Vitafol Gummies 3.33-0.333-34.8mg
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: This vitamin is used to aid the diet needs before, during, and after pregnancy.
Drug Class
Vitamin/Mineral Supplement; Prenatal Supplement
Pharmacologic Class
Multivitamin; Mineral Supplement
Pregnancy Category
Not applicable (Dietary Supplement, intended for use in pregnancy)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vitafol Gummies are a type of prenatal vitamin, which is a daily supplement designed to provide essential vitamins and minerals for women who are pregnant, trying to conceive, or breastfeeding. They help support the health of both the mother and the developing baby, ensuring proper growth and preventing certain birth defects, especially neural tube defects.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Check with your pharmacist to determine if your medication should be taken with food, on an empty stomach, or if it doesn't matter.
Swallow your medication with a full glass of water.
Avoid taking antacids within 2 hours before or 2 hours after taking your medication.
Do not consume dairy products with your medication, as they may reduce its effectiveness.
Chew your medication thoroughly before swallowing.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature, protected from light.
Keep it in a dry place, away from bathrooms.
Protect it from heat sources.
Keep all medications in a safe and secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, follow these guidelines:
Take the missed dose as soon as you remember.
If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed one.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Check with your pharmacist to determine if your medication should be taken with food, on an empty stomach, or if it doesn't matter.
Swallow your medication with a full glass of water.
Avoid taking antacids within 2 hours before or 2 hours after taking your medication.
Do not consume dairy products with your medication, as they may reduce its effectiveness.
Chew your medication thoroughly before swallowing.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature, protected from light.
Keep it in a dry place, away from bathrooms.
Protect it from heat sources.
Keep all medications in a safe and secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, follow these guidelines:
Take the missed dose as soon as you remember.
If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take as directed, usually once daily.
- Take with food to minimize stomach upset and improve absorption.
- Store in a cool, dry place, away from direct sunlight and moisture.
- Keep out of reach of children, especially iron-containing products.
- Maintain a balanced diet in addition to taking the supplement.
- Stay hydrated.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Refer to product label for specific dosing instructions, typically 1-2 gummies daily.
Condition-Specific Dosing:
pregnancy:
As directed by healthcare provider or product label.
lactation:
As directed by healthcare provider or product label.
Pediatric Dosing
Neonatal:
Not established (Not intended for neonatal use)
Infant:
Not established (Not intended for infant use)
Child:
Not established (Not intended for child use, unless specifically formulated for pediatric use and directed by a physician)
Adolescent:
Not established (Not typically indicated for adolescents unless pregnant or lactating, or under specific medical advice)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required for standard dosing, but caution with specific mineral excesses (e.g., potassium, phosphorus) if present in high amounts.
Moderate:
No specific adjustment required for standard dosing, but caution with specific mineral excesses (e.g., potassium, phosphorus) if present in high amounts.
Severe:
Use with caution; consult healthcare provider. Accumulation of certain minerals (e.g., potassium, phosphorus, magnesium) can occur in severe renal impairment. Specific vitamin levels may also need monitoring.
Dialysis:
Consult healthcare provider. Specific vitamin and mineral needs may vary in dialysis patients; standard prenatal vitamins may not be appropriate without adjustment.
Hepatic Impairment:
Mild:
No specific adjustment required for standard dosing.
Moderate:
No specific adjustment required for standard dosing.
Severe:
No specific adjustment required for standard dosing, but monitor for fat-soluble vitamin levels if cholestasis is present.
Pharmacology
Mechanism of Action
Prenatal vitamins provide essential vitamins and minerals necessary for maternal health and fetal development. They act as cofactors for various enzymatic reactions, structural components for tissues, and play critical roles in cell growth, differentiation, and metabolic processes. Key components like folic acid prevent neural tube defects, iron supports red blood cell formation and oxygen transport, and calcium and vitamin D are crucial for bone development.
Pharmacokinetics
Absorption:
Bioavailability:
Varies significantly by individual vitamin/mineral component and formulation (e.g., iron absorption is enhanced by Vitamin C, inhibited by calcium).
Tmax:
Not typically defined for multivitamin supplements; absorption is continuous over several hours post-ingestion.
FoodEffect:
Generally recommended to be taken with food to enhance absorption of fat-soluble vitamins and minimize gastrointestinal upset (especially with iron).
Distribution:
Vd:
Not applicable for a multi-component supplement; individual components distribute widely throughout body tissues.
ProteinBinding:
Varies by individual vitamin/mineral (e.g., Vitamin D binds to DBP, Vitamin B12 to transcobalamins).
CnssPenetration:
Yes, essential vitamins and minerals cross the blood-brain barrier to support neurological function.
Elimination:
HalfLife:
Varies widely by individual vitamin/mineral (e.g., minutes for some water-soluble, days to months for fat-soluble).
Clearance:
Varies by individual vitamin/mineral; primarily renal for water-soluble, biliary/fecal for fat-soluble.
ExcretionRoute:
Primarily renal for water-soluble vitamins; primarily biliary/fecal for fat-soluble vitamins and some minerals.
Unchanged:
Varies; significant for some water-soluble vitamins.
Pharmacodynamics
OnsetOfAction:
Not acutely defined; benefits are cumulative over time with consistent supplementation.
PeakEffect:
Not acutely defined; reflects sustained nutritional support.
DurationOfAction:
Continuous with daily supplementation; body stores of some vitamins (e.g., fat-soluble) can last longer.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help 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
Black, tarry, or bloody stools
Fever
Vomiting blood or material that looks like coffee grounds
Stomach cramps
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Heartburn
Change in stool color to green
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or 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 you notice any of the following symptoms, contact your doctor or seek medical help 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
Black, tarry, or bloody stools
Fever
Vomiting blood or material that looks like coffee grounds
Stomach cramps
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Heartburn
Change in stool color to green
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your 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 or cramping
- Persistent nausea or vomiting
- Severe constipation or diarrhea
- Allergic reaction symptoms (rash, itching, swelling, severe dizziness, trouble breathing)
- Signs of iron overdose (severe stomach pain, vomiting, diarrhea, pale or bluish skin, weakness, shallow breathing, rapid heartbeat, drowsiness, seizures) - seek immediate medical attention.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced
If you have an iron overload in your body
If you have certain types of anemia, such as pernicious anemia, which is characterized by a vitamin B12 deficiency
If you are currently taking mineral oil
If you are taking levodopa
If you are taking acitretin
Additionally, if your medication contains omega-3 fatty acids, you should also inform your doctor if:
You are taking anticoagulant medications (blood thinners)
You have a bleeding disorder
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced
If you have an iron overload in your body
If you have certain types of anemia, such as pernicious anemia, which is characterized by a vitamin B12 deficiency
If you are currently taking mineral oil
If you are taking levodopa
If you are taking acitretin
Additionally, if your medication contains omega-3 fatty acids, you should also inform your doctor if:
You are taking anticoagulant medications (blood thinners)
You have a bleeding disorder
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug may interfere with certain laboratory tests, so be sure to notify your healthcare providers and laboratory personnel that you are taking it. If you have phenylketonuria (PKU), consult with your doctor, as some formulations of this medication may contain phenylalanine. Additionally, if you are breastfeeding, discuss the potential risks to your baby with your doctor to determine the best course of action.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Stomach pain
- Constipation
- Fatigue
- Headache
- Muscle weakness
- Blurred vision
- Hair loss
- Joint pain
- Liver damage (with excessive fat-soluble vitamins like A, D, E, K)
- Iron toxicity (severe GI upset, metabolic acidosis, shock, liver failure, coma, death)
What to Do:
In case of suspected overdose, especially with iron, seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment may involve supportive care, gastric lavage, chelation therapy for iron, or other specific interventions depending on the nutrient and severity of overdose.
Drug Interactions
Major Interactions
- Levothyroxine (calcium and iron can impair absorption; separate administration by at least 4 hours)
- Tetracyclines/Fluoroquinolones (calcium, iron, magnesium, zinc can chelate, reducing antibiotic absorption; separate administration by at least 2-6 hours)
- Antacids (calcium and magnesium in antacids can interfere with iron absorption; iron can interfere with antacid efficacy)
Moderate Interactions
- Bisphosphonates (calcium and iron can impair absorption; separate administration)
- Phenytoin/Carbamazepine/Phenobarbital (may increase folic acid metabolism, potentially reducing efficacy; monitor folic acid levels)
- Warfarin (Vitamin K can reduce anticoagulant effect; prenatal vitamins typically contain low or no Vitamin K, but check label)
- Diuretics (thiazide diuretics can increase calcium reabsorption; loop diuretics can increase calcium excretion)
- Cholestyramine/Colestipol (can impair absorption of fat-soluble vitamins)
Minor Interactions
- Proton Pump Inhibitors/H2 Blockers (may reduce absorption of Vitamin B12 and iron due to reduced gastric acid)
- Orlistat (can reduce absorption of fat-soluble vitamins; separate administration)
Monitoring
Baseline Monitoring
Dietary intake assessment
Rationale: To understand baseline nutritional status and identify potential deficiencies or excesses.
Timing: Prior to starting supplementation.
Hemoglobin/Hematocrit (if indicated)
Rationale: To assess for anemia, especially iron-deficiency anemia, which is common in pregnancy.
Timing: As part of routine prenatal care.
Serum Vitamin D levels (if indicated)
Rationale: To assess for Vitamin D deficiency, which is common and important for maternal and fetal bone health.
Timing: As part of routine prenatal care or if risk factors for deficiency are present.
Routine Monitoring
Adherence to dosing
Frequency: Daily
Target: Consistent daily intake
Action Threshold: Inconsistent intake; counsel on importance.
Tolerance/Adverse effects (e.g., nausea, constipation)
Frequency: Ongoing
Target: Minimal to no side effects
Action Threshold: Persistent or severe side effects; consider alternative formulation or timing.
Symptom Monitoring
- Nausea
- Constipation
- Diarrhea
- Stomach upset
- Dark stools (due to iron)
- Allergic reactions (rare, e.g., rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Prenatal vitamins are specifically formulated and recommended for use before, during, and after pregnancy to ensure adequate nutrient intake for both maternal health and fetal development. Folic acid is particularly critical to prevent neural tube defects.
Trimester-Specific Risks:
First Trimester:
Crucial for neural tube development (folic acid) and organogenesis. Adequate intake of all nutrients is vital.
Second Trimester:
Supports rapid fetal growth and development, including bone formation (calcium, Vitamin D) and red blood cell production (iron).
Third Trimester:
Continues to support fetal growth, brain development, and prepares the mother's body for labor and delivery.
Lactation
Continued use of prenatal vitamins is generally recommended during lactation to support the mother's nutritional needs and ensure adequate nutrient transfer to breast milk for infant growth and development.
Infant Risk:
L1 (Compatible with breastfeeding). No known risk to the infant when taken at recommended doses. Provides essential nutrients to the infant via breast milk.
Pediatric Use
Not typically indicated for general pediatric use. Specific pediatric multivitamin formulations are available if needed, but prenatal vitamins are designed for adult women of childbearing age.
Geriatric Use
Not specifically indicated for geriatric use. Geriatric individuals have different nutritional needs; a standard multivitamin formulated for seniors would be more appropriate if supplementation is required.
Clinical Information
Clinical Pearls
- Emphasize the importance of consistent daily intake, especially folic acid, starting at least one month prior to conception.
- Advise patients that iron in prenatal vitamins can cause constipation and dark stools; recommend increasing fiber and fluid intake.
- Suggest taking the gummy with a meal to reduce nausea and improve absorption.
- Remind patients that prenatal vitamins are supplements and do not replace a healthy, balanced diet.
- Counsel on proper storage to prevent accidental ingestion by children, particularly due to iron content.
Alternative Therapies
- Individual vitamin/mineral supplements (e.g., separate folic acid, iron, calcium supplements, if specific deficiencies are identified and a comprehensive prenatal is not desired or tolerated).
- Dietary modifications to increase nutrient intake (though often insufficient for key nutrients like folic acid in pregnancy).
Cost & Coverage
Average Cost:
$15 - $40 per 30-60 gummies (1-2 month supply)
Generic Available:
Yes
Insurance Coverage:
Often OTC; may be covered by Flexible Spending Accounts (FSA) or Health Savings Accounts (HSA). Some insurance plans may cover prescription prenatal vitamins.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.