Indications and uses
TriStart™ ONE is a dietary supplement indicated to provide vitamin, mineral and DHA supplementation throughout pregnancy and in the postnatal period.
TriStart ONE
- Manufacturer
- Carwin Pharmaceutical Associates, LLC
- Effective date
- 2017-09-20
- Label type
- DIETARY SUPPLEMENT
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:11:51
Label at a glance#
ProductTriStart ONE
Active ingredientASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, D-, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, FOLIC ACID, Iron, POTASSIUM IODIDE, MAGNESIUM OXIDE, SCHIZOCHYTRIUM DHA OIL
Label structure12 sections
Dosage and administration
Take one (1) softgel daily, or as directed by a healthcare practitioner.
Contacts and useful links#
Websitewww.carwinpharma.com
www.carwinpharma.com
www.carwinpharma.comLabel contents#
Full prescribing information#
STATEMENT OF IDENTITY SECTION
| Supplement Facts | ||
|---|---|---|
| Serving Size: 1 Softgel | Servings per container: 30 | |
| Amount Per Serving: | % Daily Value In Pregnancy | |
| Vitamin C (Ascorbic Acid) | 55 mg | 92% |
| Vitamin D3 (Cholecalciferol) | 1000 IU | 250% |
| Vitamin E (D-Alpha-Tocopherol) | 15 IU | 50% |
| Vitamin B6 (Pyridoxine HCl) | 50 mg | 2000% |
| Riboflavin (Vitamin B2) | 2 mg | 100% |
| Vitamin B3 (Niacin) | 18 mg | 90% |
| Folate ( as 800 mcg Quatrefolic® ((6S-5-methyltetrahydrofolic acid, glucosamine salt, molar equivalent to 432 mcg of Folic Acid), and 568 mcg of folic acid)) | 1 mg | 125% |
| Iron (Carbonyl Iron) | 35 mg | 194% |
| Iodine (Potassium Iodide) | 200 mcg | 133% |
| Magnesium (Magnesium Oxide) | 5 mcg | 1% |
| Algal Oil (Algal Oil, life's DHA® S40-0400 DHA 400mg/g) | 215 mg | * |
* Percent Daily Value not established.
Other Ingredients: Yellow Beeswax, Sunflower Lecithin, Modified Food Starch, Carrageenan, Glycerin, Sorbitol, Purified Water, and Annatto.
Quatrefolic®
CONTAINS VITASHINE D3
INDICATIONS AND USAGE
TriStart™ ONE is a dietary supplement indicated to provide vitamin, mineral and DHA supplementation throughout pregnancy and in the postnatal period.
CONTRAINDICATIONS
TriStart™ ONE should not be used by patients with a known history of hypersensitivity to any of the listed ingredients.
PRECAUTIONS
General
TriStart™ ONE is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized pyridoxine.
Folic Acid
Administration of Folic Acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurologic manifestations remain progressive.
ADVERSE REACTIONS
Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those contained herein. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.
Call your doctor for medical advice about side effects. You may report side effects or obtain product information by calling Carwin Pharmaceutical Associates, LLC at 1-844-700-5011.
WARNINGS SECTION
| 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. |
DOSAGE AND ADMINISTRATION
Take one (1) softgel daily, or as directed by a healthcare practitioner.
HOW SUPPLIED
TriStart™ ONE is available as an oval, annatto softgel capsule with an etched imprint "ONE". Supplied in a carton unit dose pack of 30 (3 child-resistant blister cards of 10 softgels each) 15370-260-30 and a professional sample 15370-260-03.
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from light, moisture and heat.
HEALTH CLAIM SECTION
Vegetarian capsule.
Made with Vitashine™ - a plant-derived Vegan D3 made from Lichen Extract.
life's DHA® is a vegetarian source of Docosahexaenoic Acid (DHA).
SAFE HANDLING WARNING SECTION
KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.
TAMPER EVIDENT: Do not use if seal is broken or missing.
HEALTH CLAIM SECTION
Rx Only
Quatrefolic® is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1
Manufactured for:
Carwin Pharmaceutical Associates, LLC
Hazlet, NJ 07730
www.carwinpharma.com
(Rev.08/2017)
PRINCIPAL DISPLAY PANEL - 30 Softgel Blister Pack Carton
15370-260-30
AVA™
American Vegetarian Association
K
PARVE
TriStart™ One
PRENATAL SUPPLEMENT
One small softgel with DHA, Quatrefolic®,
Iron, Vitamin D and B-Complex to support
your baby's growth and development.
Kosher ✔
Vegetarian ✔
Dye, Sugar,
Lactose, and
Gluten
FREE
30 Softgels
Rx Only
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 15370-260-30 | EA - Each | 15370-260 | d01ae048-4b9f-446b-9557-674202118f86 | 1 | 2017-11-06 |
Products#
Every source-derived product name is available through these pages.
- TriStart ONE
- ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, riboflavin, niacin, folic acid, iron, potassium iodide, magnesium oxide, and schizochytrium dha oil
- ASCORBIC ACID
- CHOLECALCIFEROL
- .ALPHA.-TOCOPHEROL, D-
- PYRIDOXINE HYDROCHLORIDE
- PYRIDOXINE
- RIBOFLAVIN
- NIACIN
- FOLIC ACID
- Iron
- POTASSIUM IODIDE
- IODIDE ION
- MAGNESIUM OXIDE
- MAGNESIUM CATION
- SCHIZOCHYTRIUM DHA OIL
- Yellow wax
- LECITHIN, SUNFLOWER
- CARRAGEENAN
- Glycerin
- Sorbitol
- Water
- Annatto
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 15370-260 | 15370-260-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASCORBIC ACID | PQ6CK8PD0R | ACTIB |
| CHOLECALCIFEROL | 1C6V77QF41 | ACTIB |
| .ALPHA.-TOCOPHEROL, D- | N9PR3490H9 | ACTIB |
| PYRIDOXINE HYDROCHLORIDE | 68Y4CF58BV | ACTIB |
| RIBOFLAVIN | TLM2976OFR | ACTIB |
| NIACIN | 2679MF687A | ACTIB |
| FOLIC ACID | 935E97BOY8 | ACTIB |
| Iron | E1UOL152H7 | ACTIB |
| POTASSIUM IODIDE | 1C4QK22F9J | ACTIM |
| MAGNESIUM OXIDE | 3A3U0GI71G | ACTIB |
| SCHIZOCHYTRIUM DHA OIL | 2GQR19D8A4 | ACTIB |
| Yellow wax | 2ZA36H0S2V | IACT |
| LECITHIN, SUNFLOWER | 834K0WOS5G | IACT |
| CARRAGEENAN | 5C69YCD2YJ | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Sorbitol | 506T60A25R | IACT |
| Water | 059QF0KO0R | IACT |
| Annatto | 6PQP1V1B6O | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ascorbic Acid | ASCORBIC ACID | Renova Pharmaceuticals LLC | a6481bae-2397-44c7-a51d-4f47ad91bd2c | 2026-08-19 | Warnings, Adverse reactions | ASCORBIC ACID |
| Ascor | ASCORBIC ACID | McGuff Pharmaceuticals, Inc. | 388aad52-fc01-4784-9791-1dbc80c69306 | 2026-05-29 | Warnings, Adverse reactions | ASCORBIC ACID |
| Ascorbic Acid | ASCORBIC ACID | Fresenius Kabi USA, LLC | 1606e29f-0e80-4069-b688-daab9cbff20a | 2025-12-17 | Warnings, Adverse reactions | ASCORBIC ACID |
| Skin Renewing Serum | ASCORBIC ACID | Guangzhou Danting Bath&Body Care Industry Co. Ltd | 396c2a8d-ac95-cbef-e063-6294a90aff39 | 2025-08-23 | Warnings | ASCORBIC ACID |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.