Dosage and administration
Usual dosage is one capsule daily, or as prescribed by a physician.
UltimateCare ONE
- Manufacturer
- Trigen Laboratories, Inc.
- Effective date
- 2013-06-26
- Label type
- DIETARY SUPPLEMENT
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:40:26
Label at a glance#
ProductUltimateCare ONE
Active ingredientOmega-3 Fatty Acids, Linoleic Acid, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Acetate, DL-, Folic Acid, Pyridoxine Hydrochloride, Calcium Carbonate, Iron, FERROUS ASPARTO GLYCINATE
Label structure14 sections
Contacts and useful links#
Websitewww.trigenlab.com
www.trigenlab.com
www.trigenlab.comLabel contents#
Full prescribing information#
HEALTH CLAIM SECTION
Rx Only
DESCRIPTION
UltimateCare ONE is a prescription prenatal/postnatal multivitamin/mineral capsule with omega-3 fatty acids. Each maroon softgel capsule is imprinted with "TL049."
| Supplement Facts Servings per Bottle: 30 | ||
|---|---|---|
| Serving Size: 1 Softgel Capsule Each Softgel Capsule contains | DV% for Pregnant and Lactating Women | |
| Omega-3 Fatty Acids | 330 mg | * |
| Docosahexaenoic Acid (DHA) | 260 mg | * |
| Eicosapentaenoic Acid (EPA) | 40 mg | * |
| a-Linoleic Acid (ALA) | 30 mg | * |
| Linoleic Acid | 30 mg | * |
| Vitamin C Complex† | 25 mg | 42% |
| Vitamin D3 (cholecalciferol) | 170 IU | 43% |
| Vitamin E (dl-alpha-tocopheryl acetate) | 30 IU | 100% |
| Folic Acid, USP | 1 mg | 125% |
| Vitamin B6 (pyridoxine HCl) | 25 mg | 1000% |
| Calcium (calcium carbonate) | 150 mg | 12% |
| Iron | ||
| Carbonyl iron (elemental iron) | 20 mg | 111% |
| Sumalate™‡ (elemental iron) | 7 mg | 39% |
Inactive Ingredients
Gelatin, Glycerin, Lecithin, Purified Water, Natural Creamy Orange Flavor, Carmine, Titanium Dioxide, Ethyl Vanillin, FD&C Red #40, FD&C Blue #1.
INDICATIONS
UltimateCare ONE is indicated to provide vitamin/mineral and omega-3 fatty acid supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. It is also useful for improving nutritional status prior to conception.
CONTRAINDICATIONS
This product is contraindicated in patients with known hypersensitivity to any of the ingredients.
WARNINGS
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 1.0 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.
| 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 poison control center immediately. |
THIS PRODUCT CONTAINS SOY.
PRECAUTIONS
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac functions, and of concomitant disease or other drug therapy.
ADVERSE REACTION
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DOSAGE AND ADMINISTRATION
Usual dosage is one capsule daily, or as prescribed by a physician.
HOW SUPPLIED
UltimateCare ONE is Supplied in bottles of 30 capsules.
PRODUCT CODE 13811-049-30
STORAGE
Store at 20° -25°C (68° -77°F), excursions permitted to 15° -30°C (59° -86°F) [See USP controlled room temperature].
Protect from moisture and excessive heat.
HEALTH CLAIM SECTION
Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).
SAFE HANDLING WARNING SECTION
KEEP OUT OF THE REACH OF CHILDREN.
HEALTH CLAIM SECTION
Rx Only
All prescriptions using this product shall be pursuant to statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.
Manufactured for:
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
www.trigenlab.com
Rev. 02/13
PRINCIPAL DISPLAY PANEL - 30 Softgel Capsule Bottle Label
13811-049-30
Rx Only
UltimateCare
ONE
Prenatal with DHA & EPA
30 Softgel Capsules
TRIGEN
LABORATORIES
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 13811-049-30 | EA - Each | 13811-049 | 6652511e-bdea-47a9-b0da-e2b1987d4af7 | 1 | 2013-07-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| .Alpha.-Tocopherol Acetate, DL- | ACTIVE INGREDIENT | WR1WPI7EW8 | 1 | |
| Ascorbic Acid | ACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| Calcium Carbonate | ACTIVE INGREDIENT | H0G9379FGK | 1 | |
| Cholecalciferol | ACTIVE INGREDIENT | 1C6V77QF41 | 1 | |
| FERROUS ASPARTO GLYCINATE | ACTIVE INGREDIENT | H7426RGB3L | 1 | |
| Folic Acid | ACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| Iron | ACTIVE INGREDIENT | E1UOL152H7 | 1 | |
| Linoleic Acid | ACTIVE INGREDIENT | 9KJL21T0QJ | 1 | |
| Omega-3 Fatty Acids | ACTIVE INGREDIENT | 71M78END5S | 1 | |
| Pyridoxine Hydrochloride | ACTIVE INGREDIENT | 68Y4CF58BV | 1 | |
| .ALPHA.-TOCOPHEROL, DL- | ACTIVE MOIETY | 7QWA1RIO01 | 1 | |
| ASCORBIC ACID | ACTIVE MOIETY | PQ6CK8PD0R | 1 | |
| CALCIUM CATION | ACTIVE MOIETY | 2M83C4R6ZB | 1 | |
| CHOLECALCIFEROL | ACTIVE MOIETY | 1C6V77QF41 | 1 | |
| FERROUS CATION | ACTIVE MOIETY | GW89581OWR | 1 | |
| FOLIC ACID | ACTIVE MOIETY | 935E97BOY8 | 1 | |
| IRON | ACTIVE MOIETY | E1UOL152H7 | 1 | |
| LINOLEIC ACID | ACTIVE MOIETY | 9KJL21T0QJ | 1 | |
| Omega-3 Fatty Acids | ACTIVE MOIETY | 71M78END5S | 1 | |
| PYRIDOXINE | ACTIVE MOIETY | KV2JZ1BI6Z | 1 | |
| ethyl vanillin | INACTIVE INGREDIENT | YC9ST449YJ | 1 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Pigment Red 48 | INACTIVE INGREDIENT | 07XHK4SAV6 | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- UltimateCare ONE
- Omega-3 Fatty Acids, Linoleic Acid, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Acetate, DL-, Folic Acid, Pyridoxine Hydrochloride, Calcium Carbonate, Iron, and FERROUS ASPARTO GLYCINATE
- Omega-3 Fatty Acids
- Linoleic Acid
- Ascorbic Acid
- Cholecalciferol
- .Alpha.-Tocopherol Acetate, DL-
- .ALPHA.-TOCOPHEROL, DL-
- Folic Acid
- Pyridoxine Hydrochloride
- PYRIDOXINE
- Calcium Carbonate
- CALCIUM CATION
- Iron
- FERROUS ASPARTO GLYCINATE
- FERROUS CATION
- gelatin
- glycerin
- water
- Pigment Red 48
- titanium dioxide
- ethyl vanillin
- FD&C Red No. 40
- FD&C Blue No. 1
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 13811-049 | 13811-049-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Omega-3 Fatty Acids | 71M78END5S | ACTIB |
| Linoleic Acid | 9KJL21T0QJ | ACTIB |
| Ascorbic Acid | PQ6CK8PD0R | ACTIB |
| Cholecalciferol | 1C6V77QF41 | ACTIB |
| .Alpha.-Tocopherol Acetate, DL- | WR1WPI7EW8 | ACTIM |
| Folic Acid | 935E97BOY8 | ACTIB |
| Pyridoxine Hydrochloride | 68Y4CF58BV | ACTIB |
| Calcium Carbonate | H0G9379FGK | ACTIB |
| Iron | E1UOL152H7 | ACTIB |
| FERROUS ASPARTO GLYCINATE | H7426RGB3L | ACTIM |
| gelatin | 2G86QN327L | IACT |
| glycerin | PDC6A3C0OX | IACT |
| water | 059QF0KO0R | IACT |
| Pigment Red 48 | 07XHK4SAV6 | IACT |
| titanium dioxide | 15FIX9V2JP | IACT |
| ethyl vanillin | YC9ST449YJ | IACT |
| FD&C Red No. 40 | WZB9127XOA | IACT |
| FD&C Blue No. 1 | H3R47K3TBD | IACT |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| gelatin | GELATIN | 2G86QN327L | PASTE / DENTAL | 252 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| gelatin | GELATIN | 2G86QN327L | TABLET / ORAL | 46 mg | ||
| gelatin | GELATIN | 2G86QN327L | POWDER / RESPIRATORY (INHALATION) | 100 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| gelatin | GELATIN | 2G86QN327L | SYRUP / ORAL | NA | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | MOUTHWASH / BUCCAL | NA | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | CONCENTRATE / ORAL | 0.04 mg/1ml | ||
| glycerin | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| gelatin | GELATIN | 2G86QN327L | INJECTION / INTRACAVITARY | 0.05 ml | ||
| glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / ORAL | 7 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| gelatin | GELATIN | 2G86QN327L | CAPSULE, EXTENDED RELEASE / ORAL | 1229 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| gelatin | GELATIN | 2G86QN327L | TABLET, EXTENDED RELEASE / ORAL | 239 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA | ||
| gelatin | GELATIN | 2G86QN327L | INJECTION, SUSPENSION / INTRAMUSCULAR | 1.3 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, SUGAR COATED / ORAL | NA | ||
| glycerin | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| glycerin | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| gelatin | GELATIN | 2G86QN327L | ELIXIR / ORAL | NA | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.01 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| gelatin | GELATIN | 2G86QN327L | CAPSULE, COATED PELLETS / ORAL | 65 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / DENTAL | NA | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SOLUTION / ORAL | 0.04 mg/5ml | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| gelatin | GELATIN | 2G86QN327L | POWDER / ORAL | 100 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / SUBLINGUAL | NA | ||
| gelatin | GELATIN | 2G86QN327L | SUPPOSITORY / VAGINAL | NA | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / SUBLINGUAL | 0.03 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.