Tri Start One

Basic Information

Product Label

Product label for Tri Start One
Full Name: Tri Start One
Brand: Carwin Pharmaceutical Associates
Product Type: Other Combinations
Physical State: Softgel Capsule
UPC/SKU: 3 15370 26030 6
Product Version Code: Rev. 08/2017

Contact Information

Manufactured for

Name: Carwin Pharmaceuticals Associates, LLC
Address:Hazlet, NJ, 07730
Phone: 1-844-700-5011
Website: www.carwinpharma.com
Types: Distributor

Product Details

Net Contents

30 Softgel(s)(30 Softgel(s))

Serving Sizes

Unit:Softgel(s)
Quantity:1 - 1
Daily Servings:1 - 1

Target Groups

VegetarianKosherAdult Female (18 - 50 Years)LactatingGluten FreeSugar Free

Servings Per Container

30

Ingredients & Nutrition

Notes: S40-0400 DHA 400 mg/g

Amount: 215 mg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: % (Percent Daily Value not established)

Group: Algal Oil

Folate

vitamin
Amount: 1 mg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 125%

Group: Vitamin B9 (Folate)

Iodine

mineral
Forms:
  • Potassium Iodide
Amount: 200 mcg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 133%

Group: Iodine

Iron

mineral
Forms:
  • Carbonyl Iron
Amount: 35 mg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 194%

Group: Iron

Magnesium

mineral
Forms:
  • Magnesium Oxide
Amount: 5 mcg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 1%

Group: Magnesium

Riboflavin

vitamin
Forms:
  • Vitamin B2
Amount: 2 mg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 100%

Group: Vitamin B2 (Riboflavin)

Also known as: Vitamin B-2, vitamin B2, Vitamin B2, B2, activated B2, B-2, Vit. B2, pure powder B-2

UNII Code: TLM2976OFR

Vitamin B3

vitamin
Forms:
  • Niacin
Amount: 18 mg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 90%

Group: Niacin

Also known as: IP-6

UNII Code: 2679MF687A

Vitamin B6

vitamin
Forms:
  • Pyridoxine Hydrochloride
Amount: 50 mg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 2000%

Group: Vitamin B6

Vitamin C

vitamin
Forms:
  • Ascorbic Acid
Amount: 55 mg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 92%

Group: Vitamin C (unspecified)

Vitamin D3

vitamin
Forms:
  • Cholecalciferol
Amount: 1000 IU
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 250%

Group: Vitamin D

Also known as: Cholecalciferol, Vitashine vegan Cholecaciferol, Vitashine, Vitashine D3 Cholecalciferol, Vitashine vegan Cholecalciferol, natural Cholecalciferol, plant-based Cholecalciferol, vegan Cholecalciferol, fermented Cholecalciferol, Vitashine D3

UNII Code: 1C6V77QF41

Vitamin E

vitamin
Forms:
  • D-Alpha-Tocopherol
Amount: 15 IU
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 50%

Group: Vitamin E

Also known as: Sun E 900, Naturall-e, Sunvitol, Sunvitol E500, Delta Gold Tocotrienol

UNII Code: H4N855PNZ1

Annatto

botanical

Group: Annatto

Carrageenan

complex carbohydrate

Group: Carrageenan

UNII Code: 5C69YCD2YJ

Group: Vitamin D

Also known as: Vitamin D3

UNII Code: 1C6V77QF41

Folacin

vitamin

Group: Vitamin B9 (folic acid)

Also known as: Folic Acid

Folic Acid

vitamin

Group: Folate

Also known as: Orgen-FA, Vitamin B9, Quatrefolic, Folacin, CitraFolic, B9, Folate

UNII Code: 935E97BOY8

Group: Glycerol

Group: modified Starch

Group: Vitamin B3 (Niacin)

Also known as: Vitamin B3

UNII Code: 2679MF687A

Group: Vitamin B6 (pyridoxine)

Also known as: Vitamin B6

Quali-C

vitamin

Group: Vitamin C (ascorbic acid)

Also known as: Vitamin C

Sorbitol

non-nutrient/non-botanical

Group: Sorbitol

UNII Code: 506T60A25R

Group: lecithin

Vit. B2

vitamin

Group: Vitamin B2 (unspecified)

Also known as: Riboflavin

Vitamin B9

vitamin

Group: Folate

Also known as: Folic Acid, Folate

UNII Code: 935E97BOY8

Group: Water

UNII Code: 059QF0KO0R

yellow Beeswax

animal part or source

Group: Beeswax

Product Statements

General Statements: All Other Content

15370-260-30

Seals/Symbols

AVA American Vegetarian Association K Parve (Kosher)

Formulation re: Vegetarian/Vegan

AVA American Vegetarian Association Vegetarian

Formula re: Kosher

K Parve (Kosher) Kosher

FDA Statement of Identity

Prenatal Supplement

Formula re: Contains

One small softgel with DHA, Quatrefolic, Iron, Vitamin D and B-Complex to support your baby's growth and development.

Formulation re: Does NOT Contain

Dye, sugar, lactose, and gluten free

General Statements: All Other Content

Rx Only

Formula re: Contains

Quatrefolic Contains Vitashine D3

Formulation re: Other

Indications and Usage: TriStart One is a dietary supplement indicated to provide vitamin , mineral and DHA supplementation throughout pregnancy and in the postnatal period.

Precautions re: All Other

Contraindications: TriStart One should not be used by patients with a known history of hypersensitivity to any of the listed ingredients.

Precautions re: Pregnant or Nursing or Prescription Medications

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.

Precautions re: All Other

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 neurological manifestations remain progressive.

Precautions re: All Other

Adverse Reactions: Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those contained herein.

Precautions re: All Other

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.

Precautions re: Children

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.

Suggested/Recommended/Usage/Directions

Dosage and Administration: Take one (1) softgel daily, or as directed by a healthcare practitioner.

Formulation re: Other

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.

Storage

Store at 20 degrees - 25 degrees Celsius (68 degrees - 77 degrees Fahrenheit); excursions permitted to 15 degrees - 30 degrees Celsius (50 degrees - 86 degrees Fahrenheit). [See USP Controlled Room Temperature]. Protect from light, moisture and heat.

Formula re: Contains

Made with Vitashine - a plant-derived Vegan D3 made from Lichen extract. life's DHA is a vegetarian source of Docosahexaenoic Acid (DHA).

Precautions re: Children

Keep this product out of reach of children.

Precautions re: All Other

Tamper evident: Do not use if seal is broken or missing

General Statements: All Other Content

Rx Only

Brand IP Statement(s) re: (c), (TM), (SM)

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.

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