Quflora FE Pediatric 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
Nutritional Supplement; Vitamin and Mineral Supplement
Pharmacologic Class
Multivitamin; Iron Supplement; Fluoride Supplement
Pregnancy Category
Not applicable (pediatric product)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Quflora FE Pediatric Drops is a liquid supplement for babies and young children. It provides essential vitamins for healthy growth, iron to help prevent anemia, and fluoride to strengthen teeth and protect against 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 administering a liquid dose, measure it accurately using the device provided with the medication. Before use, 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.
Storing and Disposing of This Medication
Store the medication in its original container at room temperature, in a dry location, and away from heat and light. Do not store it in a bathroom. This will help maintain the medication's effectiveness.
Missing a Dose
If you miss a dose, give it to your child 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 administering a liquid dose, measure it accurately using the device provided with the medication. Before use, 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.
Storing and Disposing of This Medication
Store the medication in its original container at room temperature, in a dry location, and away from heat and light. Do not store it in a bathroom. This will help maintain the medication's effectiveness.
Missing a Dose
If you miss a dose, give it to your child 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
- Administer dose accurately using the provided dropper.
- Do not exceed the recommended dose, especially for iron and fluoride, due to toxicity risks.
- Store out of reach of children, as iron overdose is a leading cause of poisoning deaths in young children.
- Administer directly into the mouth or mix with formula, juice, or cereal (avoid milk as it can inhibit iron absorption).
- Brush child's teeth regularly, especially after fluoride administration, to ensure proper dental hygiene.
- Continue regular dental check-ups.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not applicable (pediatric product)
Pediatric Dosing
Neonatal:
Not established (consult pediatrician)
Infant:
Typically 0.25 mL to 1 mL daily, depending on age, weight, and specific product formulation/concentration of iron and fluoride. Dosing must be individualized based on fluoride content of local water supply and dietary iron intake. Consult pediatrician.
Child:
Typically 0.5 mL to 1 mL daily, depending on age, weight, and specific product formulation/concentration of iron and fluoride. Dosing must be individualized based on fluoride content of local water supply and dietary iron intake. Consult pediatrician.
Adolescent:
Not typically indicated for routine supplementation in this age group unless specific deficiencies are identified. Consult pediatrician.
Dose Adjustments
Renal Impairment:
Mild:
Consult physician; potential for fluoride accumulation.
Moderate:
Consult physician; potential for fluoride accumulation. Dose adjustment likely needed.
Severe:
Contraindicated or used with extreme caution due to risk of fluoride and iron accumulation. Consult nephrologist.
Dialysis:
Contraindicated or used with extreme caution due to risk of fluoride and iron accumulation. Consult nephrologist.
Hepatic Impairment:
Mild:
Generally no specific adjustment for vitamins/minerals, but monitor for iron accumulation in severe cases.
Moderate:
Generally no specific adjustment for vitamins/minerals, but monitor for iron accumulation in severe cases.
Severe:
Generally no specific adjustment for vitamins/minerals, but monitor for iron accumulation in severe cases.
Pharmacology
Mechanism of Action
Provides essential vitamins (e.g., A, C, D, E, B-complex) necessary for normal growth, development, and metabolic functions. Iron is crucial for hemoglobin synthesis and oxygen transport. Fluoride aids in the mineralization of developing teeth and bones, increasing resistance to dental caries.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (depends on specific vitamin/mineral, formulation, and presence of other dietary components)
Tmax:
Not specifically quantified for this combination product
FoodEffect:
Absorption of some vitamins (e.g., fat-soluble) is enhanced with food. Iron absorption can be affected by food (e.g., vitamin C enhances, calcium inhibits).
Distribution:
Vd:
Not specifically quantified for this combination product
ProteinBinding:
Variable (e.g., iron binds to transferrin)
CnssPenetration:
Limited for most components, except for specific active transport mechanisms for certain vitamins.
Elimination:
HalfLife:
Variable (hours to days for individual components)
Clearance:
Variable (renal for water-soluble vitamins and fluoride; fecal for unabsorbed iron)
ExcretionRoute:
Renal, fecal
Unchanged:
Variable (e.g., significant portion of fluoride is excreted unchanged)
Pharmacodynamics
OnsetOfAction:
Gradual (nutritional effects are cumulative)
PeakEffect:
Not acutely defined for chronic supplementation
DurationOfAction:
Not acutely defined for chronic supplementation
Safety & Warnings
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 emergency 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
Changes 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. While many people may not experience any side effects or only mild ones, it's essential to monitor your child's condition. If your child experiences any of the following side effects or if they persist or bother your child, contact their doctor:
Upset stomach or vomiting
Diarrhea or constipation
Green-colored stools
Stomach pain
* Darkening of teeth (regular brushing can help minimize this effect)
Reporting Side Effects
This list is not exhaustive, and your child may experience other side effects. If you have questions or concerns about side effects, consult 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 emergency 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
Changes 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. While many people may not experience any side effects or only mild ones, it's essential to monitor your child's condition. If your child experiences any of the following side effects or if they persist or bother your child, contact their doctor:
Upset stomach or vomiting
Diarrhea or constipation
Green-colored stools
Stomach pain
* Darkening of teeth (regular brushing can help minimize this effect)
Reporting Side Effects
This list is not exhaustive, and your child may experience other side effects. If you have questions or concerns about side effects, consult 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:
- Severe stomach pain, nausea, vomiting, diarrhea (especially if bloody or black)
- Drowsiness, lethargy, pale skin, rapid breathing (signs of iron overdose)
- White or brown spots on teeth (signs of dental fluorosis from too much fluoride)
- Unusual fatigue, pallor (signs of iron deficiency if not adequately treated)
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 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 fluoride levels.
- Your child has an excessive amount of iron in their body.
Important: This list does not encompass all potential interactions between this medication and other drugs or health conditions. 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 existing health problems. To ensure safety, always verify that it is safe to administer this medication alongside your child's other medications and health conditions. Never initiate, cease, 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 fluoride levels.
- Your child has an excessive amount of iron in their body.
Important: This list does not encompass all potential interactions between this medication and other drugs or health conditions. 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 existing health problems. To ensure safety, always verify that it is safe to administer this medication alongside your child's other medications and health conditions. Never initiate, cease, 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. The dosage may vary depending on your child's age, so it is crucial to consult with the doctor if you are unsure about the correct dose.
Lab Tests and Interactions
This medication may interfere with certain laboratory tests, so it is vital to inform all healthcare providers and lab workers 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 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 administering this medication. Also, note that purified water 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 you make an informed decision about continuing treatment.
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. The dosage may vary depending on your child's age, so it is crucial to consult with the doctor if you are unsure about the correct dose.
Lab Tests and Interactions
This medication may interfere with certain laboratory tests, so it is vital to inform all healthcare providers and lab workers 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 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 administering this medication. Also, note that purified water 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 you make an informed decision about continuing treatment.
Overdose Information
Overdose Symptoms:
- Iron overdose: Initial symptoms include nausea, vomiting, abdominal pain, diarrhea (may be bloody). Can progress to lethargy, shock, metabolic acidosis, liver damage, and death.
- Fluoride overdose: Nausea, vomiting, abdominal pain, muscle weakness, tremors, convulsions, cardiac arrest. Chronic overdose leads to dental fluorosis (mottling of teeth) and skeletal fluorosis.
What to Do:
IMMEDIATELY call Poison Control (1-800-222-1222) or seek emergency medical attention. For iron overdose, treatment may involve gastric lavage, chelation therapy (e.g., deferoxamine), and supportive care. For fluoride overdose, calcium administration (milk, calcium gluconate) may be used to bind fluoride, along with supportive care.
Drug Interactions
Major Interactions
- Tetracyclines (decreased absorption of iron)
- Quinolone antibiotics (decreased absorption of iron)
- Levothyroxine (decreased absorption of levothyroxine by iron)
- Antacids/Calcium supplements (decreased absorption of iron and fluoride)
Moderate Interactions
- Bisphosphonates (decreased absorption by iron)
- Penicillamine (decreased absorption by iron)
- Chloramphenicol (may interfere with iron utilization)
- Vitamin K antagonists (e.g., warfarin) - high doses of Vitamin E or A may increase bleeding risk, though unlikely with typical supplement doses.
Minor Interactions
- Dietary fiber (may reduce iron absorption)
- Phytates/Oxalates (may reduce iron absorption)
Monitoring
Baseline Monitoring
Dietary intake assessment (iron, fluoride, vitamins)
Rationale: To determine need for supplementation and appropriate dosing.
Timing: Prior to initiation
Local water fluoride concentration
Rationale: Crucial for appropriate fluoride dosing to prevent fluorosis.
Timing: Prior to initiation
Routine Monitoring
Growth and development
Frequency: Regular pediatric check-ups
Target: Normal growth curves
Action Threshold: Deviation from normal growth patterns
Dental examination (for fluorosis)
Frequency: Annually or as recommended by dentist
Target: Absence of dental fluorosis
Action Threshold: Presence of white flecks or brown staining on teeth
Hemoglobin/Hematocrit (if iron deficiency suspected)
Frequency: As clinically indicated
Target: Age-appropriate normal ranges
Action Threshold: Anemia
Symptom Monitoring
- Signs of iron deficiency (pallor, fatigue, pica)
- Signs of iron toxicity (nausea, vomiting, abdominal pain, diarrhea, lethargy, shock)
- Signs of fluoride toxicity (dental fluorosis, nausea, vomiting, abdominal pain, muscle weakness, convulsions)
- Signs of hypervitaminosis (e.g., Vitamin A: dry skin, hair loss, liver toxicity; Vitamin D: hypercalcemia)
Special Patient Groups
Pregnancy
Not applicable (pediatric product).
Trimester-Specific Risks:
First Trimester:
Not applicable
Second Trimester:
Not applicable
Third Trimester:
Not applicable
Lactation
Not applicable (pediatric product).
Infant Risk:
Not applicable
Pediatric Use
This product is specifically formulated for pediatric use. Dosing must be carefully determined by a healthcare professional based on the child's age, weight, dietary intake, and local water fluoride concentration to prevent both deficiency and toxicity (especially iron and fluoride).
Geriatric Use
Not applicable (pediatric product).
Clinical Information
Clinical Pearls
- Iron overdose is a leading cause of poisoning deaths in children under 6 years old. Emphasize strict storage out of reach of children.
- Fluoride dosing must be carefully calculated based on the child's age and the fluoride content of the local drinking water supply to prevent dental fluorosis.
- Educate parents on the importance of accurate dosing using the provided dropper and not exceeding the recommended amount.
- Advise parents to administer iron supplements between meals if tolerated, or with food to minimize GI upset, but avoid milk or calcium-rich foods as they can inhibit iron absorption.
- Regular dental check-ups are essential to monitor for signs of dental fluorosis.
Alternative Therapies
- Dietary modifications to increase vitamin and mineral intake
- Single-entity iron supplements (e.g., ferrous sulfate drops)
- Single-entity fluoride supplements (e.g., sodium fluoride drops/tablets)
- Fluoridated water supply (for fluoride intake)
Cost & Coverage
Average Cost:
$10 - $30 per 50ml bottle
Generic Available:
Yes
Insurance Coverage:
Often over-the-counter; may be covered by some insurance plans with prescription or 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 and effective treatment, 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.