Tristart Dha

Tristart Dha
SPL v3
SPL
SPL Set ID 92ccf7d4-4527-49f0-b890-1a11b5a10086
Route
ORAL
Published
Effective Date 2019-12-23
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ascorbic Acid (55 mg) Cholecalciferol (1000 [iU]) .alpha.-tocopherol, D- (15 [iU]) Thiamine Ion (1.3 mg) Riboflavin (1.8 mg) Niacin (5 mg) Pyridoxine (35 mg) Levomefolic Acid (600 ug) Folic Acid (400 ug) Cyanocobalamin (14 ug) Ferrous Cation (31 mg) Iodide Ion (200 ug) Magnesium Cation (30 mg) Doconexent (200 mg) Icosapent (15 mg)
Inactive Ingredients
Gelatin, Unspecified Glycerin Water Yellow Wax Caramel Lecithin, Soybean Orange Ethyl Vanillin

Identifiers & Packaging

Pill Appearance
Imprint: TriStart Shape: oval Color: brown Size: 10 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2015-06-01

Description

Supplement Facts Serving Size: 1 Softgel Servings per container: 30 Amount Per Serving %Daily Value %Daily Value for Pregnant and Lactating Women Vitamin C 55 mg 92% 92%   (as ascorbic acid) Vitamin D3 1000 IU 250% 250%   (as cholecalciferol) Vitamin E 15 IU 50% 50%   (as d-alpha-tocopheryl acetate) Thiamin 1.3 mg 87% 76%   (as thiamine HCl, Vitamin B1) Riboflavin (Vitamin B2) 1.8 mg 106% 90% Niacin (as nicotinic acid) 5 mg 25% 25% Vitamin B6 35 mg 1750% 1400%   (as pyridoxine HCl) Folate (as 630 mcg of L-Methylfolate Magnesium, molar equivalent to 600mcg of L-Methylfolic acid; and 400mcg of folic acid) 1 mg 250% 125% Vitamin B12 14 mcg 233% 175%   (as cyanocobalamin) Iron (as carbonyl iron) 31 mg 172% 172% Iodine 200 mcg 133% 133%   (as Potassium Iodide) Magnesium 30 mg 8% 7%   (as Magnesium Oxide) Docosahexaenoic Acid 200mg Daily Values (DV) not established.   (DHA) Eicosapentaenoate Acid 15 mg   (EPA) OTHER INGREDIENTS: Gelatin (bovine), Glycerin, Purified Water, Yellow Bees Wax, Caramel Powder, Soy Lecithin, Natural Orange Flavor, Ethyl Vanillin. Contains: Soy and Fish TriStart DHA™ Softgel capsules are dye free, lactose, gluten and sugar free. They do not contain any artificial flavors or sweeteners. TriStart DHA™ contains bovine gelatin.

Contraindications

TriStart DHA™ is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact CarWin Pharmaceutical Associates, LLC at 1-985-288-5122

How Supplied

TriStart DHA™ is available as oval, brown softgel capsules with a yellow imprint "TriStart". They are available in child-resistant bottles containing 30 softgels (15370-250-30) and in a 3ct professional sample (15370-250-03).


Medication Information

Warnings and Precautions

Caution is recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, anticonvulsant medications may interfere with folate metabolism.

Contraindications

TriStart DHA™ is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact CarWin Pharmaceutical Associates, LLC at 1-985-288-5122

How Supplied

TriStart DHA™ is available as oval, brown softgel capsules with a yellow imprint "TriStart". They are available in child-resistant bottles containing 30 softgels (15370-250-30) and in a 3ct professional sample (15370-250-03).

Description
Supplement Facts
Serving Size: 1 Softgel
Servings per container: 30
Amount Per Serving %Daily Value %Daily Value for Pregnant and Lactating Women
Vitamin C 55 mg 92% 92%
  (as ascorbic acid)
Vitamin D3 1000 IU 250% 250%
  (as cholecalciferol)
Vitamin E 15 IU 50% 50%
  (as d-alpha-tocopheryl acetate)
Thiamin 1.3 mg 87% 76%
  (as thiamine HCl, Vitamin B1)
Riboflavin (Vitamin B2) 1.8 mg 106% 90%
Niacin (as nicotinic acid) 5 mg 25% 25%
Vitamin B6 35 mg 1750% 1400%
  (as pyridoxine HCl)
Folate (as 630 mcg of L-Methylfolate Magnesium, molar equivalent to 600mcg of L-Methylfolic acid; and 400mcg of folic acid) 1 mg 250% 125%
Vitamin B12 14 mcg 233% 175%
  (as cyanocobalamin)
Iron (as carbonyl iron) 31 mg 172% 172%
Iodine 200 mcg 133% 133%
  (as Potassium Iodide)
Magnesium 30 mg 8% 7%
  (as Magnesium Oxide)
Docosahexaenoic Acid 200mg
Daily Values (DV) not established.
  (DHA)
Eicosapentaenoate Acid 15 mg
  (EPA)

OTHER INGREDIENTS: Gelatin (bovine), Glycerin, Purified Water, Yellow Bees Wax, Caramel Powder, Soy Lecithin, Natural Orange Flavor, Ethyl Vanillin.

Contains: Soy and Fish

TriStart DHA™ Softgel capsules are dye free, lactose, gluten and sugar free. They do not contain any artificial flavors or sweeteners. TriStart DHA™ contains bovine gelatin.

Adults

Take one softgel daily with or without food, or as prescribed by a healthcare practitioner.

Section 42229-5

Manufactured for:

CarWin Pharmaceutical Associates, LLC

Slidell, LA 70461

Rx

MADE IN CANADA

Rev. 05/2015

Section 44425-7

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.]

TriStart DHA™ should be administered only under the direct supervision of a healthcare practitioner.

Avoid excessive heat, light and moisture.

Keep out of reach of 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.

Indications

TriStart DHA™ is an orally administered multivitamin/multimineral fatty acid dietary supplement indicated to improve the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. TriStart DHA™ can also be beneficial in improving the nutritional status of women prior to conception.

This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent disease.

Precautions

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where 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 progress.

Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA and EPA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

Tamper Evident

Do not use if seal is broken or missing.

Children Under 12

Consult a doctor.

Do not exceed the recommended dose.

Principal Display Panel 30 Capsule Bottle Label

15370-250-30

TriStart

DHA


PRENATAL SUPPLEMENT

Dye Free, Lactose, Gluten

and Sugar Free

Rx

30 Softgels


Structured Label Content

Adults

Take one softgel daily with or without food, or as prescribed by a healthcare practitioner.

Warnings and Precautions (34071-1)

Caution is recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, anticonvulsant medications may interfere with folate metabolism.

Description (34089-3)
Supplement Facts
Serving Size: 1 Softgel
Servings per container: 30
Amount Per Serving %Daily Value %Daily Value for Pregnant and Lactating Women
Vitamin C 55 mg 92% 92%
  (as ascorbic acid)
Vitamin D3 1000 IU 250% 250%
  (as cholecalciferol)
Vitamin E 15 IU 50% 50%
  (as d-alpha-tocopheryl acetate)
Thiamin 1.3 mg 87% 76%
  (as thiamine HCl, Vitamin B1)
Riboflavin (Vitamin B2) 1.8 mg 106% 90%
Niacin (as nicotinic acid) 5 mg 25% 25%
Vitamin B6 35 mg 1750% 1400%
  (as pyridoxine HCl)
Folate (as 630 mcg of L-Methylfolate Magnesium, molar equivalent to 600mcg of L-Methylfolic acid; and 400mcg of folic acid) 1 mg 250% 125%
Vitamin B12 14 mcg 233% 175%
  (as cyanocobalamin)
Iron (as carbonyl iron) 31 mg 172% 172%
Iodine 200 mcg 133% 133%
  (as Potassium Iodide)
Magnesium 30 mg 8% 7%
  (as Magnesium Oxide)
Docosahexaenoic Acid 200mg
Daily Values (DV) not established.
  (DHA)
Eicosapentaenoate Acid 15 mg
  (EPA)

OTHER INGREDIENTS: Gelatin (bovine), Glycerin, Purified Water, Yellow Bees Wax, Caramel Powder, Soy Lecithin, Natural Orange Flavor, Ethyl Vanillin.

Contains: Soy and Fish

TriStart DHA™ Softgel capsules are dye free, lactose, gluten and sugar free. They do not contain any artificial flavors or sweeteners. TriStart DHA™ contains bovine gelatin.

Section 42229-5 (42229-5)

Manufactured for:

CarWin Pharmaceutical Associates, LLC

Slidell, LA 70461

Rx

MADE IN CANADA

Rev. 05/2015

Section 44425-7 (44425-7)

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.]

TriStart DHA™ should be administered only under the direct supervision of a healthcare practitioner.

Avoid excessive heat, light and moisture.

Keep out of reach of children.

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.

Indications (INDICATIONS)

TriStart DHA™ is an orally administered multivitamin/multimineral fatty acid dietary supplement indicated to improve the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. TriStart DHA™ can also be beneficial in improving the nutritional status of women prior to conception.

This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent disease.

Precautions (PRECAUTIONS)

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where 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 progress.

Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA and EPA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

How Supplied (HOW SUPPLIED)

TriStart DHA™ is available as oval, brown softgel capsules with a yellow imprint "TriStart". They are available in child-resistant bottles containing 30 softgels (15370-250-30) and in a 3ct professional sample (15370-250-03).

Tamper Evident

Do not use if seal is broken or missing.

Adverse Reactions (ADVERSE REACTIONS)

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact CarWin Pharmaceutical Associates, LLC at 1-985-288-5122

Contraindications (CONTRAINDICATIONS)

TriStart DHA™ is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Children Under 12 (Children under 12)

Consult a doctor.

Do not exceed the recommended dose.

Principal Display Panel 30 Capsule Bottle Label (PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label)

15370-250-30

TriStart

DHA


PRENATAL SUPPLEMENT

Dye Free, Lactose, Gluten

and Sugar Free

Rx

30 Softgels


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)