PNV Prenatal Vitamin

Manufacturer
Sancilio & Company Inc
Effective date
2017-12-27
Label type
DIETARY SUPPLEMENT
Version
5
Source
full-release
Hydrated at
2026-06-01 02:48:47

Label at a glance#

ProductPNV Prenatal Vitamin
Active ingredient.Alpha.-Tocopherol Acetate, DL-, Cholecalciferol, Cyanocobalamin, Ferrous fumarate, Folic Acid, Niacinamide, Sodium Ascorbate, Ascorbic Acid, Pyridoxine Hydrochloride, Riboflavin, Thiamine Mononitrate
Label structure9 sections

Dosage and administration

One tablet daily with a meal, or as directed by a physician. Tablets should be chewed or crushed before swallowing.

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

PNV Chewable Tablets are formulated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period, for both the lactating and non-lactating mothers, and is useful for improving nutritional status prior to conception.

STATEMENT OF IDENTITY SECTION

Each fruit-flavored PNV Chewable tablet contains:

VITAMINS:
Vitamin C (as sodium ascorbate and ascorbic acid)120 mg
Vitamin D3 (as cholecalciferol)400 IU
Vitamin E (as dl-alpha tocopheryl acetate)11 IU
Vitamin B1 (as thiamin mononitrate)2 mg
Vitamin B2 (as riboflavin)3 mg
Vitamin B3 (as niacinamide)20 mg
Vitamin B6 (as pyridoxine HCL)10 mg
Vitamin Folic Acid1 mg
Vitamin B12 (as cyanocobalamin)12 mcg
MINERAL:
Iron (as ferrous fumarate)29 mg

OTHER INGREDIENTS

HEALTH CLAIM SECTION

Microcrystalline cellulose, xylitol, magnesium stearate, talc, natural fruit flavor, malic acid, sucralose, citric acid, and mixed tocopherols.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

One tablet daily with a meal, or as directed by a physician. Tablets should be chewed or crushed before swallowing.

CAUTION

PRECAUTIONS SECTION

Folic acid may partially correct the hematological damage due to vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses.

WARNING

HEALTH CLAIM SECTION

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

ADVERSE REACTIONS

HEALTH CLAIM SECTION

In some cases, allergic hypersensitivity has been reported following administration of folic acid. Mild gastrointestinal disturbances may occur with products containing ferrous fumarate (iron), but usually subside with continuation of therapy.

HOW SUPPLIED

HEALTH CLAIM SECTION

PNV Prenatal Health™ - Prenatal Vitamins are light brown to brown-speckled, fruit-flavored, round tablets debossed "SCI" on one side.

STORAGE AND HANDLING SECTION

STORE AT CONTROLLED ROOM TEMPERATURE 15°-30°C (59°-86°F).

PROTECT FROM EXCESS HEAT AND MOISTURE. Dispense in a tight, light-resistant container with child-resistant closure.

HEALTH CLAIM SECTION

This medical food product is formulated to be administered orally, under the supervision of a physician and is intended for the management of a dietary deficiency of folic acid and iron for which a distinctive nutritional requirement, based on recognized scientific principles, has been established by medical evaluation. The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health insurance and state level reimbursement programs and is not intended to denote registration or approval from the FDA.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.

Manufactured by: Sancilio & Company, Inc.,
Riviera Beach, FL 33404
(800) SCI-8711

© 2011 Sancilio & Company, Inc.

REV: 12/06/11

PRINCIPAL DISPLAY PANEL - 90 Tablets Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

44946-1041-5

PNV Prenatal Health
PNV
Prenatal Vitamins

FOLIC ACID + IRON
MULTIVITAMIN

Chewable
Tablets

Dispense under a
physician's order†

Dietary Supplement

Sugar Free

SCI
Sancilio & Company, Inc

Developing Good Science into Great Medicine

90
TABLETS

PRINCIPAL DISPLAY PANEL - 90 Tablets Bottle Label
PRINCIPAL DISPLAY PANEL - 90 Tablets Bottle Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44946-1041-5PNV Prenatal Vitamin90 in 1 BOTTLE, PLASTICTABLET, CHEWABLE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44946-1041PNV PRENATAL VITAMIN (.ALPHA.-TOCOPHEROL ACETATE, DL-, CHOLECALCIFEROL, CYANOCOBALAMIN, FERROUS FUMARATE, FOLIC ACID, NIACINAMIDE, SODIUM ASCORBATE, ASCORBIC ACID, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, AND THIAMINE MONONITRATE) TABLET, CHEWABLE [SANCILIO & COMPANY INC]51 package rows20171228_a4476a07-9ecc-4cbf-b586-3a9f4e3bc30d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44946-1041-5EA - Each44946-1041f4f44903-b9f0-4081-a096-b934391115b412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
.Alpha.-Tocopherol Acetate, DL-ACTIVE INGREDIENTWR1WPI7EW82
Ascorbic AcidACTIVE INGREDIENTPQ6CK8PD0R2
CholecalciferolACTIVE INGREDIENT1C6V77QF412
CyanocobalaminACTIVE INGREDIENTP6YC3EG2042
Ferrous fumarateACTIVE INGREDIENTR5L488RY0Q2
Folic AcidACTIVE INGREDIENT935E97BOY82
NiacinamideACTIVE INGREDIENT25X51I8RD42
Pyridoxine HydrochlorideACTIVE INGREDIENT68Y4CF58BV2
RiboflavinACTIVE INGREDIENTTLM2976OFR2
Sodium AscorbateACTIVE INGREDIENTS033EH83592
Thiamine MononitrateACTIVE INGREDIENT8K0I04919X2
.Alpha.-Tocopherol, DL-ACTIVE MOIETY7QWA1RIO012
Ascorbic AcidACTIVE MOIETYPQ6CK8PD0R2
CholecalciferolACTIVE MOIETY1C6V77QF412
CyanocobalaminACTIVE MOIETYP6YC3EG2042
Ferrous cationACTIVE MOIETYGW89581OWR2
Folic AcidACTIVE MOIETY935E97BOY82
NiacinamideACTIVE MOIETY25X51I8RD42
PyridoxineACTIVE MOIETYKV2JZ1BI6Z2
RiboflavinACTIVE MOIETYTLM2976OFR2
Thiamine IonACTIVE MOIETY4ABT0J945J2
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSL2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61U2
Magnesium stearateINACTIVE INGREDIENT70097M6I302
Malic AcidINACTIVE INGREDIENT817L1N4CKP2
SucraloseINACTIVE INGREDIENT96K6UQ3ZD42
TalcINACTIVE INGREDIENT7SEV7J4R1U2
XylitolINACTIVE INGREDIENTVCQ006KQ1E2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44946-104144946-1041-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 202 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SucraloseSUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii candidate
22 equally ranked IID candidates
Magnesium stearateMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii candidate
39 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION, CONCENTRATE / INTRAVENOUS60 mgExact identifier — unii candidate
61 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UCAPSULE, COATED / ORAL87 mgExact identifier — unii candidate
35 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, FOR SUSPENSION / ORAL278 mgExact identifier — unii candidate
28 equally ranked IID candidates
Magnesium stearateMAGNESIUM STEARATE70097M6I30LOZENGE / ORAL420 mgExact identifier — unii candidate
39 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS81 mgExact identifier — unii candidate
61 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, DELAYED RELEASE / ORAL789.6 mgExact identifier — unii candidate
28 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE / ORAL131 mgExact identifier — unii candidate
61 equally ranked IID candidates
TalcTALC7SEV7J4R1UGUM, CHEWING / BUCCALNAExact identifier — unii candidate
35 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLFILM / SUBLINGUAL11 mgExact identifier — unii candidate
61 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii candidate
22 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii candidate
35 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE PARTICLES / ORAL580 mgExact identifier — unii candidate
28 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET / SUBLINGUAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLGEL / TOPICAL3 mgExact identifier — unii candidate
61 equally ranked IID candidates
TalcTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UGRANULE / ORAL322 mgExact identifier — unii candidate
35 equally ranked IID candidates
Magnesium stearateMAGNESIUM STEARATE70097M6I30SUSPENSION / ORAL64 mgExact identifier — unii candidate
39 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UIMPLANT / INTRAVITREAL1.66 mgExact identifier — unii candidate
28 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii candidate
28 equally ranked IID candidates
Magnesium stearateMAGNESIUM STEARATE70097M6I30DROPS / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1ESOLUTION / ORAL21600 mgExact identifier — unii candidate
12 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii candidate
28 equally ranked IID candidates
Magnesium stearateMAGNESIUM STEARATE70097M6I30IMPLANT / INTRAVITREALNAExact identifier — unii candidate
39 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLSYRUP / ORAL268 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLSPRAY, METERED / NASAL1.2 mg/1mlExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLCLOTH / TOPICAL4.2 mgExact identifier — unii candidate
61 equally ranked IID candidates
Magnesium stearateMAGNESIUM STEARATE70097M6I30POWDER, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
39 equally ranked IID candidates
Magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET / BUCCAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLTABLET / ORAL197 mgExact identifier — unii candidate
61 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED, EXTENDED RELEASE / ORAL615 mgExact identifier — unii candidate
28 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRAVENOUS1152 mgExact identifier — unii candidate
61 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii candidate
22 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLTABLET / SUBLINGUAL36 mgExact identifier — unii candidate
61 equally ranked IID candidates
Malic AcidMALIC ACID817L1N4CKPPOWDER, FOR SUSPENSION / ORAL1392 mgExact identifier — unii candidate
5 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL18 mgExact identifier — unii candidate
35 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE, EXTENDED RELEASE / ORAL12 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii candidate
61 equally ranked IID candidates
Magnesium stearateMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLELIXIR / ORAL90 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / INTRAMUSCULAR25 mgExact identifier — unii candidate
61 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii candidate
35 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii candidate
22 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE / ORAL4 mgExact identifier — unii candidate
61 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UPELLET / ORAL1140 mgExact identifier — unii candidate
28 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE / ORAL1725 mgExact identifier — unii candidate
28 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / BUCCAL18 mgExact identifier — unii candidate
28 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1ETABLET, EXTENDED RELEASE / ORAL2752 mgExact identifier — unii candidate
12 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4FILM / ORAL1 mgExact identifier — unii candidate
22 equally ranked IID candidates
TalcTALC7SEV7J4R1ULOZENGE / ORAL50 mgExact identifier — unii candidate
35 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLLOTION / TOPICAL211 mgExact identifier — unii candidate
61 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii candidate
28 equally ranked IID candidates
Magnesium stearateMAGNESIUM STEARATE70097M6I30SYSTEM / INTRAVITREAL0.02 mgExact identifier — unii candidate
39 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SUSPENSION / ORAL570 mgExact identifier — unii candidate
61 equally ranked IID candidates
Magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL47 mgExact identifier — unii candidate
39 equally ranked IID candidates
Magnesium stearateMAGNESIUM STEARATE70097M6I30POWDER / TOPICAL104 mgExact identifier — unii candidate
39 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
96a85945-754b-4589-b73d-39541b44eac8a4476a07-9ecc-4cbf-b586-3a9f4e3bc30d2017-12-27Boxed warning, Adverse reactionsExact identifier
spl set id: a4476a07-9ecc-4cbf-b586-3a9f4e3bc30d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.