| NDC | 15370-260-30 |
| Set ID | 5779a12c-3ff1-4c46-bed3-3769bfd2bc06 |
| Category | DIETARY SUPPLEMENT |
| Packager | Carwin Pharmaceutical Associates, LLC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
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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
- CONTRAINDICATIONS
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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.
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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
- DOSAGE AND ADMINISTRATION
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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
- SAFE HANDLING WARNING
- HEALTH CLAIM
- PRINCIPAL DISPLAY PANEL - 30 Softgel Blister Pack Carton
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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 filledProduct 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)
