Tri Start One
Product Overview
Brand: Carwin Pharmaceutical Associates
Barcode: 3 15370 26030 6
Net Contents: 30 Softgel(s)
Serving Size (Overview): 1 Softgel(s)
Product Type: Other Combinations [A1325]
Form: Softgel Capsule [E0161]
Date Entered: Dec 18, 2021
Market Status: On Market
Suggested Use (Overview): Dosage and Administration: Take one (1) softgel daily; or as directed by a healthcare practitioner.
Product Self-Roles:
- No specific self-roles defined.
Dietary Supplement Facts
| Ingredient | Category | Amount Per Serving | Unit | % Daily Value | Target Group | Serving Size (Fact) |
|---|---|---|---|---|---|---|
| Vitamin C | vitamin | 55 | mg | 92 | Pregnant and Lactating | 1 Softgel(s) |
| Vitamin D3 | vitamin | 1000 | IU | 250 | Pregnant and Lactating | 1 Softgel(s) |
| Vitamin E | vitamin | 15 | IU | 50 | Pregnant and Lactating | 1 Softgel(s) |
| Vitamin B6 | vitamin | 50 | mg | 2000 | Pregnant and Lactating | 1 Softgel(s) |
| Riboflavin | vitamin | 2 | mg | 100 | Pregnant and Lactating | 1 Softgel(s) |
| Vitamin B3 | vitamin | 18 | mg | 90 | Pregnant and Lactating | 1 Softgel(s) |
| Folate | vitamin | 1 | mg | 125 | Pregnant and Lactating | 1 Softgel(s) |
| Quatrefolic (6S)-5-Methyltetrahydrofolic Acid Glucosamine Salt | non-nutrient/non-botanical | 800 | mcg | N/A | N/A | 1 Softgel(s) |
| Folic Acid | vitamin | 568 | mcg | N/A | N/A | 1 Softgel(s) |
| Iron | mineral | 35 | mg | 194 | Pregnant and Lactating | 1 Softgel(s) |
| Iodine | mineral | 200 | mcg | 133 | Pregnant and Lactating | 1 Softgel(s) |
| Magnesium | mineral | 5 | mcg | 1 | Pregnant and Lactating | 1 Softgel(s) |
| Algal Oil | fat | 215 | mg | N/A | Pregnant and Lactating | 1 Softgel(s) |
Other Ingredients
yellow Beeswax; Sunflower Lecithin; modified Food Starch; Carrageenan; Glycerin; Sorbitol; Water; Purified; Annatto
Label Statements
Other
- 15370-260-30 Rx Only Rx Only
Seals/Symbols
- AVA American Vegetarian AssociationK Parve (Kosher)
Formulation
- AVA American Vegetarian AssociationVegetarian K Parve (Kosher) Kosher One small softgel with DHA Quatrefolic Iron Vitamin D and B-Complex to support your baby's growth and development. Dye sugar lactose and gluten free 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. 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. Made with Vitashine; a plant-derived Vegan D3 made from Lichen extract.life's DHA is a vegetarian source of Docosahexaenoic Acid (DHA).
Statement of Identity
- Prenatal Supplement
Precautions
- 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 neurological 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. Keep this product out of reach of children. Tamper evident: Do not use if seal is broken or missing
Suggested Use
- Dosage and Administration: Take one (1) softgel daily or as directed by a healthcare practitioner.
Product Specific Information
- 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.
Branding Statement(s)
- Quatrefolic is a registered trademark of Gnosis SpA. Covered by one or more claims of U.S. Patent # 7947662 CAS# 1181972-37-1.
Associated Company Information & Roles
Carwin Pharmaceuticals Associates LLC
Hazlet,
NJ
07730
Roles for this Product:
- Distributor