Poly-Vi-flor 0.25mg W/fe Drops 50ml
WARNING: Accidental overdose of drugs that have iron in them is a leading cause of deadly poisoning in children younger than 6 years of age. Keep away from children. If this drug is taken by accident, call a doctor or poison control center right away. @ COMMON USES: It is used to help growth and good health.Fluoride may be in the vitamin to prevent tooth decay.
Drug Class
Multivitamin, Mineral Supplement, Dental Caries Prophylaxis, Iron Supplement
Pharmacologic Class
Vitamin/Mineral Combination, Fluoride Salt, Iron Salt
Pregnancy Category
Not applicable (pediatric formulation); individual components vary (e.g., Iron: A, Fluoride: B, most vitamins: A/C)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medicine is a liquid vitamin supplement for babies and young children. It contains important vitamins for growth, iron to help prevent anemia, and fluoride to help make teeth strong and prevent cavities. It's especially for children who don't get enough fluoride from their drinking water.
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. You can give this medication with or without food. If it causes stomach upset, administer it with food to help alleviate this issue.
It's essential to note that some medications must be taken with food or on an empty stomach, while others have no specific requirements. Consult with your pharmacist to determine the best approach for your child's medication.
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. Be sure to understand the correct administration method for your child's specific medication.
Storing and Disposing of This Medication
Store the medication in its original container at room temperature, in a dry location away from bathrooms. Protect the medication from heat and light to maintain its effectiveness.
Missing a Dose
If you miss 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 cause adverse effects.
To ensure your child takes this medication correctly, follow the instructions provided by their doctor and read all accompanying information carefully. You can give this medication with or without food. If it causes stomach upset, administer it with food to help alleviate this issue.
It's essential to note that some medications must be taken with food or on an empty stomach, while others have no specific requirements. Consult with your pharmacist to determine the best approach for your child's medication.
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. Be sure to understand the correct administration method for your child's specific medication.
Storing and Disposing of This Medication
Store the medication in its original container at room temperature, in a dry location away from bathrooms. Protect the medication from heat and light to maintain its effectiveness.
Missing a Dose
If you miss 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 cause adverse effects.
Lifestyle & Tips
- Administer the dose directly into the child's mouth using the provided dropper, or mix with formula, cereal, or juice. Do not mix with milk or other dairy products as this can reduce iron absorption.
- Do not exceed the recommended dose. More is not better and can be harmful.
- Store the bottle tightly closed at room temperature, away from light and moisture.
- Keep this product, and all medicines, out of the reach and sight of children, preferably in a locked cabinet. Iron overdose is very dangerous for children.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not applicable (pediatric formulation)
Pediatric Dosing
Neonatal:
Not established (typically not recommended for infants under 6 months unless specific deficiency diagnosed)
Infant:
For infants 6 months to 3 years of age: 1 mL daily, or as directed by a physician. Dosing is dependent on local water fluoridation levels (typically for areas with <0.3 ppm fluoride).
Child:
For children 3 to 6 years of age: 1 mL daily, or as directed by a physician. Dosing is dependent on local water fluoridation levels (typically for areas with <0.3 ppm fluoride). Note: Some guidelines recommend 0.5 mg fluoride for 3-6 years, so this 0.25mg product may require adjustment or a different product.
Adolescent:
Not typically indicated for adolescents due to lower fluoride content (0.25mg) and specific vitamin/mineral needs; higher fluoride doses (1.0mg) are usually recommended for this age group in low-fluoride areas.
Dose Adjustments
Renal Impairment:
Mild:
Caution advised; monitor fluoride levels. Fluoride is primarily renally excreted.
Moderate:
Caution advised; monitor fluoride levels. Potential for fluoride accumulation. Consult a nephrologist.
Severe:
Contraindicated or used with extreme caution due to risk of fluoride accumulation and toxicity. Consult a nephrologist.
Dialysis:
Contraindicated due to risk of fluoride accumulation and toxicity.
Hepatic Impairment:
Mild:
Generally no specific adjustment for vitamins/fluoride. Caution with iron in patients with hemochromatosis or severe liver disease.
Moderate:
Caution with iron in patients with hemochromatosis or severe liver disease. Monitor iron status.
Severe:
Caution with iron in patients with hemochromatosis or severe liver disease. Monitor iron status. Avoid if hemochromatosis is present.
Pharmacology
Mechanism of Action
This product provides essential vitamins (acting as coenzymes in metabolic processes, antioxidants, etc.), iron (essential component of hemoglobin, myoglobin, and various enzymes involved in oxygen transport and cellular respiration), and fluoride (promotes remineralization of tooth enamel, inhibits demineralization, and has antibacterial effects against oral pathogens, thereby preventing dental caries).
Pharmacokinetics
Absorption:
Bioavailability:
Variable for individual components (e.g., iron absorption 5-15%, fluoride absorption >90%).
Tmax:
Variable for individual components (e.g., iron 2-4 hours, fluoride 30-60 minutes).
FoodEffect:
Iron absorption is decreased by food, especially dairy, tea, coffee, and high-fiber foods. Fluoride absorption can be reduced by calcium-containing foods/supplements. Vitamin absorption can be enhanced or reduced by food depending on the vitamin (e.g., fat-soluble vitamins with fat).
Distribution:
Vd:
Variable for individual components (e.g., iron widely distributed, fluoride distributed to mineralized tissues like bone and teeth).
ProteinBinding:
Variable (e.g., iron binds to transferrin, fluoride minimally protein bound).
CnssPenetration:
Limited for most components; fluoride can cross the blood-brain barrier to a limited extent.
Elimination:
HalfLife:
Variable (e.g., iron has no true half-life, fluoride 2-9 hours in adults, longer in children).
Clearance:
Variable; iron primarily excreted via GI tract (desquamation), fluoride primarily renal.
ExcretionRoute:
Iron: Feces (unabsorbed), desquamation of cells. Fluoride: Urine (primary), feces (unabsorbed), sweat. Vitamins: Urine (water-soluble), feces (fat-soluble, unabsorbed).
Unchanged:
Fluoride: High percentage renally excreted unchanged. Iron: Not excreted unchanged in significant amounts.
Pharmacodynamics
OnsetOfAction:
Chronic supplementation; effects on growth, development, and dental health are gradual.
PeakEffect:
Not applicable for chronic supplementation.
DurationOfAction:
Continuous with daily dosing.
Safety & Warnings
BLACK BOX WARNING
ACCIDENTAL OVERDOSE OF IRON-CONTAINING PRODUCTS IS A LEADING CAUSE OF FATAL POISONING IN CHILDREN UNDER 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, CALL A DOCTOR OR POISON CONTROL CENTER IMMEDIATELY.
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If your child experiences any of the following symptoms, contact their doctor immediately or seek medical attention:
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
Change in the appearance of teeth or gums
Black, tarry, or bloody stools
Fever
Vomiting blood or coffee ground-like material
Stomach cramps
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people may not experience any side effects or may 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 or vomiting
Diarrhea or constipation
Green-colored stool
Stomach pain
* Darkening of teeth (regular brushing can help minimize this effect)
Reporting Side Effects
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your child's doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If your child experiences any of the following symptoms, contact their doctor immediately or seek medical attention:
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
Change in the appearance of teeth or gums
Black, tarry, or bloody stools
Fever
Vomiting blood or coffee ground-like material
Stomach cramps
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people may not experience any side effects or may 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 or vomiting
Diarrhea or constipation
Green-colored stool
Stomach pain
* Darkening of teeth (regular brushing can help minimize this effect)
Reporting Side Effects
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your child's doctor. You can also 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:
- Signs of overdose: severe vomiting, diarrhea, stomach pain, drowsiness, pale skin, blue lips/nails. Seek immediate medical attention.
- Signs of allergic reaction: rash, itching, swelling, severe dizziness, trouble breathing.
- Signs of fluorosis: white spots or streaks on teeth (usually mild and cosmetic, but indicates excessive fluoride intake).
Before Using This Medicine
Before Giving This Medication to Your Child: 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 conditions, 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 fluoride levels.
- Your child has elevated iron levels in the body.
Important: This list does not encompass all potential interactions with this medication. It is crucial to 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 health problems. Ensure that it is safe to administer this medication alongside your child's other medications and health conditions. Never start, stop, or adjust the dosage of any medication 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 conditions, 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 fluoride levels.
- Your child has elevated iron levels in the body.
Important: This list does not encompass all potential interactions with this medication. It is crucial to 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 health problems. Ensure that it is safe to administer this medication alongside your child's other medications and health conditions. Never start, stop, or adjust the dosage of any medication 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 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 dose for your child, consult with the 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 affect the results of 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 essential to maintain your child's oral health. If your child's teeth become stained or spotted, notify the 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, 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 of this medication to both your child and the baby.
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 dose for your child, consult with the 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 affect the results of 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 essential to maintain your child's oral health. If your child's teeth become stained or spotted, notify the 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, 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 of this medication to both your child and the baby.
Overdose Information
Overdose Symptoms:
- Initial symptoms (within 6 hours): Nausea, vomiting, diarrhea (often bloody), abdominal pain, lethargy, pallor.
- Latent period (6-24 hours): Apparent improvement.
- Late symptoms (12-48 hours): Metabolic acidosis, shock, hepatic necrosis, coagulopathy, renal failure, cardiovascular collapse, coma, death.
What to Do:
IMMEDIATELY call a Poison Control Center (1-800-222-1222) or emergency services. Do not induce vomiting. Take the product container with you to the emergency room. Treatment may involve gastric lavage, whole bowel irrigation, chelation therapy (e.g., deferoxamine) for iron, and supportive care.
Drug Interactions
Major Interactions
- Iron with tetracyclines/fluoroquinolones (decreased antibiotic absorption)
- Iron with levothyroxine (decreased thyroid hormone absorption)
- Fluoride with antacids containing calcium, aluminum, or magnesium (decreased fluoride absorption)
Moderate Interactions
- Iron with proton pump inhibitors/H2 blockers (decreased iron absorption due to reduced gastric acidity)
- Iron with calcium supplements (decreased iron absorption)
- Iron with cholestyramine (decreased iron absorption)
- Vitamin C (ascorbic acid) can enhance iron absorption.
- Vitamin E can antagonize Vitamin K activity (theoretical with high doses).
- Vitamin B6 (pyridoxine) can reduce levodopa efficacy (not typically an issue with multivitamin doses).
Minor Interactions
- Certain foods (e.g., dairy, tea, coffee, high-fiber) can reduce iron absorption.
- Excessive intake of certain minerals can interfere with absorption of others.
Monitoring
Baseline Monitoring
Assessment of dietary intake and water fluoridation level
Rationale: To determine the need for supplementation and appropriate fluoride dose.
Timing: Prior to initiation of therapy
Growth and development assessment
Rationale: To establish baseline and monitor overall health.
Timing: Prior to initiation of therapy
Iron status (e.g., hemoglobin, ferritin) if iron deficiency is suspected or for high-risk infants
Rationale: To guide iron supplementation and prevent overdose.
Timing: Prior to initiation of therapy, if indicated
Routine Monitoring
Growth parameters (weight, height/length, head circumference)
Frequency: Regular pediatric check-ups (e.g., every 3-6 months for infants/toddlers)
Target: Within age-appropriate percentiles
Action Threshold: Failure to thrive, significant deviation from growth curve
Dental examination
Frequency: Annually or as recommended by dentist
Target: Absence of dental caries, signs of fluorosis
Action Threshold: Presence of caries, signs of fluorosis (e.g., white flecks on teeth)
Signs of iron deficiency or toxicity
Frequency: Ongoing parental observation; clinical assessment at check-ups
Target: Normal energy levels, no pallor; no signs of overdose
Action Threshold: Fatigue, pallor, pica; or vomiting, diarrhea, abdominal pain (signs of overdose)
Symptom Monitoring
- Signs of iron overdose (vomiting, diarrhea, abdominal pain, lethargy, pallor, shock, metabolic acidosis)
- Signs of vitamin toxicity (e.g., hypervitaminosis A: irritability, anorexia, dry skin, hair loss; hypervitaminosis D: hypercalcemia, nausea, vomiting)
- Signs of fluorosis (white flecks, streaks, or pitting on tooth enamel)
- Allergic reactions (rare)
Special Patient Groups
Pregnancy
Not indicated for use in pregnant individuals as it is a pediatric formulation. Pregnant individuals should take prenatal vitamins as recommended by their healthcare provider.
Trimester-Specific Risks:
First Trimester:
Not applicable
Second Trimester:
Not applicable
Third Trimester:
Not applicable
Lactation
Not indicated for use in lactating individuals as it is a pediatric formulation. Lactating individuals should consult their healthcare provider regarding appropriate vitamin/mineral supplementation.
Infant Risk:
Not applicable
Pediatric Use
This product is specifically formulated for pediatric use, particularly for infants and young children. Dosing must be carefully determined based on age, weight, and local water fluoridation levels to prevent both deficiency and toxicity (especially iron and fluoride). Close monitoring for signs of overdose is critical.
Geriatric Use
Not indicated for geriatric use.
Clinical Information
Clinical Pearls
- Always verify the child's age and local water fluoridation levels before recommending or administering fluoride-containing supplements to prevent dental fluorosis or inadequate prophylaxis.
- Emphasize the critical importance of safe storage for iron-containing products to prevent accidental poisoning in children.
- Educate parents that iron absorption is best on an empty stomach, but if gastric upset occurs, it can be given with food (avoiding dairy).
- This product is a supplement, not a substitute for a balanced diet. Encourage healthy eating habits.
- Be aware of potential drug-nutrient interactions, especially with iron and certain medications (e.g., antibiotics, thyroid hormones).
Alternative Therapies
- Dietary modifications to increase vitamin and mineral intake.
- Fluoridated water (if available and sufficient).
- Topical fluoride applications (e.g., toothpaste, varnishes) for dental caries prevention.
Cost & Coverage
Average Cost:
$10 - $25 per 50ml bottle
Generic Available:
Yes
Insurance Coverage:
Often OTC, may be covered by some FSA/HSA plans. Rarely covered by prescription drug plans unless prescribed for specific medical necessity.
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 detailed 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 emergency medical attention. When seeking help, be prepared to provide crucial information, including the name of the medication taken, the amount, and the time it occurred.