Home › NDC Lookup › Ingredients › Prenatal Supplement With Dha › 00642-0070-03
Vitafol One Prenatal Supplement with DHA 330 ug; 30 mg; 1.6 mg; 1.8 mg; 15 mg; 2.5 mg; .012 mg; 1700 ug; .15 mg; 20 mg; 25 mg; 2 mg Capsule, Gelatin Coated, 3-count — NDC 00642-0070-03 package photo

Vitafol One Prenatal Supplement with DHA 330 ug; 30 mg; 1.6 mg; 1.8 mg; 15 mg; 2.5 mg; .012 mg; 1700 ug; .15 mg; 20 mg; 25 mg; 2 mg Capsule, Gelatin Coated, 3-count

by Exeltis USA, Inc. · 1 BLISTER PACK in 1 BOX (0642-0070-03) / 3 CAPSULE, GELATIN COATED in 1 BLISTER PACK
NDC 00642-0070-03
🏷️ FDA NDC (as labeled) 0642-0070-03 billing pads the labeler segment with a zero
This package
Contains3-count Pack sizes2 compare ↓
Also comes in: 6 capsules 00642-0070-30
Rx only On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 0642-0070-03
Product NDC 0642-0070
11-digit billing NDC 00642007003
RxCUI 1119569, 1119573
UNII 81G40H8B0T, PQ6CK8PD0R, 8K0I04919X, TLM2976OFR, 2679MF687A, 68Y4CF58BV +10 more
UPC 0306420070303
SPL Set ID 42a5cafd-a2c0-4ac2-99c9-708642f00716
Established class (EPC) Vitamin A; Vitamin C; Nicotinic Acid; Vitamin B12; Copper-containing Intrauterine Device; Omega-3 Fatty Acid
Physiologic effect Decreased Embryonic Implantation; Decreased Sperm Motility; Inhibit Ovum Fertilization
Chemical class Vitamin A; Ascorbic Acid; Nicotinic Acids; Vitamin B 12; Copper; Fatty Acids, Omega-3
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-06-13
Route ORAL
Dosage form CAPSULE, GELATIN COATED
Substance VITAMIN A; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; FOLIC ACID; IODINE; MAGNESIUM; ZINC; COPPER; VITAMIN D; OMEGA-3 FATTY ACIDS; .ALPHA.-TOCOPHEROL; IRON
GPI-14 78516032000130
GPI class Vitafol-One
GCN Seq No 067479
GCN 30046
HICL code 037680
Ingredient (HICL) Prenatal 26/Iron Ps/Folic/Dha
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C6
Therapeutic class — intermediate (HIC2) Vitamins
HIC3 code C6F
Therapeutic class — specific (HIC3) Prenatal Vitamin Preparations
AHFS code 20:04.04.00
AHFS class Iron Preparations
FDB label name VITAFOL-ONE CAPSULE
FDB brand name Vitafol-One
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Why two NDCs? The FDA registers this code as 0642-0070-03 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00642-0070-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Vitamin B1, plain class.

Drug family (ATC) Vitamin B1, plain
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerExeltis USA, Inc.
Labeler code00642
First marketedJun 2011
Product typeHuman Prescription Drug
Portfolio10 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name VITAFOL-ONE CAPSULE Ingredient Prenatal 26/Iron Ps/Folic/Dha
📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Multivitamin products are used to provide essential vitamins recommended for the daily diet. Multivitamins are in a class of medications called vitamins. It works by providing vitamins that are essential to a well-balanced diet.

Read the full MedlinePlus article ↗
🧪 What is this product?

Vitafol One is a gelatin-coated capsule taken by mouth that contains a combination of vitamins, minerals, and omega-3 fatty acids. The product includes B vitamins (thiamine, riboflavin, niacin, B6, and B12), vitamin A, vitamin C, vitamin D, vitamin E, folic acid, iron, zinc, copper, magnesium, iodine, and omega-3 fatty acids from fish oil. These ingredients are commonly included in prenatal supplements and are typically used to support nutritional needs during pregnancy. This product is marketed without an FDA-approved application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color blue
ShapeOval
ImprintEV0070
Size1 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII YC9ST449YJ
    Ethyl vanillin is a synthetic vanilla flavoring compound. It's added to medicines to mask bitter or unpleasant tastes, making them easier to take.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 241ATL177A
    Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

13 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 6 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vitafol One 330 ug/1; 30 mg/1; 1.6 mg/1; 1.8 mg/1; 15 mg/1; 2.5 mg/1; .012 mg/1; 1700 ug/1; .15 mg/1; 20 mg/1; 25 mg/1; 2 mgthis 00642-0070-03 Exeltis 3 capsules — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2011
On the market since
Jun 2011
📍
2026
Currently FDA-listed
15 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
6 capsules00642-0070-30 21,326 Rx · $3,877,667
3 capsules this page00642-0070-03 No Medicaid data
Drug total (last 4 qtrs): 21,326 Rx · 877,546 units · $3,877,667 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Vitafol-One — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Vitafol-One. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2K
Claims incl. refills
11
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$185.85
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Vitafol One (this brand).

Top reported reactions

Premature Delivery12
Premature Labour4
Covid-193
Nasopharyngitis3
Nausea3
Anaemia Of Pregnancy2
Diarrhoea2

Age at onset

Adult3

Reporter sex

44 reports
Female · 100%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 8 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00642-0070-03 You're viewing this 1 BLISTER PACK in 1 BOX (0642-0070-03) / 3 CAPSULE, GELATIN COATED in 1 BLISTER PACK — — 2018-10-01 Active
00642-0070-30 5 BLISTER PACK in 1 BOX (0642-0070-30) / 6 CAPSULE, GELATIN COATED in 1 BLISTER PACK $4.48 / ea $134.47 2011-06-13 Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 00642-0070-03?
NDC 00642-0070-03 is a 3-count package — 1 blister pack in 1 box / 3 capsule, gelatin coated in 1 blister pack.
What NDC number is used to bill for this package of Vitafol One Prenatal Supplement with DHA 330 ug; 30 mg; 1.6 mg; 1.8 mg; 15 mg; 2.5 mg; .012 mg; 1700 ug; .15 mg; 20 mg; 25 mg; 2 mg Capsule, Gelatin Coated?
Bill NDC 00642-0070-03 — the 11-digit billing format is 00642007003. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0642-0070-03, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00642-0070-03, written without dashes as 00642007003. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00642-0070-03, the first segment (00642) is the labeler code FDA assigned to Exeltis USA, Inc.; the middle segment (0070) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Exeltis USA, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 6 capsules (00642-0070-30). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Exeltis USA, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🧒 Pediatric Use 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning 39 words ▾

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 a Poison Control Center immediately.

🎯 Indications and Usage 38 words ▾

USAGE: Vitafol ® One is indicated to provide vitamin, mineral, and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother, including individuals with known allergies to fish.*

⏱️ Dosage and Administration 21 words ▾

DOSAGE AND ADMINISTRATION: Before, during and after pregnancy, take one softgel capsule by mouth daily, or as directed by a physician.

⛔ Contraindications 101 words ▾

CONTRAINDICATIONS: Vitafol ® One is contraindicated in patients with hypersensitivity to any of its components or color additives. Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.

Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B-12).

⚠️ Warnings ~2 min read ▾

WARNINGS/PRECAUTIONS: Vitafol ® One should be used with caution in patients with known sensitivity or allergy to soy. Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues.

Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur. Iodine should be used with caution in patients with an overactive thyroid. Prolonged use of iron salts may produce iron storage disease.

Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive. The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency. Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding.

Supplemental intake of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recommended. Avoid Overdosage. Keep out of the reach of children.

Drug Interactions: Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism. Medications for hypertension used in conjunction with iodine supplementation may increase potassium. High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol, valproic acid.

Folic acid may decrease a patient's response to methotrexate. Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. Zinc can inhibit the absorption of certain antibiotics; taken at least 2 hours apart to minimize interactions.

Consult appropriate references for additional specific vitamin drug interactions. Information for Patients: Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding. Pediatric Use: Not recommended for pediatric use.

🤒 Adverse Reactions 71 words ▾

ADVERSE REACTIONS: Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol ® One. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.

You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact 1-877-324-9349.

🔄 Drug Interactions 120 words ▾

Drug Interactions: Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism. Medications for hypertension used in conjunction with iodine supplementation may increase potassium. High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol, valproic acid.

Folic acid may decrease a patient's response to methotrexate. Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. Zinc can inhibit the absorption of certain antibiotics; taken at least 2 hours apart to minimize interactions.

Consult appropriate references for additional specific vitamin drug interactions.

🧒 Pediatric Use 7 words ▾

Pediatric Use: Not recommended for pediatric use.

📦 How Supplied / Storage and Handling 53 words ▾

HOW SUPPLIED: Vitafol ® One is available as dark a blue, oval shaped softgel capsule imprinted “EV0070”. Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 softgel capsules), (0642-0070-30) and as professional samples (0642-0070-03). Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat, light and moisture.

📦 Storage and Handling 13 words ▾

Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat, light and moisture.

📋 Description 144 words ▾

COMPOSITION: Each Softgel Capsule Contains: VITAMINS AND MINERALS: Vitamin A (as beta carotene) 330 mcg RAE Vitamin C (as ascorbic acid) 30 mg Vitamin D (as cholecalciferol) 25 mcg Vitamin E (as dl-alpha tocopheryl acetate) 9 mg Thiamin (Vitamin B1 as thiamine mononitrate) 1.6 mg Riboflavin (Vitamin B2) 1.8 mg Niacin (as niacinamide) 15 mg NE Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg Folate (as folic acid) 1700 mcg DFE Vitamin B12 (as cyanocobalamin) 12 mcg Iron (as polysaccharide iron complex) 29 mg Iodine (as potassium iodide) 150 mcg Magnesium (as magnesium oxide) 20 mg Zinc (as zinc oxide) 25 mg Copper (as copper oxide) 2 mg Docosahexaenoic acid (DHA) (from natural algal oil) 200 mg Other Ingredients: Gelatin (Bovine), Glycerin, Soybean Oil, Yellow Beeswax, Sorbitol, Purified Water, Soy Lecithin, Sunflower Oil, Microcrystalline Cellulose, FD&C Blue #1, Ethyl Vanillin, Mannitol, Titanium Dioxide.

Contains: Soy.

💬 Information for Patients 23 words ▾

Information for Patients: Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00641-9219-10 · Hikma 00642-0075-30 · Exeltis →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.