallow it, seek medical help or contact a poison control center right away. This toothpaste contains fluoride (a mineral that helps prevent cavities) at a concentration of 1,000 parts per million (ppm), which is effective for dental health but can be harmful if ingested in large amounts. Always supervise your child while using it to ensure they use it safely.

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.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, and there are no special monitoring or precautions outlined for patients with 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 provide personalized advice and ensure that your treatment is safe and effective for you.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you start. They can help you understand how to manage your health safely and effectively.

Storage and Handling

It’s important to keep this product out of reach of children to ensure their safety. Remember, this product is intended for oral use only, so please do not use it in any other way. Once you open the product, be sure to discard it after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and responsibly.

Additional Information

You should use this toothpaste only for brushing your teeth, as it contains 1,000 ppm (parts per million) of fluoride, which helps protect against cavities. Chew 1 or 2 tablets up to three times a day, and remember to brush your teeth afterward. Be careful not to swallow the toothpaste; if you do, seek medical help or contact a poison control center right away.

FAQ

How should I use this product?

You should chew 1 or 2 tablets sufficiently within 3 times a day and then brush your teeth, either by brushing or scrubbing softly as if doing a massage.

What precautions should I take when using this product?

This product is for oral use only and has a 1,000 ppm fluoride content. Be careful not to swallow it and keep it out of reach of children.

What should I do if I swallow this product?

If swallowed, you should get medical help or contact a poison control center immediately.

Is there any information regarding the use of this product during pregnancy?

No specific information regarding the use of this product during pregnancy is provided.

Can nursing mothers use this product?

Nursing mothers should be aware of the potential for excretion in breast milk and the associated infant risk.

Are there any contraindications for this product?

No contraindications are listed for this product.

What should I do if I have concerns about using this product?

If you have any concerns, consult your healthcare provider for advice.

Packaging Info

Below are the non-prescription pack sizes of T-Series (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for T-Series.
Details

Drug Information (PDF)

This file contains official product information for T-Series, 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 additional specific description details are provided.

Uses and Indications

This drug is indicated for use in specific medical conditions as determined by healthcare professionals. Currently, there are no detailed indications or usage guidelines provided. There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare providers should evaluate the appropriateness of this drug based on individual patient needs and clinical judgment.

Dosage and Administration

The medication is intended for oral administration only. Healthcare professionals should ensure that patients are informed to take the medication by mouth, adhering strictly to the prescribed dosage regimen. It is essential to follow the specific dosing instructions provided by the prescribing physician to ensure optimal therapeutic outcomes.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

Oral use only is strictly advised for this toothpaste, which contains a fluoride concentration of 1,000 ppm. It is imperative that this product is utilized solely for the purpose of brushing teeth, and care must be taken to avoid swallowing.

This product should be stored out of reach of children to prevent accidental ingestion. In the event of swallowing the toothpaste, immediate medical assistance should be sought, or a poison control center should be contacted without delay.

No specific laboratory tests are recommended for monitoring the use of this toothpaste. However, the emphasis on keeping the product away from children remains a critical precaution to ensure safety.

Side Effects

Patients should be aware that this product is intended for oral use only. It contains a fluoride content of 1,000 ppm, which necessitates caution during use. The toothpaste is specifically designed for brushing teeth and should not be ingested. Care should be taken to avoid swallowing the product.

In the event of accidental ingestion, it is crucial to seek medical assistance or contact a poison control center immediately. Additionally, this product should be kept out of reach of children to prevent any potential misuse or accidental swallowing.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of T-Series (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for T-Series.
Details

Pediatric Use

Pediatric patients should be advised to keep this toothpaste out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a poison control center is recommended. The toothpaste contains 1,000 ppm fluoride, which is an important consideration for pediatric use.

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

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in the absence of established safety profiles. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

Nursing mothers should be aware of the potential for excretion of this product in breast milk. There is an associated risk to breastfed infants when this product is used during lactation. Healthcare professionals should consider these factors when advising lactating mothers on the use of this product.

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 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 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 warranted based on clinical judgment.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a poison control center without delay if the substance has been ingested.

Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential. Prompt recognition of symptoms can facilitate timely intervention and management.

Management of overdosage typically involves supportive care and symptomatic treatment. Healthcare providers should monitor the patient closely and implement appropriate measures based on the clinical presentation. It is crucial to follow established protocols for the specific substance involved to ensure optimal patient outcomes.

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 use of the compound in these contexts.

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 for patients to understand the potential risks associated with improper access to the medication by young individuals. Providers should emphasize the necessity of storing the medication in a secure location, away from children's sight and reach, to ensure safety.

Storage and Handling

This product is supplied in a configuration that ensures safety and efficacy for oral use only. It is essential to keep the product out of reach of children to prevent accidental ingestion. Once opened, the product must be discarded to maintain safety and integrity.

Storage conditions should be adhered to strictly, although specific temperature ranges and container requirements are not provided. Proper handling is crucial to ensure the product remains effective and safe for use.

Additional Clinical Information

The product is administered orally, with a recommended frequency of up to three times a day. Patients should chew 1 or 2 tablets thoroughly before brushing their teeth. It is important to note that this toothpaste contains 1,000 ppm fluoride and is intended for oral use only. Clinicians should advise patients to avoid swallowing the product and to seek medical assistance or contact a poison control center immediately if ingestion occurs.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for T-Series, 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 T-Series, 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.