Dexatran Multivitamin

Dexatran Multivitamin
SPL v2
SPL
SPL Set ID e052d2c2-7a3f-37be-e053-2a95a90af21c
Routes
ORAL CUTANEOUS
Published
Effective Date 2022-06-06
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Cation (6.9 mg) Riboflavin (6 mg) Niacinamide (30 mg) Pyridoxine (5 mg) Folic Acid (1 mg) Cyanocobalamin (15 ug) Pantothenic Acid (10 mg) Ascorbic Acid (200 mg) Zinc Cation (18.2 mg) Manganese Cation (2+) (1.3 mg) Ferrous Cation (18 mg) Cupric Cation (0.8 mg)
Inactive Ingredients
Silicon Dioxide Microcrystalline Cellulose Gellan Gum (low Acyl) Hypromelloses Water Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: brown Size: 23 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-02-15

Description

Active ingredients: Each capsule contains: Vitamin C (as sodium ascorbate).................................200 mg Thiamin (as thiamine mononitrate)............................... 10 mg Riboflavin....................................................................... 6 mg Niacin (as niacinamide)................................................ 30 mg Vitamin B6 (as pyridoxine hydrochloride)....................... 5 mg Folate (as folic acid)...... 1667 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin).............................. 15 mcg Pantothenic Acid (as d-calcium pantothenate)............. 10 mg Iron (as ferrous fumarate)............................................ 18 mg Magnesium (as magnesium sulfate)............................ 6.9 mg Zinc (as zinc sulfate).................................................. 18.2 mg Copper (as cupric sulfate)........................................... 0.8 mg Manganese (as manganese sulfate)............................ 1.3 mg Other Ingredients: Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Silicon Dioxide, Vegetable Capsule.

Indications and Usage

Dexatran™ is indicated to provide dietary management for men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.

Dosage and Administration

Adults (persons over 12 years of age) one (1) Dexatran™ capsule daily, between meals or as directed by a physician. Do not administer to children under the age of 12.

Contraindications

This product is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

Adverse Reactions

Folic Acid: Allergic sensitizations has been reported following both oral and parenteral administration of folic acid. Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Dexatran™ after meals may control occasional gastrointestinal disturbances. Dexatran™ is best absorbed when taken at bedtime. Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

Drug Interactions

Dexatran™ is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin or Clopidogrel).

How Supplied

Dexatran™ are transparent capsules in bottles containing 30 capsules – NDC 59088-643-54. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Do not use if bottle seal is broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at controlled room temperature 20o to 25oC (68o to 77oF). [See USP]. Protect from light and moisture and avoid excessive heat.


Medication Information

Indications and Usage

Dexatran™ is indicated to provide dietary management for men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.

Dosage and Administration

Adults (persons over 12 years of age) one (1) Dexatran™ capsule daily, between meals or as directed by a physician. Do not administer to children under the age of 12.

Contraindications

This product is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

Adverse Reactions

Folic Acid: Allergic sensitizations has been reported following both oral and parenteral administration of folic acid. Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Dexatran™ after meals may control occasional gastrointestinal disturbances. Dexatran™ is best absorbed when taken at bedtime. Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

Drug Interactions

Dexatran™ is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin or Clopidogrel).

How Supplied

Dexatran™ are transparent capsules in bottles containing 30 capsules – NDC 59088-643-54. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Do not use if bottle seal is broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at controlled room temperature 20o to 25oC (68o to 77oF). [See USP]. Protect from light and moisture and avoid excessive heat.

Description

Active ingredients: Each capsule contains: Vitamin C (as sodium ascorbate).................................200 mg Thiamin (as thiamine mononitrate)............................... 10 mg Riboflavin....................................................................... 6 mg Niacin (as niacinamide)................................................ 30 mg Vitamin B6 (as pyridoxine hydrochloride)....................... 5 mg Folate (as folic acid)...... 1667 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin).............................. 15 mcg Pantothenic Acid (as d-calcium pantothenate)............. 10 mg Iron (as ferrous fumarate)............................................ 18 mg Magnesium (as magnesium sulfate)............................ 6.9 mg Zinc (as zinc sulfate).................................................. 18.2 mg Copper (as cupric sulfate)........................................... 0.8 mg Manganese (as manganese sulfate)............................ 1.3 mg Other Ingredients: Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Silicon Dioxide, Vegetable Capsule.

Overdose:

Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300 mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Dexatran™ should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of reach of children.

Warnings:
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.

Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.

Treatment:

For specific therapy, exchange transfusion and chelating agents shouldbe used. For general management, perform gastric lavage with sodium bicarbonate solution or milk.



Administer intravenous fluids and electrolytes and use oxygen.

Dexatran™

Manufactured in the USA by:

PureTek Corporation

Panorama City, CA 91402

Questions? Call toll-free:

1-877-921-7873

Description:

Active ingredients:

Each capsule contains:


Vitamin C (as sodium ascorbate).................................200 mg

Thiamin (as thiamine mononitrate)............................... 10 mg

Riboflavin....................................................................... 6 mg

Niacin (as niacinamide)................................................ 30 mg

Vitamin B6 (as pyridoxine hydrochloride)....................... 5 mg

Folate (as folic acid)...... 1667 mcg DFE (1000 mcg folic acid)

Vitamin B12 (as cyanocobalamin).............................. 15 mcg

Pantothenic Acid (as d-calcium pantothenate)............. 10 mg

Iron (as ferrous fumarate)............................................ 18 mg

Magnesium (as magnesium sulfate)............................ 6.9 mg

Zinc (as zinc sulfate).................................................. 18.2 mg

Copper (as cupric sulfate)........................................... 0.8 mg

Manganese (as manganese sulfate)............................ 1.3 mg

Other Ingredients:

Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Silicon Dioxide, Vegetable Capsule.

Precautions:

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.



There is a potential danger in administering folic acid to patients with undiagnosed anemia, since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B 12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia.



The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

For use on the order of a healthcare practitioner.

Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

How Supplied:

Dexatran™ are transparent capsules in bottles containing 30 capsules – NDC 59088-643-54. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

Do not use if bottle seal is broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at controlled room temperature 20o to 25oC (68o to 77oF). [See USP].

Protect from light and moisture and avoid excessive heat.

Adverse Reactions:

Folic Acid: Allergic sensitizations has been reported following both oral and parenteral administration of folic acid.



Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Dexatran™ after meals may control occasional gastrointestinal disturbances. Dexatran™ is best absorbed when taken at bedtime.

Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

Contraindications:

This product is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

Drug Interactions:

Dexatran™ is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin or Clopidogrel).

Indications and Usage:

Dexatran™ is indicated to provide dietary management for men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.

Dosage and Administration:

Adults (persons over 12 years of age) one (1) Dexatran™ capsule daily, between meals or as directed by a physician. Do not administer to children under the age of 12.


Structured Label Content

Overdose: (OVERDOSE:)

Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300 mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Dexatran™ should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of reach of children.

Warnings:
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.

Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.

Treatment:

For specific therapy, exchange transfusion and chelating agents shouldbe used. For general management, perform gastric lavage with sodium bicarbonate solution or milk.



Administer intravenous fluids and electrolytes and use oxygen.

Dexatran™

Manufactured in the USA by:

PureTek Corporation

Panorama City, CA 91402

Questions? Call toll-free:

1-877-921-7873

Description: (DESCRIPTION:)

Active ingredients:

Each capsule contains:


Vitamin C (as sodium ascorbate).................................200 mg

Thiamin (as thiamine mononitrate)............................... 10 mg

Riboflavin....................................................................... 6 mg

Niacin (as niacinamide)................................................ 30 mg

Vitamin B6 (as pyridoxine hydrochloride)....................... 5 mg

Folate (as folic acid)...... 1667 mcg DFE (1000 mcg folic acid)

Vitamin B12 (as cyanocobalamin).............................. 15 mcg

Pantothenic Acid (as d-calcium pantothenate)............. 10 mg

Iron (as ferrous fumarate)............................................ 18 mg

Magnesium (as magnesium sulfate)............................ 6.9 mg

Zinc (as zinc sulfate).................................................. 18.2 mg

Copper (as cupric sulfate)........................................... 0.8 mg

Manganese (as manganese sulfate)............................ 1.3 mg

Other Ingredients:

Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Silicon Dioxide, Vegetable Capsule.

Precautions:

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.



There is a potential danger in administering folic acid to patients with undiagnosed anemia, since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B 12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia.



The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

For use on the order of a healthcare practitioner.

Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

How Supplied:

Dexatran™ are transparent capsules in bottles containing 30 capsules – NDC 59088-643-54. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

Do not use if bottle seal is broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at controlled room temperature 20o to 25oC (68o to 77oF). [See USP].

Protect from light and moisture and avoid excessive heat.

Adverse Reactions:

Folic Acid: Allergic sensitizations has been reported following both oral and parenteral administration of folic acid.



Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Dexatran™ after meals may control occasional gastrointestinal disturbances. Dexatran™ is best absorbed when taken at bedtime.

Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

Contraindications:

This product is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

Drug Interactions:

Dexatran™ is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin or Clopidogrel).

Indications and Usage:

Dexatran™ is indicated to provide dietary management for men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.

Dosage and Administration:

Adults (persons over 12 years of age) one (1) Dexatran™ capsule daily, between meals or as directed by a physician. Do not administer to children under the age of 12.


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