TRISTART ONE- ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, riboflavin, niacin, folic acid, iron, potassium iodide, magnesium oxide, and schizochytrium dha oil capsule, liquid filled 
Carwin Pharmaceutical Associates, LLC

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TriStart™ One
PRENATAL SUPPLEMENT

Supplement Facts
Serving Size: 1 SoftgelServings per container: 30
Amount Per Serving:% Daily Value
In Pregnancy
*
Percent Daily Value not established.
Vitamin C (Ascorbic Acid)55 mg92%
Vitamin D3 (Cholecalciferol)1000 IU250%
Vitamin E (D-Alpha-Tocopherol)15 IU50%
Vitamin B6 (Pyridoxine HCl)50 mg2000%
Riboflavin (Vitamin B2)2 mg100%
Vitamin B3 (Niacin)18 mg90%
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 mg125%
Iron (Carbonyl Iron)35 mg194%
Iodine (Potassium Iodide)200 mcg133%
Magnesium (Magnesium Oxide)5 mcg1%
Algal Oil (Algal Oil, life's DHA® S40-0400 DHA 400mg/g)215 mg*

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.

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.

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).

KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

TAMPER EVIDENT: Do not use if seal is broken or missing.

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

Principal Display Panel - 30 Softgel Blister Pack Carton
TRISTART ONE 
ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, riboflavin, niacin, folic acid, iron, potassium iodide, magnesium oxide, and schizochytrium dha oil capsule, liquid filled
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:15370-260
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID55 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL1000 [iU]
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-15 [iU]
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE50 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN2 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN18 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron35 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION200 ug
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE5 ug
SCHIZOCHYTRIUM DHA OIL (UNII: 2GQR19D8A4) (SCHIZOCHYTRIUM DHA OIL - UNII:2GQR19D8A4) SCHIZOCHYTRIUM DHA OIL215 ug
Inactive Ingredients
Ingredient NameStrength
Yellow wax (UNII: 2ZA36H0S2V)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
Glycerin (UNII: PDC6A3C0OX)  
Sorbitol (UNII: 506T60A25R)  
Water (UNII: 059QF0KO0R)  
Annatto (UNII: 6PQP1V1B6O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:15370-260-303 in 1 CARTON
110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT09/25/201705/03/2023
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)15 mm
imprint
Labeler - Carwin Pharmaceutical Associates, LLC (079217215)

Revised: 5/2023
 
Carwin Pharmaceutical Associates, LLC