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

TriStart ONE by

Drug Labeling and Warnings

TriStart ONE by is a Other medication manufactured, distributed, or labeled by Carwin Pharmaceutical Associates, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Supplement Facts
Serving Size: 1 Softgel	Servings per container: 30
Amount Per Serving:		% Daily Value In Pregnancy
* Percent Daily Value not established.
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	*

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

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

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

KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

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

HEALTH CLAIM

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

INGREDIENTS AND APPEARANCE

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 Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:15370-260
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	55 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	1000 [iU]
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL, D-	15 [iU]
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	50 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	2 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A)	NIACIN	18 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7)	Iron	35 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	200 ug
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM OXIDE	5 ug
SCHIZOCHYTRIUM DHA OIL (UNII: 2GQR19D8A4) (SCHIZOCHYTRIUM DHA OIL - UNII:2GQR19D8A4)	SCHIZOCHYTRIUM DHA OIL	215 ug

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:15370-260-30	3 in 1 CARTON
1		10 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		09/25/2017

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	15 mm
imprint

Labeler - Carwin Pharmaceutical Associates, LLC (079217215)