Vit A/c/d/fl 0.5mg 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 for intended use (pediatric); components vary (e.g., Fluoride is C, Vitamins A, C, D generally safe at recommended doses).
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medicine is a special liquid vitamin supplement for babies and children. It provides important vitamins (A, C, D) needed for healthy growth, strong bones, and a good immune system. It also contains fluoride, which helps make teeth strong and prevents cavities.
How to Use This Medicine
Taking This Medication
To ensure your child takes this medication correctly, follow the instructions provided by their doctor and read all accompanying information carefully. Take this medication with or without food, but if it causes stomach upset, give it with food. However, some medications must be taken with food or on an empty stomach, so consult with your pharmacist to determine the best approach for this specific drug.
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 in your child's mouth. It's essential to understand the correct administration method for this medication, so be sure to clarify any doubts with your pharmacist.
Storing and Disposing of This Medication
Store this medication in its original container at room temperature, in a dry location, and away from heat and light. Avoid storing it in a bathroom. By following these storage instructions, you can help maintain the medication's effectiveness.
Missing a Dose
If you miss a dose, administer it as soon as you remember. However, if it's 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 correctly, follow the instructions provided by their doctor and read all accompanying information carefully. Take this medication with or without food, but if it causes stomach upset, give it with food. However, some medications must be taken with food or on an empty stomach, so consult with your pharmacist to determine the best approach for this specific drug.
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 in your child's mouth. It's essential to understand the correct administration method for this medication, so be sure to clarify any doubts with your pharmacist.
Storing and Disposing of This Medication
Store this medication in its original container at room temperature, in a dry location, and away from heat and light. Avoid storing it in a bathroom. By following these storage instructions, you can help maintain the medication's effectiveness.
Missing a Dose
If you miss a dose, administer it as soon as you remember. However, if it's 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
- Always check the fluoride level in your child's drinking water with your dentist or local water authority before starting this supplement.
- Give the exact dose prescribed by your doctor or dentist, using the dropper provided. Do not exceed the recommended dose.
- Store the drops at room temperature, away from light and moisture, and out of reach of children.
- Continue to encourage a balanced diet rich in fruits, vegetables, and other healthy foods.
- Maintain good oral hygiene practices, including brushing teeth twice daily with fluoride toothpaste (age-appropriate amount) once teeth erupt.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not indicated for adult use.
Pediatric Dosing
Neonatal:
Not established; generally not recommended for infants under 6 months unless specifically indicated by a physician and water fluoride levels are known.
Infant:
Dosing is highly dependent on the specific product formulation (concentration of vitamins and fluoride per drop/mL) and the fluoride concentration in the local drinking water. For fluoride, typical recommendations are 0.25 mg/day for infants 6 months to 3 years if drinking water contains less than 0.3 ppm fluoride. Vitamin doses are based on Recommended Dietary Allowances (RDAs) for age.
Child:
Dosing is highly dependent on the specific product formulation and the fluoride concentration in the local drinking water. For fluoride, typical recommendations are 0.5 mg/day for children 3-6 years if water fluoride is less than 0.3 ppm, or 0.25 mg/day if water fluoride is 0.3-0.6 ppm. For children 6-16 years, 1 mg/day if water fluoride is less than 0.3 ppm, or 0.5 mg/day if water fluoride is 0.3-0.6 ppm. Vitamin doses are based on RDAs for age.
Adolescent:
Dosing is highly dependent on the specific product formulation and the fluoride concentration in the local drinking water. For fluoride, typical recommendations are 1 mg/day if water fluoride is less than 0.3 ppm, or 0.5 mg/day if water fluoride is 0.3-0.6 ppm. Vitamin doses are based on RDAs for age.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution. Fluoride excretion is primarily renal. Accumulation may occur.
Moderate:
Contraindicated due to risk of fluoride accumulation and toxicity (e.g., skeletal fluorosis).
Severe:
Contraindicated due to risk of fluoride accumulation and toxicity.
Dialysis:
Contraindicated.
Hepatic Impairment:
Mild:
Generally no specific adjustment needed for vitamins at recommended doses. Fluoride is not significantly metabolized by the liver.
Moderate:
Generally no specific adjustment needed.
Severe:
Generally no specific adjustment needed.
Pharmacology
Mechanism of Action
This product provides essential vitamins (A, C, D) and fluoride. Vitamin A is crucial for vision, immune function, and cellular growth. Vitamin C is an antioxidant vital for collagen synthesis, wound healing, and immune function. Vitamin D is essential for calcium and phosphate absorption, bone mineralization, and immune system modulation. Fluoride primarily acts by incorporating into the enamel structure of developing teeth, making them more resistant to acid demineralization, promoting remineralization of early carious lesions, and inhibiting bacterial acid production in dental plaque.
Pharmacokinetics
Absorption:
Bioavailability:
Varies by vitamin (e.g., fat-soluble vitamins A and D require dietary fat for optimal absorption, water-soluble vitamin C is readily absorbed). Fluoride is rapidly and almost completely absorbed from the gastrointestinal tract (up to 90%) in the absence of interfering substances.
Tmax:
Varies by vitamin (e.g., Vitamin C: 2-3 hours; Fluoride: 30-60 minutes).
FoodEffect:
Fat-soluble vitamins (A, D) are better absorbed with food containing fat. Fluoride absorption can be reduced by calcium, magnesium, and aluminum-containing foods or antacids.
Distribution:
Vd:
Varies by vitamin. Fluoride distributes throughout the body, with approximately 50% rapidly taken up by calcified tissues (bones and teeth) and the remainder excreted.
ProteinBinding:
Varies by vitamin. Fluoride is minimally protein bound.
CnssPenetration:
Limited for vitamins at normal doses. Fluoride can cross the blood-brain barrier to a limited extent.
Elimination:
HalfLife:
Varies significantly (e.g., Vitamin C: 2-3 hours; Vitamin D: 15-30 days; Fluoride: 2-9 hours, but longer in bone).
Clearance:
Varies.
ExcretionRoute:
Vitamins: primarily renal (water-soluble), biliary/fecal (fat-soluble). Fluoride: primarily renal (50-60% within 24 hours), with significant uptake into bone.
Unchanged:
Varies for vitamins. Fluoride is excreted largely unchanged.
Pharmacodynamics
OnsetOfAction:
Nutritional effects are gradual and cumulative. Fluoride's protective effects on teeth begin with exposure during tooth development and continue with topical exposure.
PeakEffect:
Long-term, cumulative effects for nutritional benefits and dental caries prevention.
DurationOfAction:
Long-term, cumulative effects.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If your child experiences any of the following symptoms, contact their doctor immediately or seek emergency medical attention. Although rare, some people may have severe and potentially life-threatening side effects when taking this medication. Watch for signs of an allergic reaction, including:
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
Additionally, notify your child's doctor if you notice any changes in the appearance of their teeth or gums.
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If your child experiences any of the following side effects, or if they bother your child or do not go away, contact their doctor:
Upset stomach
* Vomiting
Not all possible side effects are listed here. If you have questions or concerns about side effects, consult your child's doctor. For medical advice about side effects, contact your child's doctor.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If your child experiences any of the following symptoms, contact their doctor immediately or seek emergency medical attention. Although rare, some people may have severe and potentially life-threatening side effects when taking this medication. Watch for signs of an allergic reaction, including:
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
Additionally, notify your child's doctor if you notice any changes in the appearance of their teeth or gums.
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If your child experiences any of the following side effects, or if they bother your child or do not go away, contact their doctor:
Upset stomach
* Vomiting
Not all possible side effects are listed here. If you have questions or concerns about side effects, consult your child's doctor. For medical advice about side effects, contact your child's doctor.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Any unusual white spots or brown stains on your child's teeth (signs of dental fluorosis).
- Nausea, vomiting, diarrhea, or stomach upset.
- Headache, irritability, or unusual tiredness.
- Loss of appetite or weight changes.
- Bone or joint pain.
- Dry skin, hair loss, or vision changes (signs of too much Vitamin A).
- Increased thirst or urination (signs of too much Vitamin D).
Before Using This Medicine
Before Your Child Takes This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies your child may have to this medication, its components, or other substances, including foods and drugs. Please describe the allergic reaction and its symptoms.
If your child has a history of certain health conditions, such as bone problems, joint problems, kidney problems, or ulcers.
If your child's drinking water contains sufficient fluoride. If you are unsure, consult with your doctor to determine the appropriate course of action.
This medication may interact with other substances, so it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications your child is taking
Any natural products or vitamins your child is using
Your child's existing health problems
To ensure safe treatment, do not start, stop, or modify the dosage of any medication your child is taking without first consulting with your doctor. This will help prevent potential interactions and ensure the safe use of this medication.
It is essential to inform your doctor about the following:
Any allergies your child may have to this medication, its components, or other substances, including foods and drugs. Please describe the allergic reaction and its symptoms.
If your child has a history of certain health conditions, such as bone problems, joint problems, kidney problems, or ulcers.
If your child's drinking water contains sufficient fluoride. If you are unsure, consult with your doctor to determine the appropriate course of action.
This medication may interact with other substances, so it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications your child is taking
Any natural products or vitamins your child is using
Your child's existing health problems
To ensure safe treatment, do not start, stop, or modify the dosage of any medication your child is taking without first consulting with your doctor. This will help prevent potential interactions and ensure the safe use of this medication.
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 includes discussing the specific brand and formulation of the drug, as different brands may be suitable for different age groups. Before administering this medication to a child, consult with the doctor to ensure the correct dosage and formulation.
Administration and Dosage
Do not exceed the recommended dose or frequency of administration. If you are unsure about the correct dosage for your child, consult with the doctor. The dose 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. Inform all healthcare providers and lab personnel that your child is taking this medication to ensure accurate test results.
Dental Care
Regular dental check-ups are crucial while taking this medication. If your child's teeth become stained or spotted, notify the dentist. Additionally, encourage good oral hygiene practices to maintain your child's dental health.
Safety Precautions
In case of accidental ingestion of a large amount of this medication, seek immediate medical attention or contact a poison control center. To minimize the risk of interactions, avoid giving your child products containing calcium (such as dairy products) or aluminum/magnesium (such as certain antacids) within 2 hours of taking this medication. If your child drinks purified water, note that it may not contain fluoride.
Pregnancy and Breastfeeding
If your child is pregnant, becomes pregnant, or is breastfeeding, consult with the doctor to discuss the potential benefits and risks to both your child and the baby. This will help determine the best course of action for their specific situation.
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 includes discussing the specific brand and formulation of the drug, as different brands may be suitable for different age groups. Before administering this medication to a child, consult with the doctor to ensure the correct dosage and formulation.
Administration and Dosage
Do not exceed the recommended dose or frequency of administration. If you are unsure about the correct dosage for your child, consult with the doctor. The dose 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. Inform all healthcare providers and lab personnel that your child is taking this medication to ensure accurate test results.
Dental Care
Regular dental check-ups are crucial while taking this medication. If your child's teeth become stained or spotted, notify the dentist. Additionally, encourage good oral hygiene practices to maintain your child's dental health.
Safety Precautions
In case of accidental ingestion of a large amount of this medication, seek immediate medical attention or contact a poison control center. To minimize the risk of interactions, avoid giving your child products containing calcium (such as dairy products) or aluminum/magnesium (such as certain antacids) within 2 hours of taking this medication. If your child drinks purified water, note that it may not contain fluoride.
Pregnancy and Breastfeeding
If your child is pregnant, becomes pregnant, or is breastfeeding, consult with the doctor to discuss the potential benefits and risks to both your child and the baby. This will help determine the best course of action for their specific situation.
Overdose Information
Overdose Symptoms:
- Acute fluoride overdose: Nausea, vomiting, abdominal pain, diarrhea, salivation, headache, weakness, muscle spasms, convulsions, cardiac arrhythmias. Severe cases can lead to death.
- Chronic fluoride overdose (fluorosis): Dental fluorosis (mottling, staining of tooth enamel), skeletal fluorosis (bone pain, stiffness, joint deformities).
- Hypervitaminosis A: Dry skin, hair loss, headache, nausea, vomiting, bone pain, irritability, bulging fontanelles in infants.
- Hypervitaminosis D: Hypercalcemia (high blood calcium), leading to nausea, vomiting, constipation, weakness, fatigue, increased thirst and urination, kidney stones, and in severe cases, kidney damage.
What to Do:
In case of suspected overdose, immediately contact a poison control center (call 1-800-222-1222 in the US) or seek emergency medical attention. For acute fluoride overdose, milk or calcium-containing liquids may be given to bind fluoride. Medical management focuses on supportive care and correcting electrolyte imbalances.
Drug Interactions
Major Interactions
- Antacids (calcium, aluminum, magnesium-containing): Can bind fluoride and reduce its absorption. Administer fluoride at least 2 hours before or after antacids.
- Dairy products: Calcium in dairy can bind fluoride and reduce absorption. Administer fluoride at least 1 hour before or after dairy products.
Moderate Interactions
- Retinoids (e.g., isotretinoin, acitretin): Concomitant use with high doses of Vitamin A can increase the risk of hypervitaminosis A.
- Thiazide diuretics: May increase serum calcium levels, potentially increasing the risk of hypercalcemia when taken with high doses of Vitamin D.
- Orlistat, Cholestyramine, Mineral oil: Can reduce absorption of fat-soluble vitamins (A, D).
- Phenytoin, Barbiturates: May increase metabolism of Vitamin D, potentially requiring higher doses.
Minor Interactions
- Iron supplements: High doses of Vitamin C can enhance iron absorption, which may be a concern in patients with hemochromatosis.
- Corticosteroids: May reduce Vitamin D absorption and increase its metabolism.
Monitoring
Baseline Monitoring
Local drinking water fluoride concentration
Rationale: Essential for determining appropriate fluoride supplementation dose to prevent both deficiency and fluorosis.
Timing: Before initiating fluoride supplementation.
Dietary intake assessment
Rationale: To assess overall nutritional status and identify potential deficiencies or excessive intake from other sources.
Timing: Before initiation and periodically.
Routine Monitoring
Dental examination for fluorosis
Frequency: Annually or as recommended by dentist
Target: Absence of dental fluorosis (white flecks or brown staining)
Action Threshold: Presence of mild to severe fluorosis warrants re-evaluation of fluoride intake.
Growth and development
Frequency: Regular pediatric check-ups
Target: Normal growth curves for age
Action Threshold: Failure to thrive or unusual growth patterns may indicate underlying issues or nutritional imbalances.
Signs of hypervitaminosis (A, D)
Frequency: Periodically, especially if high doses are used or symptoms arise
Target: Absence of symptoms
Action Threshold: Symptoms like headache, nausea, vomiting, bone pain, dry skin, irritability, or bulging fontanelles (in infants) warrant immediate medical evaluation and dose adjustment.
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Headache
- Irritability
- Loss of appetite
- Fatigue
- Bone or joint pain
- Dry skin or hair loss (Vitamin A toxicity)
- Increased urination or thirst (Vitamin D toxicity)
- White flecks or brown staining on teeth (dental fluorosis)
Special Patient Groups
Pregnancy
Not indicated for use in pregnant individuals. This product is formulated for pediatric use.
Trimester-Specific Risks:
First Trimester:
Not applicable.
Second Trimester:
Not applicable.
Third Trimester:
Not applicable.
Lactation
Not indicated for use in lactating individuals. This product is formulated for pediatric use.
Infant Risk:
Not applicable.
Pediatric Use
This product is specifically formulated for pediatric use. Dosing must be carefully individualized based on the child's age, weight, and the fluoride concentration in their primary drinking water source to prevent both deficiency and toxicity (especially dental fluorosis). Regular dental check-ups are crucial to monitor for signs of fluorosis.
Geriatric Use
Not indicated for geriatric use.
Clinical Information
Clinical Pearls
- Always confirm the fluoride concentration in the child's primary drinking water source (tap water, bottled water) before initiating fluoride supplementation. This is critical to prevent dental fluorosis.
- Educate parents on the importance of using the provided dropper for accurate dosing and not exceeding the recommended daily dose.
- Advise parents to store the product safely out of reach of children, as overdose, especially of fluoride and fat-soluble vitamins, can be serious.
- Emphasize that this supplement is an adjunct to, not a replacement for, a balanced diet and good oral hygiene practices.
- Monitor for early signs of dental fluorosis (e.g., faint white streaks or spots on tooth enamel) and advise parents to consult a dentist if observed.
Alternative Therapies
- Dietary modifications to ensure adequate vitamin intake
- Community water fluoridation (the most effective public health measure for caries prevention)
- Topical fluoride applications (varnishes, gels) by a dental professional
- Fluoride toothpaste (age-appropriate concentration and amount)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$30 per 50ml bottle
Generic Available:
Yes
Insurance Coverage:
Generally OTC, not typically covered by insurance unless prescribed and specific plan benefits allow.
General Drug Facts
If your child's symptoms or health issues persist or worsen, it is essential to contact their doctor promptly. To ensure safety and efficacy, 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 accompanying patient information leaflet, if available. Alternatively, you can discuss any questions or concerns with your child's healthcare team, including their doctor, nurse, pharmacist, or other healthcare provider. It is also advisable to verify with your pharmacist if an additional patient information leaflet is available for this medication. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the substance taken, the quantity, and the time of occurrence.