Dosage and administration
Adults – One capsule per day or as directed by a physician.
Adults – One capsule per day or as directed by a physician.
Store at 20-25°C (68-77°F). See USP Controlled Room Temperature. Protect from light and moisture.
Animi-3®
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
U.S. Patent No. 8,075,910; 8,173,160
Rx Only
Animi-3® 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).
Animi-3® Capsules are indicated for improving nutritional status in conditions requiring Essential Fatty Acids, Vitamin B12, Vitamin B6, Vitamin D3 and Folic Acid supplementation.
This product is contraindicated in patients with a known hyper-sensitivity to any of the ingredients.
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.
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.
Safety and effectiveness in pediatric patients have not been established.
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.
Allergic sensitization has been reported following oral, enteral and parenteral administration of folic acid.
Adults – One capsule per day or as directed by a physician.
Animi-3® supplied as orange opaque oblong capsules. Each capsule in imprinted with “Animi-3” in black opacode. Animi-3® Capsules are available in bottles of 60 capsules (NDC 66213-543-60).
Dispense in a well-closed, tight light-resistant container as defined in the USP using a child-resistant closure.
Store at 20-25°C (68-77°F). See USP Controlled Room Temperature. Protect from light and moisture.
PBM Pharmaceuticals, Inc.
Charlottesville, VA 22902
Rev. 0113
©2013 All Rights Reserved.
NDC 66213-543-60 60 Capsules
Animi-3®
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
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1193046 | cholecalciferol 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] | SBD | 2 |
| 1193037 | cholecalciferol 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 | SCD | 2 |
| 1193037 | cholecalciferol 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 | SY | 2 |
| 1193046 | cholecalciferol 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] | SY | 2 |
| 1193037 | cholecalciferol 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 | SY | 2 |
| 1193046 | cholecalciferol 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] | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| CHOLECALCIFEROL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CYANOCOBALAMIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| OMEGA-3 FATTY ACIDS Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PYRIDOXINE Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20170310 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f6766515-27b8-72de-2010-167151236ace | Product name | 7 | 20251021 |
| ef9a935e-31b7-402c-a66c-716cdfe4f126 | Product name | 9 | 20241218 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| b82b4008-22fd-05f5-6cc6-c0a6e81c65b8 | Product name | 2 | 20240805 |
| 115c5bd2-98e1-4a98-8292-90803ca7e851 | Product name | 1 | 20220127 |
| 91c62db0-0295-c81c-d10a-0856c259edd6 | Product name | 2 | 20200428 |
| d32bc2b8-0bb7-2216-87aa-24639646e202 | Product name | 3 | 20190619 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| d206bb34-ea65-399d-70d9-834f22dc2c18 | Product name | 3 | 20170724 |
| 5e18e798-5614-cf5c-0185-38b1cb77a093 | Product name | 2 | 20160822 |
| 60c52429-fcef-eb54-2387-43bc9e4f296b | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66213-543-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-eb75-f424-e053-dadaa90a57ce | PBM - Animi-3® - Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66213-543-60 | Animi-3 | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 66213-543 | ANIMI-3 (FOLIC ACID, CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT, PHYTOSTEROLS) CAPSULE [PBM PHARMACEUTICALS, INC] | 2 | Legacy NDC, 1 package rows | 20130208_469db782-ba46-485d-b5b7-1ef32805bdb7.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66213-543-60 | EA - Each | 66213-543 | 2c6e3d13-fd88-4e29-9da4-d24519420f3c | 1 | 2013-04-01 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Cholecalciferol | ACTIVE INGREDIENT | 1C6V77QF41 | 2 | |
| Cyanocobalamin | ACTIVE INGREDIENT | P6YC3EG204 | 2 | |
| Doconexent | ACTIVE INGREDIENT | ZAD9OKH9JC | 2 | |
| Folic Acid | ACTIVE INGREDIENT | 935E97BOY8 | 2 | |
| Icosapent | ACTIVE INGREDIENT | AAN7QOV9EA | 2 | |
| Omega-3 Fatty Acids | ACTIVE INGREDIENT | 71M78END5S | 2 | |
| Pyridoxine Hydrochloride | ACTIVE INGREDIENT | 68Y4CF58BV | 2 | |
| Soy Sterol | ACTIVE INGREDIENT | PL360EPO9J | 2 | |
| Cholecalciferol | ACTIVE MOIETY | 1C6V77QF41 | 2 | |
| Cyanocobalamin | ACTIVE MOIETY | P6YC3EG204 | 2 | |
| Doconexent | ACTIVE MOIETY | ZAD9OKH9JC | 2 | |
| Folic Acid | ACTIVE MOIETY | 935E97BOY8 | 2 | |
| Icosapent | ACTIVE MOIETY | AAN7QOV9EA | 2 | |
| Omega-3 Fatty Acids | ACTIVE MOIETY | 71M78END5S | 2 | |
| Pyridoxine | ACTIVE MOIETY | KV2JZ1BI6Z | 2 | |
| Soy Sterol | ACTIVE MOIETY | PL360EPO9J | 2 | |
| Alpha-Tocopherol | INACTIVE INGREDIENT | H4N855PNZ1 | 2 | |
| Ascorbic Acid | INACTIVE INGREDIENT | PQ6CK8PD0R | 2 | |
| Ascorbyl Palmitate | INACTIVE INGREDIENT | QN83US2B0N | 2 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | 2 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 2 | |
| Gelatin | INACTIVE INGREDIENT | 2G86QN327L | 2 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| Lecithin, Soybean | INACTIVE INGREDIENT | 1DI56QDM62 | 2 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 66213-543 | 66213-543-60 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Folic Acid | 935E97BOY8 | ACTIB |
| Cholecalciferol | 1C6V77QF41 | ACTIB |
| Pyridoxine Hydrochloride | 68Y4CF58BV | ACTIB |
| Cyanocobalamin | P6YC3EG204 | ACTIB |
| Omega-3 Fatty Acids | 71M78END5S | ACTIB |
| Doconexent | ZAD9OKH9JC | ACTIB |
| Icosapent | AAN7QOV9EA | ACTIB |
| Soy Sterol | PL360EPO9J | ACTIB |
| Ascorbic Acid | PQ6CK8PD0R | IACT |
| Alpha-Tocopherol | H4N855PNZ1 | IACT |
| Ascorbyl Palmitate | QN83US2B0N | IACT |
| Gelatin | 2G86QN327L | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Titanium Dioxide | 15FIX9V2JP | IACT |
| FD&C Red No. 40 | WZB9127XOA | IACT |
| Water | 059QF0KO0R | IACT |
| Lecithin, Soybean | 1DI56QDM62 | IACT |
| FD&C Yellow No. 6 | H77VEI93A8 | IACT |
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SPONGE / TOPICAL | 0.01 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| Gelatin | GELATIN | 2G86QN327L | TABLET, ORALLY DISINTEGRATING / SUBLINGUAL | 13 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| Gelatin | GELATIN | 2G86QN327L | TABLET, DELAYED RELEASE / ORAL | 19 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.02 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SOAP / TOPICAL | 1 %w/w | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, COATED / ORAL | 0.1 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| Gelatin | GELATIN | 2G86QN327L | DROPS / NASAL | 50 mg/1ml | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | GUM, CHEWING / BUCCAL | 48 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| Ascorbic Acid | ASCORBIC ACID | PQ6CK8PD0R | SOLUTION / RESPIRATORY (INHALATION) | 0.04 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | ELIXIR / ORAL | 12.5 mg/5ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| Lecithin, Soybean | SOYBEAN LECITHIN | 1DI56QDM62 | POWDER, FOR SUSPENSION / ORAL | 39 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| Ascorbic Acid | ASCORBIC ACID | PQ6CK8PD0R | GEL / TOPICAL | 7 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET / BUCCAL | 1 mg | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SOLUTION / ORAL | 40 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| Ascorbic Acid | ASCORBIC ACID | PQ6CK8PD0R | SYRUP / ORAL | 200 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| Gelatin | GELATIN | 2G86QN327L | CAPSULE, DELAYED RELEASE / ORAL | 1791 mg | ||
| Gelatin | GELATIN | 2G86QN327L | INJECTION, SUSPENSION / INTRAMUSCULAR | 1.3 mg | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED PELLETS / ORAL | NA | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CONCENTRATE / ORAL | 0.03 mg/5ml | ||
| Alpha-Tocopherol | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | OINTMENT / TOPICAL | NA | ||
| Lecithin, Soybean | SOYBEAN LECITHIN | 1DI56QDM62 | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.1 %w/w | ||
| Ascorbic Acid | ASCORBIC ACID | PQ6CK8PD0R | CONCENTRATE / ORAL | 6 mg/1ml | ||
| Gelatin | GELATIN | 2G86QN327L | INJECTION / SUBCUTANEOUS | 16 %w/v | ||
| Gelatin | GELATIN | 2G86QN327L | POWDER / ORAL | 100 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| Alpha-Tocopherol | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, CHEWABLE / ORAL | 0.1 mg | ||
| Ascorbic Acid | ASCORBIC ACID | PQ6CK8PD0R | SOLUTION / ORAL | 600 mg | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE / ORAL | 7 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| Alpha-Tocopherol | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | CAPSULE / ORAL | 16 mg | ||
| Lecithin, Soybean | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, FILM COATED / ORAL | 0.33 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| Ascorbic Acid | ASCORBIC ACID | PQ6CK8PD0R | INJECTION, SOLUTION / INTRAVENOUS | 4 mg | ||
| Gelatin | GELATIN | 2G86QN327L | TABLET / ORAL | 46 mg | ||
| Ascorbic Acid | ASCORBIC ACID | PQ6CK8PD0R | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 0.11 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 5e947d00-9af4-4632-bca3-e8b30ce39100 | 469db782-ba46-485d-b5b7-1ef32805bdb7 | 2013-02-06 | Warnings, Adverse reactions | 5e947d00-9af4-4632-bca3-e8b30ce39100 469db782-ba46-485d-b5b7-1ef32805bdb7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.