Home › NDC Lookup › Ingredients › Asorbic Acid, Vitamin A Palmitate, Chole... › 60505-6171-00
📦image loading
(from DailyMed)

Multiple Vitamins (Pediatric) Pharmacy Bulk Package Asorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin Kit

by Apotex Corp · 1 KIT in 1 CARTON (60505-6171-0) * 40 mL in 1 VIAL (60505-6295-1) * 10 mL in 1 VIAL (60505-6296-2)
NDC 60505-6171-00
🏷️ FDA NDC (as labeled) 60505-6171-0 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 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) 60505-6171-0
Product NDC 60505-6171
11-digit billing NDC 60505617100
NCPDP billing unit ML — per mL (volume)
Application # ANDA210456
SPL Set ID d9b6eb9a-4218-5c94-6e35-7cbbf0fba494
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-01
Route INTRAVENOUS
Dosage form KIT
GCN Seq No 058198
GCN 23555
HICL code 026696
Ingredient (HICL) Multivit Infusion,Pedi 1,Vit K
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C6
Therapeutic class — intermediate (HIC2) Vitamins
HIC3 code C6H
Therapeutic class — specific (HIC3) Pediatric Vitamin Preparations
AHFS code 88:28.00.00
AHFS class Multivitamin Preparations
FDB label name MULTIPLE VIT INJ PEDI BULK VL
FDB brand name Multiple Vitamins Inject Pedi
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 60505-6171-0 — a 5-4-1 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 package segment → 60505-6171-00. 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.

🏭 Manufacturer & labeler

LabelerApotex Corp
Application holderAPOTEX INC
FDA applicationANDA210456 (ANDA)
Labeler code60505
First marketedJul 2026
Product typeHuman Prescription Drug
Portfolio53 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 MULTIPLE VIT INJ PEDI BULK VL Ingredient Multivit Infusion,Pedi 1,Vit K

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.

🧪 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.
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
Multiple Vitamins (Pediatric) Pharmacy Bulk Packagethis 60505-6171-00 Apotex 1 kit — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🔬 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 Multiple Vitamins (Pediatric) Pharmacy Bulk Package (this brand).

Top reported reactions

Unresponsive To Stimuli1

Reporter sex

1 reports

Serious outcomes

Life-threatening1
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 Marketing startStatus
60505-6171-00 You're viewing this 1 KIT in 1 CARTON (60505-6171-0) * 40 mL in 1 VIAL (60505-6295-1) * 10 mL in 1 VIAL (60505-6296-2) 2026-07-01 Active

🧭 About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 ✓ Available
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

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 60505-6171-0, 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: 60505-6171-00, written without dashes as 60505617100. 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 60505-6171-00, the first segment (60505) is the labeler code FDA assigned to Apotex Corp; the middle segment (6171) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 Apotex Corp. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Apotex Corp 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.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 80 words ▾

1 INDICATIONS AND USAGE Multiple vitamins injection (pediatric) is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition. The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy. Multiple vitamins injection (pediatric) is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Multiple vitamins injection (pediatric) is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K 1 , folic acid, biotin, and vitamin B 12 ( 2.1 ) Multiple vitamins injection (pediatric) is for administration by intravenous infusion after dilution ( 2.1 ) Recommended daily dosage is based on patient’s actual weight ( 2.2 ): Multiple vitamins injection (pediatric) Pharmacy Bulk Package: Weight less than 1 kg: 1.5 mL of combined content of Vials 1 and 2 Weight 1 kg to less than 3 kg: 3.25 mL of combined content of Vials 1 and 2 Weight 3 kg or greater: 5 mL of combined content of Vials 1 and 2.

Supplemental vitamin A may be required for low-birth weight infants ( 2.2 ) Multiple vitamins injection (pediatric) is supplied as a pharmacy bulk package: Pharmacy Bulk Package consists of two vials labeled Vial 1 and Vial 2. Transfer contents of Vial 2 to contents of Vial 1. Then, take 1.5 mL, 3.25 mL, or 5 mL from mixture and add to at least 100 mL of intravenous dextrose or saline solution prior to intravenous use ( 2.3 ) After dilution in an intravenous infusion, refrigerate resulting solution unless used immediately.

Use solution within 24 hours after dilution ( 2.3 ) Monitor blood vitamin concentrations ( 2.4 ) See Full Prescribing Information for drug incompatibilities ( 2.5 )

2.1Important Dosage and Administration Instructions Multiple vitamins injection (pediatric) is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K 1 , folic acid, biotin, and vitamin B 12 . Multiple vitamins injection (pediatric) is supplied as a pharmacy bulk package for intravenous use intended for administration by intravenous infusion after dilution: Multiple vitamins injection (pediatric) Pharmacy Bulk Package consists of two pharmacy bulk vials which must be mixed prior to use.

The mixed solution will provide multiple daily doses which must be diluted prior to intravenous administration. Pharmacy bulk package of multiple vitamins injection (pediatric) is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion. [see Dosage and Administration ( 2.2 and 2.3 )].

2.2Dosage Information The recommended daily dosage volume is based on the patient's actual weight: less than 1 kg, 1 kg to less than 3 kg, and 3 kg or greater. Patients with multiple vitamin deficiencies or with increased vitamin requirements may need multiple daily dosages as indicated or additional doses of individual vitamins. Supplemental vitamin A may be required for low-birth weight infants.

Additional daily dosages of Vitamin E in infants are not recommended [see Warnings and Precautions ( 5.8 )] . Multiple vitamins injection (pediatric) Pharmacy Bulk Package (see Table 2 ): The recommended daily dosage volume of combined content of vials 1 and 2 (1.5 mL, 3.25 mL or 5 mL) is based on the patient’s weight and then added directly to the specific volume of an intravenous fluid [ see Dosage and Administration ( 2.3 ) ] . Table 2: Recommended Weight-Based Dosage of Multiple Vitamins Injection (Pediatric) Pharmacy Bulk Package Less than 1 kg 1 kg to less than 3 kg 3 kg or greater Daily Dosage Volume (combined contents of Vial 1 and Vial 2) 1.5 mL 3.25 mL 5 mL Ascorbic acid (Vitamin C) 24 mg 52 mg 80 mg Vitamin A (as palmitate) 690 IU (equals 0.2 mg) 1,495 IU (equals 0.5 mg) 2,300 IU (equals 0.7 mg) Vitamin D 3 (cholecalciferol) 120 IU (equals 3 mcg) 260 IU (equals 7 mcg ) 400 IU (equals 10 mcg) Thiamine (Vitamin B 1 ) (as the hydrochloride) 0.4 mg 0.8 mg 1.2 mg Riboflavin (Vitamin B 2 ) (as riboflavin 5-phosphate sodium) 0.4 mg 0.9 mg 1.4 mg Pyridoxine HCl (Vitamin B 6 ) 0.3 mg 0.7 mg 1 mg Niacinamide 5.1 mg 11.1 mg 17 mg D…

💊 Dosage Forms and Strengths 178 words ▾

3 DOSAGE FORMS AND STRENGTHS Multiple vitamins injection (pediatric) Pharmacy Bulk Package is an injection consisting of two vials labeled Vial 1 (40 mL Fill in 50 mL Vial) and Vial 2 (10 mL). The mixed solution (50 mL) will provide thirty-three 1.5 mL single doses, fifteen 3.25 mL single doses or ten 5 mL single doses. For the vitamin strengths [see Dosage and Administration (2.2) and Description ( 11 )].

Vial 1 (Pharmacy Bulk Package) is supplied as clear, yellow to orange colored solution in amber glass vial, closed with a rubber stopper, aluminum flip-off seal of a blue color matte top. Vial 2 (Pharmacy Bulk Package) is supplied as clear, off white to pale yellow colored solution in amber glass vial, closed with a rubber stopper, aluminum flip-off seal of a pink color matte top. Multiple vitamins injection (pediatric) pharmacy bulk package is an injection consisting of two vials labeled Vial 1 (40 mL fill in 50 mL) and Vial 2 (10 mL) ( 3 ) See Full Prescribing Information for vitamin strengths ( 11 )

⛔ Contraindications 48 words ▾

4 CONTRAINDICATIONS Multiple vitamins injection (pediatric) is contraindicated in patients who have: • An existing hypervitaminosis, or • A history of hypersensitivity to any vitamins or excipients contained in this formulation. • Hypersensitivity to any of vitamins or excipients ( 4 ) • Existing hypervitaminosis ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Risk of Aluminum Toxicity: For at risk patients (renal failure or those with prolonged therapy), consider periodic monitoring of aluminum levels ( 5.1 ) • Allergic Reactions: To thiamine may occur ( 5.2 ) • Hypervitaminosis A : Patients with renal failure or liver disease may be at higher risk ( 5.3 ) • Decreased Anticoagulant Effect of Warfarin: Monitor INR ( 5.4 , 7.1 ) • Interferes with Megaloblastic Anemia Diagnosis: Avoid during testing for this disorder ( 5.5 ) • Risk of Vitamin Deficiencies or Excesses: Monitor blood vitamin concentrations ( 5.6 ) • False Negative Urine Glucose Tests: Due to vitamin C ( 5.7 ) • Risk of Vitamin E Toxicity: Additional oral and parenteral vitamin E may result in elevated vitamin E blood concentrations in infants ( 5.8 ) • Low Vitamin A Levels: Monitor vitamin A levels ( 5.9 ) • Risk of E- Ferol Syndrome: Due to polysorbates ( 5.10 )

5.1Aluminum Toxicity Multiple vitamins injection (pediatric) contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration in pediatric patients with renal impairment. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solution, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. To prevent aluminum toxicity periodically monitor aluminum levels with prolonged parenteral administration of multiple vitamins injection (pediatric).

5.2Allergic Reactions to Thiamine Allergic reactions such as urticaria, shortness of breath, wheezing and angioedema have been reported following intravenous administration of thiamine, which is found in multiple vitamins injection (pediatric). There have been rare reports of anaphylaxis following intravenous doses of thiamine. No fatal anaphylaxis associated with multiple vitamins injection (pediatric) has been reported.

5.3Hypervitaminosis A Hypervitaminosis A, manifested by nausea, vomiting, headache, dizziness, blurred vision has been reported in patients with renal failure receiving 1.5 mg/day retinol and in patients with liver disease. Therefore, supplementation of renal failure patients and patients with liver disease with vitamin A, an ingredient found in multiple vitamins injection (pediatric), should be undertaken with caution [ see Use in Specific Populations ( 8.6 and 8.7 ) ]. Blood levels of Vitamin A should be monitored periodically.

5.4Decreased Anticoagulant Effect of Warfarin Multiple vitamins injection (pediatric) contains Vitamin K which may decrease the anticoagulant action of warfarin. In patients who are on warfarin anticoagulant therapy receiving multiple vitamins injection (pediatric) monitor blood levels of prothrombin/INR to determine if dose of warfarin needs to be adjusted.

5.5Interference with Diagnosis of Megaloblastic Anemia Multiple vitamins injection (pediatric) contains folic acid and cyanocobalamin which can mask serum deficiencies of folic acid and cyanocobalamin in patients with megaloblastic anemia. Avoid the use of multiple vitamins injection (pediatric) in patients with suspected or diagnosed megaloblastic anemia prior to blood sampling for the detection of the folic acid and cyanocobalamin deficiencies.

5.6Potential to Develop Vitamin Deficiencies or Excesses In patients receiving parenteral multivitamins such as with multiple vitamins injection (pediatric), blood vitamin concentrations should be periodically monitored to determine if vitamin deficiencies or excesses are developing. Multiple vitamins injection (pediatric) may not correct long-standing specific vitamin deficiencies. The administration of additional doses of specific vitamins may…

🤒 Adverse Reactions 132 words ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling. • Allergic reactions to thiamine [ see Warnings and Precautions ( 5.2 ) ]. • Hypervitaminosis A [ see Warnings and Precautions ( 5.3 ) ] The following adverse reactions have been identified during postapproval use of multiple vitamins injection (pediatric). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Dermatologic: rash, erythema, pruritis CNS: headache, dizziness, agitation, anxiety Ophthalmic: diplopia Adverse reactions have included anaphylaxis, rash, erythema, pruritis, headache, dizziness, agitation, anxiety, diplopia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS A number of interactions between vitamins and drugs have been reported. The following are examples of these types of interactions. Effect of multiple vitamins injection (pediatric) on other drugs : • Antibiotics: Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid decrease activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin ( 7.1 ) • Bleomycin : Ascorbic acid and riboflavin may reduce the activity of bleomycin ( 7.1 ) • Levodopa: Pyridoxine may decrease blood levels of levodopa and levodopa efficacy may decrease ( 7.1 ) • Phenytoin: Folic acid may decrease phenytoin blood levels and increase risk of seizure activity ( 7.1 ) • Methotrexate: Folic acid may decrease response to methotrexate ( 7.1 ) Effects of other drugs on multiple vitamins injection (pediatric) : • Hydralazine, Isoniazid: Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements ( 7.2 ). • Phenytoin: May decrease folic acid concentrations ( 7.2 )

7.1Drug Interactions Affecting Co-Administered Drugs Warfarin: Vitamin K, a component of multiple vitamins injection (pediatric), antagonizes the anticoagulant action of warfarin. In patients who are co-administered warfarin and multiple vitamins injection (pediatric), blood levels of prothrombin/INR should be monitored to determine if dose of warfarin needs to be adjusted [see Warnings and Precautions ( 5.4 )] . Antibiotics: Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid decrease antibiotic activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin.

Bleomycin: Ascorbic acid and riboflavin inactivate bleomycin in vitro , thus the activity of bleomycin may be reduced. Levodopa: Pyridoxine may increase the metabolism of levodopa (decrease blood levels of levodopa) and decrease its efficacy. Phenytoin: Folic acid may increase phenytoin metabolism and lower the serum concentration of phenytoin resulting in increased seizure activity.

Methotrexate: Folic acid may decrease a patient’s response to methotrexate therapy.

7.2Drug Interactions Affecting Vitamin Levels Hydralazine, Isoniazid: Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements. Phenytoin: Phenytoin may decrease serum folic acid concentrations.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy and Lactation: Pregnant and lactating patients should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonpregnant and nonlactating patients ( 8.1 , 8.2 ) Renal Impairment: Monitor renal function, calcium, phosphorus and vitamin A levels ( 8.6 ) Hepatic Impairment: Monitor vitamin A levels ( 8.7 )

8.1Pregnancy Risk Summary Administration of the approved recommended dose of multiple vitamins injection (pediatric) in parental nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Pregnant patients should follow the U.S. Recommended Daily Allowances for pregnancy because their vitamin requirements may exceed those of nonpregnant patients.

Deficiency of essential vitamins may result in adverse pregnancy outcomes (see Clinical Considerations) . Animal reproduction studies have not been conducted with multiple vitamins injection (pediatric). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo-Fetal Risk Deficiency of essential vitamins has been associated with adverse pregnancy and fetal outcomes, such as maternal folic acid deficiency and an increased risk of neural tube defects.

Therefore, parenteral nutrition with multiple vitamins injection should be considered if a pregnant patient’s nutritional requirements cannot be fulfilled by oral or enteral intake.

8.2Lactation Risk Summary Multiple vitamins present in multiple vitamins injection (pediatric) are also present in human milk. Administration of the approved recommended dose of multiple vitamins injection (pediatric) in parental nutrition is not expected to cause harm to a breastfed infant. There is no information on the effects of multiple vitamins injection (pediatric) on milk production.

Lactating patients should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonlactating patients. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for multiple vitamins injection (pediatric) and any potential adverse effects on the breastfed child from multiple vitamins injection (pediatric) or from the underlying maternal condition.

8.4Pediatric Use Multiple vitamins injection (pediatric) is approved for the prevention of vitamin deficiency in pediatric patients up to 11 years old receiving parenteral nutrition. Multiple vitamins injection (pediatric) has not been studied in pediatric patients older than 11 years. Multiple vitamins injection (pediatric) contains aluminum that may be toxic for premature neonates.

Aluminum levels should be monitored periodically during administration of multiple vitamins injection (pediatric) to premature neonates [ see Warnings and Precautions ( 5.1 ) ]. Additional vitamin E supplementations of infants receiving multiple vitamins injection (pediatric) may result in elevated blood concentrations of vitamin E and potential vitamin E toxicity [ see Warnings and Precautions ( 5.8 ) ]. E-Ferol syndrome has been reported in low-birth weight infants following administration of polysorbates which are found in multiple vitamins injection (pediatric).

No E-Ferol syndrome associated with multiple vitamins injection (pediatric) has been reported [ see Warnings and Precautions ( 5.10 ) ].

8.6Renal Impairment Multiple vitamins injection (pediatric) has not been studied in patients with renal impairment. Monitor renal function, calcium, phosphorus and vitamin A levels in patients with ren…

🤰 Pregnancy 196 words ▾

8.1Pregnancy Risk Summary Administration of the approved recommended dose of multiple vitamins injection (pediatric) in parental nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Pregnant patients should follow the U.S. Recommended Daily Allowances for pregnancy because their vitamin requirements may exceed those of nonpregnant patients.

Deficiency of essential vitamins may result in adverse pregnancy outcomes (see Clinical Considerations) . Animal reproduction studies have not been conducted with multiple vitamins injection (pediatric). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo-Fetal Risk Deficiency of essential vitamins has been associated with adverse pregnancy and fetal outcomes, such as maternal folic acid deficiency and an increased risk of neural tube defects.

Therefore, parenteral nutrition with multiple vitamins injection should be considered if a pregnant patient’s nutritional requirements cannot be fulfilled by oral or enteral intake.

🧒 Pediatric Use 155 words ▾

8.4Pediatric Use Multiple vitamins injection (pediatric) is approved for the prevention of vitamin deficiency in pediatric patients up to 11 years old receiving parenteral nutrition. Multiple vitamins injection (pediatric) has not been studied in pediatric patients older than 11 years. Multiple vitamins injection (pediatric) contains aluminum that may be toxic for premature neonates.

Aluminum levels should be monitored periodically during administration of multiple vitamins injection (pediatric) to premature neonates [ see Warnings and Precautions ( 5.1 ) ]. Additional vitamin E supplementations of infants receiving multiple vitamins injection (pediatric) may result in elevated blood concentrations of vitamin E and potential vitamin E toxicity [ see Warnings and Precautions ( 5.8 ) ]. E-Ferol syndrome has been reported in low-birth weight infants following administration of polysorbates which are found in multiple vitamins injection (pediatric).

No E-Ferol syndrome associated with multiple vitamins injection (pediatric) has been reported [ see Warnings and Precautions ( 5.10 ) ].

🆘 Overdosage 32 words ▾

10 OVERDOSAGE Signs and symptoms of acute or chronic overdosage may be those of individual multiple vitamins injection (pediatric) component toxicity. There is no clinical experience with multiple vitamins injection (pediatric) overdosage.

📦 How Supplied / Storage and Handling 178 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Multiple vitamins injection (pediatric) is supplied as follows: Vial 1 (Pharmacy Bulk Package) is supplied as clear, yellow to orange colored solution in amber glass vial, closed with a rubber stopper, aluminum flip-off seal of a blue color matte top. Vial 2 (Pharmacy Bulk Package) is supplied as clear, off white to pale yellow colored solution in amber glass vial closed with a rubber stopper, aluminum flip-off seal of a pink color matte top. Multiple vitamins injection (pediatric) Pharmacy Bulk Package : Carton contains total two vials NDA 60505-6171-0 One vial 1 (40 mL Fill in 50 mL) NDC 60505-6295-1 One vial 2 (10 mL) NDC 60505-6296-2 Mixed contents of Vial 2 with Vial 1 provide thirty-three 1.5 mL single doses, fifteen 3.25 mL single doses or 10 single 5 mL doses [see Dosage and Administration ( 2.2 and 2.3)] .

Storage and Handling: Minimize exposure of multiple vitamins injection (pediatric) to light because vitamins A, D and riboflavin are light sensitive. Store under refrigeration 2°C to 8°C (36°F to 46°F).

📋 Description ~2 min read ▾

11 DESCRIPTION Multiple vitamins injection (pediatric) is a sterile product consisting of two vials provided as a pharmacy bulk package for intravenous use intended for administration by intravenous infusion after dilution: Multiple vitamins injection (pediatric) supplied as pharmacy bulk package consists of: (a) Vial 1 (40 mL Fill in 50 mL Vial); and (b) Vial 2 (10 mL). The mixed solution will provide many single doses [see Dosage and Administration ( 2.2 )]. Each 4 mL of Vial 1 contains 10 vitamins and each 1 mL of Vial 2 contains 3 vitamins (see Table 3 ).

Table 3: Ingredients In Multiple Vitamins Injection (Pediatric) Formulation Vial 1 Active Ingredient Quantity per 4 mL Ascorbic acid (Vitamin C) 80 mg Vitamin A* (as palmitate) 2,300 IU (equals 0.7 mg) Vitamin D 3 * (cholecalciferol) 400 IU (equals 10 mcg) Thiamine (Vitamin B 1 ) (as the hydrochloride) 1.2 mg Riboflavin (Vitamin B 2 ) (as riboflavin 5-phosphate sodium) 1.4 mg Pyridoxine HCl (Vitamin B 6 ) 1 mg Niacinamide 17 mg Dexpanthenol (as d-pantothenyl alcohol) 5 mg Vitamin E* (dl-α-tocopheryl acetate) 7 IU (equals 7 mg) Vitamin K 1 * 0.2 mg *Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K.

Inactive ingredients in 4 mL of Vial 1: 50 mg polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection. Vial 2 Active Ingredient Quantity per 1 mL Folic acid 140 mcg Biotin 20 mcg Vitamin B 12 (cyanocobalamin) 1 mcg Inactive ingredients in 1 mL of Vial 2: 75 mg mannitol, citric acid and/or sodium citrate for pH adjustment and water for injection. Multiple vitamins injection (pediatric) makes available a combination of oil-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions.

The liposoluble vitamins A, D, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins. Multiple vitamins injection (pediatric) contains no more than 170 mcg/L of aluminum (combined Vials 1 and 2).

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Instruct caregiver(s) and patients (if age appropriate): To watch for signs of allergic reactions such as urticaria, shortness of breath, wheezing and angioedema since hypersensitivity reactions may occur to any of the vitamins or excipients contained in multiple vitamins injection (pediatric). To watch for and immediately report nausea, vomiting, headache, dizziness, blurred vision, especially if patients have renal impairment, as these may be signs of hypervitaminosis A. To report other adverse reactions that patients may experience such as rash, erythema, pruritus, headache, dizziness, agitation, anxiety, and diplopia.

Patients on warfarin anticoagulant therapy will be monitored periodically with blood prothrombin/ INR levels to determine if the dose of warfarin needs to be adjusted. About the significance of periodic monitoring of blood vitamin concentrations to determine if vitamin deficiencies or excesses are developing and the need to monitor renal function, calcium, phosphorus, aluminum and vitamin A levels in patients with renal impairment. That multiple vitamins injection (pediatric) should be avoided in patients with suspected or diagnosed megaloblastic anemia prior to blood sampling for the detection of the folic acid and cyanocobalamin deficiencies.

That vitamin C (ascorbic acid) contained in multiple vitamins injection (pediatric) may cause false negative urine glucose results. Manufactured by: Manufactured for: Gland Pharma Limited Apotex Corp. Hyderabad, Telangana – 500 043, India Weston, Florida ML No.

103/AP/RR/97/F/R 33326 Revised: January 2026 Rev. 4

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 60505-6169-01 · Apotex 60505-6172-00 · Apotex →
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.