Supplement Label Index / Carwin Pharmaceutical Associates

Tri Start One

Carwin Pharmaceutical Associates · Softgel Capsule · On market

Matched compounds

How these doses compare

• Folate (Vitamin B9): 1,568 mcg DFE per serving — higher than 93% of 5,690 on-market products declaring it (market median 666 mcg DFE).
• Iodine: 200 elemental mcg per serving — higher than 87% of 6,521 on-market products declaring it (market median 150 elemental mcg).
• Iron: 35 elemental mg per serving — higher than 95% of 7,061 on-market products declaring it (market median 5 elemental mg).
• Magnesium: 0.01 elemental mg per serving — at or below the lowest declared dose among 14,120 on-market products declaring it (market median 80 elemental mg).
• Niacin (Vitamin B3): 18 mg NE per serving — higher than 32% of 11,982 on-market products declaring it (market median 20 mg NE).
• Riboflavin (Vitamin B2): 2 mg per serving — higher than 36% of 9,701 on-market products declaring it (market median 4 mg).
• Vitamin B6 (Pyridoxine): 50 mg per serving — higher than 85% of 15,068 on-market products declaring it (market median 6 mg).
• Vitamin C: 55 mg per serving — higher than 22% of 18,522 on-market products declaring it (market median 120 mg).
• Vitamin D: 25 mcg per serving — higher than 57% of 13,822 on-market products declaring it (market median 17.5 mcg).

Per serving as declared; serving sizes and daily directions differ between products.

Excipients

• Annatto
• Beeswax
• Carrageenan — Food Additive Index
• Glycerin
• Modified Food Starch
• Sorbitol
• Sunflower Lecithin
• Water

Label statements

• claim: 15370-260-30
• other: AVA American Vegetarian Association K Parve (Kosher)
• other: AVA American Vegetarian Association Vegetarian
• other: K Parve (Kosher) Kosher
• identity: Prenatal Supplement
• other: One small softgel with DHA, Quatrefolic, Iron, Vitamin D and B-Complex to support your baby's growth and development.
• other: Dye, sugar, lactose, and gluten free
• claim: Rx Only
• other: Quatrefolic Contains Vitashine D3
• 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.
• warning: Contraindications: TriStart One should not be used by patients with a known history of hypersensitivity to any of the listed ingredients.
• warning: 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.
• warning: 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.
• warning: Adverse Reactions: Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those contained herein.
• warning: 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: 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.
• other: Dosage and Administration: Take one (1) softgel daily, or as directed by a healthcare practitioner.
• 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.
• other: 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.
• other: Made with Vitashine - a plant-derived Vegan D3 made from Lichen extract. life's DHA is a vegetarian source of Docosahexaenoic Acid (DHA).
• warning: Keep this product out of reach of children.
• warning: Tamper evident: Do not use if seal is broken or missing
• claim: Rx Only
• other: 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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