Multi-Vit/fl 0.25mg Drops 50ml
It is used to help growth and good health.Fluoride may be in the vitamin to prevent tooth decay.
Drug Class
Vitamin/Mineral Supplement; Dental Caries Prophylaxis
Pharmacologic Class
Multivitamin; Fluoride Supplement
Pregnancy Category
Not applicable (pediatric product)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medicine is a liquid vitamin supplement for babies and children that also contains fluoride. Vitamins help your child grow and stay healthy, while fluoride helps make their teeth strong and prevents cavities.
How to Use This Medicine
Taking This Medication
To ensure your child takes this medication safely and effectively, follow the instructions provided by their doctor and the information included with the medication. You can give this medication to your child with or without food. If it causes stomach upset, consider giving it with food to help alleviate this issue.
It's essential to note that some medications must be taken with food, on an empty stomach, or have no specific requirements regarding food intake. Consult with your pharmacist to determine the best approach for giving this medication to your child.
When measuring liquid doses, use the measuring device provided with the medication to ensure accuracy. Before administering, shake the medication well. Some products can be mixed with formula, fruit juice, or other foods and liquids, while others should be placed directly into your child's mouth. Understand the specific instructions for administering this medication to your child.
Storing and Disposing of This Medication
Store the medication in its original container at room temperature, in a dry location, and away from bathrooms. Protect the medication from heat and light to maintain its effectiveness.
Missing a Dose
If you miss giving your child a dose, administer it as soon as you remember. However, if the missed dose is close to the time for the next scheduled dose, skip the missed dose and resume the regular dosing schedule. Do not give your child two doses at the same time or extra doses, as this can increase the risk of adverse effects.
To ensure your child takes this medication safely and effectively, follow the instructions provided by their doctor and the information included with the medication. You can give this medication to your child with or without food. If it causes stomach upset, consider giving it with food to help alleviate this issue.
It's essential to note that some medications must be taken with food, on an empty stomach, or have no specific requirements regarding food intake. Consult with your pharmacist to determine the best approach for giving this medication to your child.
When measuring liquid doses, use the measuring device provided with the medication to ensure accuracy. Before administering, shake the medication well. Some products can be mixed with formula, fruit juice, or other foods and liquids, while others should be placed directly into your child's mouth. Understand the specific instructions for administering this medication to your child.
Storing and Disposing of This Medication
Store the medication in its original container at room temperature, in a dry location, and away from bathrooms. Protect the medication from heat and light to maintain its effectiveness.
Missing a Dose
If you miss giving your child a dose, administer it as soon as you remember. However, if the missed dose is close to the time for the next scheduled dose, skip the missed dose and resume the regular dosing schedule. Do not give your child two doses at the same time or extra doses, as this can increase the risk of adverse effects.
Lifestyle & Tips
- Administer the drops directly into the child's mouth or mix with formula, juice, or food (avoid dairy products when giving fluoride).
- Do not exceed the recommended dose. More is not better and can be harmful.
- Store out of reach of children, as overdose can be dangerous.
- Continue regular dental check-ups for your child.
- Maintain good oral hygiene practices, including brushing with fluoride toothpaste (age-appropriate amount) once teeth erupt.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Not applicable (pediatric product)
Pediatric Dosing
Neonatal:
Not established (typically not recommended for infants under 6 months unless specifically indicated by a healthcare professional based on fluoride water levels and nutritional needs)
Infant:
Dosing is highly dependent on age and fluoride concentration in drinking water. For infants 6 months to 3 years, typically 0.25 mg fluoride daily if drinking water fluoride concentration is <0.3 ppm. Multivitamin component dosing varies by product, generally 1 mL daily.
Child:
Dosing is highly dependent on age and fluoride concentration in drinking water. For children 3-6 years, typically 0.5 mg fluoride daily if drinking water fluoride concentration is <0.3 ppm. For children 6-16 years, typically 1.0 mg fluoride daily if drinking water fluoride concentration is <0.3 ppm. Multivitamin component dosing varies by product, generally 1 mL daily.
Adolescent:
Dosing is highly dependent on age and fluoride concentration in drinking water. For adolescents 6-16 years, typically 1.0 mg fluoride daily if drinking water fluoride concentration is <0.3 ppm. Multivitamin component dosing varies by product, generally 1 mL daily.
Dose Adjustments
Renal Impairment:
Mild:
Caution advised for fluoride component; monitor for fluorosis. Multivitamin component generally safe.
Moderate:
Contraindicated for fluoride component due to risk of accumulation and fluorosis. Multivitamin component generally safe, but fat-soluble vitamins may accumulate.
Severe:
Contraindicated for fluoride component. Multivitamin component generally safe, but fat-soluble vitamins may accumulate.
Dialysis:
Contraindicated for fluoride component. Consult physician for multivitamin component.
Hepatic Impairment:
Mild:
No specific adjustment for multivitamin/fluoride drops.
Moderate:
No specific adjustment for multivitamin/fluoride drops.
Severe:
No specific adjustment for multivitamin/fluoride drops.
Pharmacology
Mechanism of Action
Multivitamins provide essential vitamins and minerals necessary for normal growth, development, and metabolic functions, acting as coenzymes or cofactors in various biochemical reactions. Fluoride incorporates into the enamel structure of developing teeth, making them more resistant to acid demineralization, and promotes remineralization of early carious lesions. It also has antibacterial effects against oral pathogens.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (depends on specific vitamin/mineral and formulation); Fluoride: ~90-95% absorbed from the GI tract.
Tmax:
Variable (depends on specific vitamin/mineral); Fluoride: 30-60 minutes.
FoodEffect:
Some vitamins (e.g., fat-soluble) are better absorbed with food. Fluoride absorption may be reduced by calcium, magnesium, or aluminum-containing foods/supplements.
Distribution:
Vd:
Variable; Fluoride: Distributes widely, primarily to calcified tissues (bones, teeth).
ProteinBinding:
Variable; Fluoride: Low protein binding.
CnssPenetration:
Limited for most vitamins; Fluoride: Limited, but can cross blood-brain barrier.
Elimination:
HalfLife:
Variable (hours to days); Fluoride: ~2-9 hours (plasma), much longer in calcified tissues.
Clearance:
Variable; Fluoride: Primarily renal.
ExcretionRoute:
Renal (primary for water-soluble vitamins and fluoride), biliary (for some fat-soluble vitamins).
Unchanged:
Variable; Fluoride: ~50% excreted unchanged in urine within 24 hours.
Pharmacodynamics
OnsetOfAction:
Nutritional effects are gradual; Fluoride's dental benefits are cumulative over time with consistent use.
PeakEffect:
Not acutely measurable for overall nutritional support; Fluoride's peak plasma concentration occurs within an hour, contributing to immediate enamel uptake.
DurationOfAction:
Daily supplementation provides continuous nutritional support; Fluoride's protective effects are long-lasting due to incorporation into tooth structure.
Confidence:
Medium
Safety & Warnings
Side Effects
Important Side Effects to Report Immediately
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If your child exhibits any of the following symptoms, seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in the appearance of teeth or gums
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to monitor your child's response to the medication. If your child experiences any of the following side effects or any other unusual symptoms that bother them or persist, consult their doctor:
Upset stomach or vomiting
Note: This list is not exhaustive, and your child may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your child's doctor for guidance.
Reporting Side Effects
To report side effects, you can:
Call your child's doctor for medical advice
Contact the FDA at 1-800-332-1088
Submit a report online at https://www.fda.gov/medwatch
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If your child exhibits any of the following symptoms, seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in the appearance of teeth or gums
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to monitor your child's response to the medication. If your child experiences any of the following side effects or any other unusual symptoms that bother them or persist, consult their doctor:
Upset stomach or vomiting
Note: This list is not exhaustive, and your child may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your child's doctor for guidance.
Reporting Side Effects
To report side effects, you can:
Call your child's doctor for medical advice
Contact the FDA at 1-800-332-1088
Submit a report online at https://www.fda.gov/medwatch
Seek Immediate Medical Attention If You Experience:
- White or brown spots/streaks on teeth (signs of fluorosis)
- Nausea, vomiting, stomach pain, diarrhea (especially with overdose)
- Unusual tiredness or weakness
- Changes in vision (rare, with very high Vitamin A overdose)
- Increased urination or thirst (rare, with very high Vitamin D overdose)
Before Using This Medicine
Before Giving Your Child This Medication: Inform Your Doctor If:
- Your child is allergic to this medication, any of its components, or any other medications, foods, or substances. Describe the allergy and the symptoms your child experienced.
- Your child has a history of certain health issues, including bone problems, joint problems, kidney problems, or ulcers.
- Your child's drinking water contains sufficient fluoride. If you're unsure, consult with the doctor to determine the appropriate course of action.
It's essential to note that this list is not exhaustive, and there may be other medications or health conditions that interact with this drug.
To ensure safe treatment, inform the doctor and pharmacist about all medications your child is taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems. Always verify that it's safe to administer this medication alongside your child's other medications and health conditions. Never start, stop, or adjust the dosage of any medication your child is taking without first consulting the doctor.
- Your child is allergic to this medication, any of its components, or any other medications, foods, or substances. Describe the allergy and the symptoms your child experienced.
- Your child has a history of certain health issues, including bone problems, joint problems, kidney problems, or ulcers.
- Your child's drinking water contains sufficient fluoride. If you're unsure, consult with the doctor to determine the appropriate course of action.
It's essential to note that this list is not exhaustive, and there may be other medications or health conditions that interact with this drug.
To ensure safe treatment, inform the doctor and pharmacist about all medications your child is taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems. Always verify that it's safe to administer this medication alongside your child's other medications and health conditions. Never start, stop, or adjust the dosage of any medication your child is taking without first consulting the doctor.
Precautions & Cautions
Important Information for Patients Taking This Medication
It is essential to inform all of your child's healthcare providers, including doctors, nurses, pharmacists, and dentists, that your child is taking this medication. This is crucial because different brands of this medication may be suitable for different age groups, and your child's doctor needs to be consulted before administering this medication to a child.
Administration and Dosage
Do not exceed the recommended dose or frequency of administration, as this may lead to adverse effects. If you are unsure about the correct dosage for your child, consult with their doctor. The dosage may vary depending on your child's age, so it is crucial to follow the doctor's instructions.
Lab Tests and Interactions
This medication may interfere with certain laboratory tests. Therefore, it is vital to inform all healthcare providers and laboratory personnel that your child is taking this medication.
Dental Care
Regular dental check-ups are essential to maintain your child's oral health. If your child's teeth become stained or spotted, inform their dentist. Additionally, encourage good oral hygiene practices to prevent dental problems.
Safety Precautions
In case of accidental ingestion of a large amount of this medication, seek medical attention immediately by calling a doctor or poison control center. To minimize the risk of interactions, do not give your child products containing calcium (such as dairy products) or aluminum/magnesium (such as certain antacids) within 2 hours of taking this medication.
Pregnancy and Breastfeeding
If your child is pregnant, becomes pregnant, or is breastfeeding, consult with their doctor to discuss the potential benefits and risks to both your child and the baby.
Additional Considerations
If your child is using purified water, note that it may not contain fluoride. Regular dental check-ups can help monitor your child's oral health and address any concerns related to fluoride intake.
It is essential to inform all of your child's healthcare providers, including doctors, nurses, pharmacists, and dentists, that your child is taking this medication. This is crucial because different brands of this medication may be suitable for different age groups, and your child's doctor needs to be consulted before administering this medication to a child.
Administration and Dosage
Do not exceed the recommended dose or frequency of administration, as this may lead to adverse effects. If you are unsure about the correct dosage for your child, consult with their doctor. The dosage may vary depending on your child's age, so it is crucial to follow the doctor's instructions.
Lab Tests and Interactions
This medication may interfere with certain laboratory tests. Therefore, it is vital to inform all healthcare providers and laboratory personnel that your child is taking this medication.
Dental Care
Regular dental check-ups are essential to maintain your child's oral health. If your child's teeth become stained or spotted, inform their dentist. Additionally, encourage good oral hygiene practices to prevent dental problems.
Safety Precautions
In case of accidental ingestion of a large amount of this medication, seek medical attention immediately by calling a doctor or poison control center. To minimize the risk of interactions, do not give your child products containing calcium (such as dairy products) or aluminum/magnesium (such as certain antacids) within 2 hours of taking this medication.
Pregnancy and Breastfeeding
If your child is pregnant, becomes pregnant, or is breastfeeding, consult with their doctor to discuss the potential benefits and risks to both your child and the baby.
Additional Considerations
If your child is using purified water, note that it may not contain fluoride. Regular dental check-ups can help monitor your child's oral health and address any concerns related to fluoride intake.
Overdose Information
Overdose Symptoms:
- Acute fluoride overdose: Nausea, vomiting, abdominal pain, diarrhea, salivation, headache, weakness, muscle spasms, convulsions, cardiac arrhythmias.
- Chronic fluoride overdose (fluorosis): Dental mottling (white flecks to brown stains), skeletal fluorosis (rare, with very high chronic intake).
- Vitamin overdose (hypervitaminosis): Symptoms vary by vitamin (e.g., Vitamin A: dry skin, hair loss, headache, liver damage; Vitamin D: hypercalcemia, kidney stones).
What to Do:
Immediately contact a poison control center (1-800-222-1222) or seek emergency medical attention. For acute fluoride overdose, milk or calcium-containing liquids may be given to bind fluoride. Treatment is supportive.
Drug Interactions
Major Interactions
- Antacids (calcium, magnesium, aluminum-containing): May decrease fluoride absorption.
- Dairy products/Calcium supplements: May decrease fluoride absorption.
Moderate Interactions
- Tetracyclines: Some multivitamin components (e.g., calcium, iron) can chelate tetracyclines, reducing absorption.
- Quinolone antibiotics: Some multivitamin components (e.g., calcium, iron) can chelate quinolones, reducing absorption.
- Levothyroxine: Iron and calcium can impair absorption.
- Warfarin: High doses of Vitamin K can antagonize warfarin. (Unlikely in pediatric multivitamin doses).
Monitoring
Baseline Monitoring
Fluoride concentration in drinking water
Rationale: To determine appropriate fluoride supplementation dosage and prevent fluorosis.
Timing: Prior to initiation of fluoride supplementation.
Dietary intake assessment
Rationale: To assess need for multivitamin supplementation and identify potential deficiencies.
Timing: Prior to initiation.
Routine Monitoring
Dental examinations
Frequency: Every 6-12 months
Target: Absence of dental caries, absence of fluorosis
Action Threshold: Presence of dental caries or signs of fluorosis (e.g., white flecks on teeth) may indicate need for dose adjustment or re-evaluation.
Growth and development milestones
Frequency: Regular pediatric check-ups
Target: Normal growth curves and developmental progress
Action Threshold: Failure to thrive or developmental delays may indicate underlying nutritional issues or need for further assessment.
Symptom Monitoring
- Signs of dental fluorosis (e.g., white flecks, streaks, or brown stains on teeth)
- Gastrointestinal upset (nausea, vomiting, diarrhea, abdominal pain) - especially with acute overdose
- Signs of hypervitaminosis (e.g., hypercalcemia with excess Vitamin D, pseudotumor cerebri with excess Vitamin A)
- Allergic reactions (rare)
Special Patient Groups
Pregnancy
Not applicable; this product is for pediatric use.
Trimester-Specific Risks:
First Trimester:
Not applicable
Second Trimester:
Not applicable
Third Trimester:
Not applicable
Lactation
Not applicable; this product is for pediatric use.
Infant Risk:
Not applicable
Pediatric Use
This product is specifically formulated for pediatric use. Dosing must be carefully determined based on the child's age and the fluoride concentration in their primary drinking water source to prevent dental fluorosis while ensuring adequate fluoride intake for caries prevention. Multivitamin component addresses general nutritional needs in growing children.
Geriatric Use
Not applicable; this product is for pediatric use.
Clinical Information
Clinical Pearls
- Always verify the fluoride concentration in the child's drinking water before prescribing or recommending fluoride supplements to avoid over-supplementation and fluorosis.
- Educate parents on the importance of proper dosing and storage to prevent accidental overdose, which can be serious, especially with fluoride.
- Advise parents to administer fluoride supplements separately from milk or calcium-rich foods/supplements to maximize absorption.
- This product is typically indicated for infants and children living in areas with suboptimal fluoride levels in their community water supply (<0.3 ppm).
- Regular dental check-ups are crucial to monitor for both dental caries and signs of fluorosis.
Alternative Therapies
- Dietary counseling for nutritional deficiencies
- Topical fluoride applications (varnishes, gels, foams) by a dental professional
- Fluoridated toothpaste and mouth rinses (age-appropriate)
- Community water fluoridation
Cost & Coverage
Average Cost:
$10 - $30 per 50ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often OTC, may not be covered by prescription plans)
General Drug Facts
If your child's symptoms or health issues persist or worsen, it is essential to contact their doctor promptly. To ensure safe use, never share your child's medication with others, and do not administer someone else's medication to your child. For comprehensive information about this medication, consult the patient information leaflet that may accompany it. If you have any questions or concerns, discuss them with your child's doctor, nurse, pharmacist, or other healthcare provider. Additionally, you can check with your pharmacist to see if there is a separate patient information leaflet available for this drug. In the event of a suspected overdose, immediately call the poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time of the incident.