Animi-3 with Vitamin D

Manufacturer
PBM Pharmaceuticals, Inc | International Vitamin Corporation
Effective date
2011-05-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:12:01

Label at a glance#

ProductAnimi-3 with Vitamin D
Active ingredientFolic Acid, Cholecalciferol, Pyridoxine Hydrochloride, Cyanocobalamin, Omega-3 Fatty Acids, Doconexent, Icosapent, Soy Sterol
Label structure15 sections

Dosage and administration

Adults – One capsule per day or as directed by a physician.

Storage and handling

Store at 20-25°C (68-77°F). See USP Controlled Room Temperature. Protect from light and moisture.

Label contents#

Full prescribing information#

Package Insert

SPL PATIENT PACKAGE INSERT SECTION

Animi-3® with Vitamin D
    Each Capsule Contains:
    Folic Acid (Vitamin B9)                              1mg
    Cholecalciferol (Vitamin D3)                       1000IU
    Pyridoxine Hydrochloride (Vitamin B6)        12.5mg
    Cyanocobalamin (Vitamin B12)                   500mcg
    Omega-3 Acids                                         500mg
    -Docosahexaenoic Acid (DHA)                    350mg
    -Eicosapentaenoic Acid (EPA)                    35mg
    Phytosterols (Plant Sterols)                        200mg

Patent Pending
Rx Only

Description

DESCRIPTION SECTION

Animi-3® with Vitamin D Capsules are intended for oral administration.
Each Capsule Contains: 1mg Vitamin B-9 (Folic Acid USP), 1000IU Vitamin D-3 (Cholecalciferol), 12.5mg Vitamin B-6 (Pyridoxine Hydrochloride, USP), 500mcg vitamin B-12 (Cyanocobalamin, USP), Pharmaceutical Grade omega-3 Fish Oil providing 500mg Omega-3 Acids; including 350mg Docosahexaenoic Acid (DHA) and 35mg Eicosapentaenoic Acid (EPA) and 200mg Plant Sterols (Phytosterols).
Also Contains: Bleached Lecithin NF, Ascorbic Acid USP, Mixed Tocopherols NF, Ascorbyl Palmitate NF and a soft shell capsule (which contains; Gelatin USP, Glycerin NF, Titanium Dioxide USP, FD and C Red #40, FD and C Yellow #6 and USP Purified Water).

Indication

INDICATIONS & USAGE SECTION

Animi-3® with Vitamin D Capsules are indicated for improving nutritional status in conditions requiring Essential Fatty Acids, Vitamin B12, Vitamin B6, Vitamin D3 and Folic Acid supplementation.

CONTRAINDICATIONS SECTION

This product is contraindicated in patients with a known hyper-sensitivity to any of the ingredients.

Warning

WARNINGS SECTION

Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anti-coagulants and in those known to have inherited or acquired bleeding diathesis.

Warning

WARNINGS SECTION

Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1.0mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

Pediatric Use

PEDIATRIC USE SECTION

Safety and effectiveness in pediatric patients have not been established.

Pregnancy and Lactation

PREGNANCY SECTION

The safety of phytosterols has not been studied in pregnant or breastfeeding women. There is no evidence that dietary intakes of naturally occurring phytosterols, such as those consumed by vegetarian women, adversely affects pregnancy or lactation.

Adverse Reactions

ADVERSE REACTIONS SECTION

Allergic sensitization has been reported following oral, enteral and parenteral administration of folic acid.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Adults – One capsule per day or as directed by a physician.

How Supplied

HOW SUPPLIED SECTION

Animi-3® with Vitamin D supplied as orange opaque oblong capsules. Each capsule in imprinted with “Animi-3D” in black opacode. Animi-3® with Vitamin D Capsules are available in bottles of 60 capsules (NDC 66213-542-60).

Keep out of reach of children.

WARNINGS AND PRECAUTIONS SECTION

Dispense in a well-closed, tight light-resistant container as defined in the USP using a child-resistant closure.

Storage Conditions:

STORAGE AND HANDLING SECTION

Store at 20-25°C (68-77°F). See USP Controlled Room Temperature. Protect from light and moisture.

SPL UNCLASSIFIED SECTION

PBM Pharmaceuticals, Inc.
Charlottesville, VA 22902
Rev. 0411
©2011 All Rights Reserved.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC  66213-542-60     60 Capsules

Animi 3D with Vitamin D

Folic Acid (Vitamin B-9)         1 mg
Cholecalciferol (Vitamin D-3)     1000 IU
Pyridoxine Hydrochloride (Vitamin B-6)     12.5 mg
Cyanocobalamin (Vitamin B-12)     500 mcg
Omega 3 Acids      500 mg
– Docosahexaenoic Acid (DHA)    350 mg
– Eicosapentaenoic Acid (EPA)    35 mg
Phytosterols (Plant Sterols)    200 mg

Rx Only

Image of labelImage of label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1193046cholecalciferol 1000 UNT / folic acid 1 MG / omega-3 acid ethyl esters (USP) 500 MG / phytosterols 200 MG / pyridoxine hydrochloride 12.5 MG / vitamin B12 0.5 MG Oral Capsule [Animi-3 with Vitamin D]SBD1
1193037cholecalciferol 1000 UNT / folic acid 1 MG / omega-3 acid ethyl esters (USP) 500 MG / phytosterols 200 MG / pyridoxine hydrochloride 12.5 MG / vitamin B12 0.5 MG Oral CapsuleSCD1
1193037cholecalciferol 1000 UNT / folate 1 MG / omega-3 acid ethyl esters (USP) 500 MG / phytosterols 200 MG / vit-B6 hydrochloride 12.5 MG / vitamin B12 0.5 MG Oral CapsuleSY1
1193046cholecalciferol 1000 UNT / folate 1 MG / omega-3 acid ethyl esters (USP) 500 MG / phytosterols 200 MG / vit-B6 hydrochloride 12.5 MG / vitamin B12 0.5 MG Oral Capsule [Animi-3 with Vitamin D]SY1
1193037cholecalciferol 1000 UNT / folate 1 MG / omega-3 acid ethyl esters (USP) 500 MG / phytosterols 200 MG / vitamin B6 hydrochloride 12.5 MG / vitamin B12 0.5 MG Oral CapsuleSY1
1193046cholecalciferol 1000 UNT / folate 1 MG / omega-3 acid ethyl esters (USP) 500 MG / phytosterols 200 MG / vitamin B6 hydrochloride 12.5 MG / vitamin B12 0.5 MG Oral Capsule [Animi-3 with Vitamin D]SY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
OMEGA-3 FATTY ACIDS Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f6766515-27b8-72de-2010-167151236aceProduct name720251021
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66213-542-602020-01-31C16284748780-19d75b9d0-4abc-f424-e053-dadaa90a57ceAnimi-3 with Vitamin D

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66213-542-60Animi-3 with Vitamin D60 in 1 BOTTLE, PLASTICCAPSULE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66213-542ANIMI-3 WITH VITAMIN D (FOLIC ACID, CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT) CAPSULE [PBM PHARMACEUTICALS, INC]1Legacy NDC, 1 package rows20110601_d77846ab-bce6-4646-8c09-ddfcf09898a3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66213-542-60EA - Each66213-5421186a075-c88f-4859-9ab9-ed8d9daf3a9f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CholecalciferolACTIVE INGREDIENT1C6V77QF411
CyanocobalaminACTIVE INGREDIENTP6YC3EG2041
DoconexentACTIVE INGREDIENTZAD9OKH9JC1
Folic AcidACTIVE INGREDIENT935E97BOY81
IcosapentACTIVE INGREDIENTAAN7QOV9EA1
Omega-3 Fatty AcidsACTIVE INGREDIENT71M78END5S1
Pyridoxine HydrochlorideACTIVE INGREDIENT68Y4CF58BV1
Soy SterolACTIVE INGREDIENTPL360EPO9J1
CholecalciferolACTIVE MOIETY1C6V77QF411
CyanocobalaminACTIVE MOIETYP6YC3EG2041
DoconexentACTIVE MOIETYZAD9OKH9JC1
Folic AcidACTIVE MOIETY935E97BOY81
IcosapentACTIVE MOIETYAAN7QOV9EA1
Omega-3 Fatty AcidsACTIVE MOIETY71M78END5S1
PyridoxineACTIVE MOIETYKV2JZ1BI6Z1
Soy SterolACTIVE MOIETYPL360EPO9J1
Alpha-TocopherolINACTIVE INGREDIENTH4N855PNZ11
Ascorbic AcidINACTIVE INGREDIENTPQ6CK8PD0R1
Ascorbyl PalmitateINACTIVE INGREDIENTQN83US2B0N1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOA1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A81
GelatinINACTIVE INGREDIENT2G86QN327L1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Lecithin, SoybeanINACTIVE INGREDIENT1DI56QDM621
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JP1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66213-54266213-542-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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 5 · 269 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RSOLUTION / ORAL600 mgExact identifier — unii candidate
25 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8DROPS / ORAL0.2 mg/1mlExact identifier — unii candidate
34 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8POWDER, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
Lecithin, SoybeanSOYBEAN LECITHIN1DI56QDM62TABLET, FILM COATED / ORAL0.33 mgExact identifier — unii candidate
7 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii candidate
40 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii candidate
28 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RSOLUTION / TOPICAL0.04 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
GelatinGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR14 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / RECTAL0.5 %w/vExact identifier — unii candidate
34 equally ranked IID candidates
Ascorbyl PalmitateASCORBYL PALMITATEQN83US2B0NSUPPOSITORY / RECTAL16 mgExact identifier — unii candidate
6 equally ranked IID candidates
GelatinGELATIN2G86QN327LCAPSULE, DELAYED RELEASE / ORAL1791 mgExact identifier — unii candidate
44 equally ranked IID candidates
GelatinGELATIN2G86QN327LINJECTION / INTRAVENOUS20 mgExact identifier — unii candidate
44 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii candidate
40 equally ranked IID candidates
GelatinGELATIN2G86QN327LTABLET, ORALLY DISINTEGRATING / ORAL120 mgExact identifier — unii candidate
44 equally ranked IID candidates
GelatinGELATIN2G86QN327LINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
44 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY / VAGINALNAExact identifier — unii candidate
40 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RTABLET, ORALLY DISINTEGRATING / ORAL2.35 mgExact identifier — unii candidate
25 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RSOLUTION / RESPIRATORY (INHALATION)0.04 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8SUSPENSION, EXTENDED RELEASE / ORAL0.12 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
GelatinGELATIN2G86QN327LCAPSULE, LIQUID FILLED / ORAL1042 mgExact identifier — unii candidate
44 equally ranked IID candidates
GelatinGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOAGUM, CHEWING / BUCCAL48 mgExact identifier — unii candidate
28 equally ranked IID candidates
GelatinGELATIN2G86QN327LPASTILLE / ORAL143 mgExact identifier — unii candidate
44 equally ranked IID candidates
GelatinGELATIN2G86QN327LELIXIR / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1440 mgExact identifier — unii candidate
25 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOATABLET / BUCCAL0.01 mgExact identifier — unii candidate
28 equally ranked IID candidates
Lecithin, SoybeanSOYBEAN LECITHIN1DI56QDM62AEROSOL, METERED / RESPIRATORY (INHALATION)0.1 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
Lecithin, SoybeanSOYBEAN LECITHIN1DI56QDM62POWDER, FOR SUSPENSION / ORAL39 mgExact identifier — unii candidate
7 equally ranked IID candidates
GelatinGELATIN2G86QN327LINJECTION / INTRAMUSCULAR16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RINJECTION, SOLUTION / INTRAVENOUS4 mgExact identifier — unii candidate
25 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / BUCCAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii candidate
28 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8POWDER, FOR SOLUTION / ORAL40 mgExact identifier — unii candidate
34 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii candidate
40 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPFILM / BUCCAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RINJECTION / INTRAVENOUS1440 mgExact identifier — unii candidate
25 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii candidate
34 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RINJECTION / INTRACAVITARY5 mgExact identifier — unii candidate
25 equally ranked IID candidates
Lecithin, SoybeanSOYBEAN LECITHIN1DI56QDM62CAPSULE / ORAL20 mgExact identifier — unii candidate
7 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / BUCCAL1 mgExact identifier — unii candidate
34 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RSUSPENSION, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
25 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED / ORAL17 mgExact identifier — unii candidate
40 equally ranked IID candidates
Alpha-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOATABLET / ORAL7 mgExact identifier — unii candidate
28 equally ranked IID candidates
GelatinGELATIN2G86QN327LCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
44 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPSUSPENSION / ORAL113 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, COATED / ORAL3.17 mgExact identifier — unii candidate
34 equally ranked IID candidates
GelatinGELATIN2G86QN327LINJECTION / SUBCUTANEOUS16 %w/vExact identifier — unii candidate
44 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
b4abec8b-4e5a-4374-bb05-bebd71523c96d77846ab-bce6-4646-8c09-ddfcf09898a32011-05-23Warnings, Adverse reactionsExact identifier
spl id: b4abec8b-4e5a-4374-bb05-bebd71523c96
spl set id: d77846ab-bce6-4646-8c09-ddfcf09898a3

Reported adverse events (FAERS/openFDA)#

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