Citranatal®

Drug Facts

Composition & Product

Active Ingredients

Ascorbic Acid (120 mg) Iron (160 mg) Cholecalciferol (90 mg) .alpha.-tocopherol (400 [iU]) Thiamine Ion (30 [iU]) Riboprine (3 mg) Niacinamide (3.4 mg) Pyridoxine (20 mg) Folic Acid (1 mg) Triiodide Ion (150 ug) Zinc Oxide (25 mg) Cupric Cation (2 mg) Docusate (50 mg)

Inactive Ingredients

Povidones Cellulose, Microcrystalline Ferrous Gluconate Titanium Dioxide Croscarmellose Sodium Niacinamide Acrylic Acid Magnesium Silicate Magnesium Stearate Thiamine Mononitrate Shellac Ethyl Vanillin Vitamin A Palmitate

Identifiers & Packaging

Pill Appearance

Imprint: CN;90 Shape: capsule Color: brown Size: 10 mm Score: 2

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2010-02-01

Medication Information

Recent Major Changes

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

Dosage and Administration

One tablet and one capsule daily or as directed by a physician.

Contraindications

This product 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.

How Supplied

Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0829-30

To report a serious adverse event or obtain product information, call (210) 696-8400.

50261

C01 Rev 011110

DHA capsules manufactured for:

MISSION PHARMACAL COMPANY

San Antonio, TX USA 78230 1355

Prenatal tablets manufactured by:

MISSION PHARMACAL COMPANY

San Antonio, TX USA 78230 1355

Description

CitraNatal^® 90 DHA is a prescription prenatal/postnatal multivitamin/mineral tablet with Ferr-Ease^®, a patented dual-iron delivery comprising both a quick release and slow release iron, and a capsule of an essential fatty acid. The prenatal vitamin is a scored, white, oval multivitamin/mineral tablet. The tablet is debossed “CN 90” on one side and “08” bisect “29” on the other. The essential fatty acid DHA capsule is caramel colored and contains a light yellow to orange semi-solid mixture.

Each prenatal tablet contains:

Vitamin C (Ascorbic acid)	120 mg
Calcium (Calcium citrate)	160 mg
Iron (Carbonyl iron, ferrous gluconate)	90 mg
Vitamin D3 (Cholecalciferol)	400 IU
Vitamin E (dl-alpha tocopheryl acetate)	30 IU
Thiamin (Vitamin B1)	3 mg
Riboflavin (Vitamin B2)	3.4 mg
Niacinamide (Vitamin B3)	20 mg
Vitamin B6 (Pyridoxine HCl)	20 mg
Folic Acid	1 mg
Iodine (Potassium iodide)	150 mcg
Zinc (Zinc oxide)	25 mg
Copper (Cupric oxide)	2 mg
Docusate Sodium	50 mg

Each DHA gelatin capsule contains:

Docosahexaenoic Acid

(DHA, 40% from 750 mg Algal Oil)................................... 300 mg

Eicosapentaenoic Acid (EPA) .................. Not more than 0.750 mg

Other ingredients in DHA gelatin capsule: High Oleic Sunflower Oil, Sunflower Lecithin, Rosemary Extract, Tocopherols, Ascorbyl Palmitate.

Section 51945-4

CitraNatal^® 90 DHA Carton

NDC: 0178-0829-30

Storage

Store at 20-25°C (68-77°F)

NOTICE: Contact with moisture can discolor or erode the tablet.

Warning

Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B₁₂ is deficient.

Precautions

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

Indications

CitraNatal^® 90 DHA is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

Structured Label Content

Recent Major Changes (34066-1)

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

Section 51945-4 (51945-4)

CitraNatal^® 90 DHA Carton

NDC: 0178-0829-30

Storage (STORAGE)

Store at 20-25°C (68-77°F)

NOTICE: Contact with moisture can discolor or erode the tablet.

Warning (WARNING)

Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B₁₂ is deficient.

Description (DESCRIPTION)

CitraNatal^® 90 DHA is a prescription prenatal/postnatal multivitamin/mineral tablet with Ferr-Ease^®, a patented dual-iron delivery comprising both a quick release and slow release iron, and a capsule of an essential fatty acid. The prenatal vitamin is a scored, white, oval multivitamin/mineral tablet. The tablet is debossed “CN 90” on one side and “08” bisect “29” on the other. The essential fatty acid DHA capsule is caramel colored and contains a light yellow to orange semi-solid mixture.

Each prenatal tablet contains:

Vitamin C (Ascorbic acid)	120 mg
Calcium (Calcium citrate)	160 mg
Iron (Carbonyl iron, ferrous gluconate)	90 mg
Vitamin D3 (Cholecalciferol)	400 IU
Vitamin E (dl-alpha tocopheryl acetate)	30 IU
Thiamin (Vitamin B1)	3 mg
Riboflavin (Vitamin B2)	3.4 mg
Niacinamide (Vitamin B3)	20 mg
Vitamin B6 (Pyridoxine HCl)	20 mg
Folic Acid	1 mg
Iodine (Potassium iodide)	150 mcg
Zinc (Zinc oxide)	25 mg
Copper (Cupric oxide)	2 mg
Docusate Sodium	50 mg

Each DHA gelatin capsule contains:

Docosahexaenoic Acid

(DHA, 40% from 750 mg Algal Oil)................................... 300 mg

Eicosapentaenoic Acid (EPA) .................. Not more than 0.750 mg

Other ingredients in DHA gelatin capsule: High Oleic Sunflower Oil, Sunflower Lecithin, Rosemary Extract, Tocopherols, Ascorbyl Palmitate.

Precautions (PRECAUTIONS)

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

Indications (indications)

CitraNatal^® 90 DHA is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

How Supplied (HOW SUPPLIED)

Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0829-30

To report a serious adverse event or obtain product information, call (210) 696-8400.

50261

C01 Rev 011110

DHA capsules manufactured for:

MISSION PHARMACAL COMPANY

San Antonio, TX USA 78230 1355

Prenatal tablets manufactured by:

MISSION PHARMACAL COMPANY

San Antonio, TX USA 78230 1355

Adverse Reactions (ADVERSE REACTIONS)

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

Contraindications (CONTRAINDICATIONS)

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

One tablet and one capsule daily or as directed by a physician.

Advanced Ingredient Data

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"mg", "strengthDenominatorUnit": "1"}, {"name": "FERROUS GLUCONATE", "unii": "U1B11I423Z", "classCode": "IACT", "strengthNumerator": "44", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "35.9", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "NIACINAMIDE", "unii": "25X51I8RD4", "classCode": "IACT", "strengthNumerator": "26.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ACRYLIC ACID", "unii": "J94PBK7X8S", "classCode": "IACT", "strengthNumerator": "23.2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, 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Raw Label Data

All Sections (JSON)

{"34066-1": "WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.", "51945-4": "CitraNatal ® 90 DHA Carton NDC: 0178-0829-30", "STORAGE": "Store at 20-25°C (68-77°F) NOTICE: Contact with moisture can discolor or erode the tablet.", "WARNING": "Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis. WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient.", "DESCRIPTION": "CitraNatal ® 90 DHA is a prescription prenatal/postnatal multivitamin/mineral tablet with Ferr-Ease ® , a patented dual-iron delivery comprising both a quick release and slow release iron, and a capsule of an essential fatty acid. The prenatal vitamin is a scored, white, oval multivitamin/mineral tablet. The tablet is debossed “CN 90” on one side and “08” bisect “29” on the other. The essential fatty acid DHA capsule is caramel colored and contains a light yellow to orange semi-solid mixture. Each prenatal tablet contains: Vitamin C (Ascorbic acid) 120 mg Calcium (Calcium citrate) 160 mg Iron (Carbonyl iron, ferrous gluconate) 90 mg Vitamin D3 (Cholecalciferol) 400 IU Vitamin E (dl-alpha tocopheryl acetate) 30 IU Thiamin (Vitamin B1) 3 mg Riboflavin (Vitamin B2) 3.4 mg Niacinamide (Vitamin B3) 20 mg Vitamin B6 (Pyridoxine HCl) 20 mg Folic Acid 1 mg Iodine (Potassium iodide) 150 mcg Zinc (Zinc oxide) 25 mg Copper (Cupric oxide) 2 mg Docusate Sodium 50 mg Each DHA gelatin capsule contains: Docosahexaenoic Acid (DHA, 40% from 750 mg Algal Oil)................................... 300 mg Eicosapentaenoic Acid (EPA) .................. Not more than 0.750 mg Other ingredients in DHA gelatin capsule: High Oleic Sunflower Oil, Sunflower Lecithin, Rosemary Extract, Tocopherols, Ascorbyl Palmitate.", "PRECAUTIONS": "Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.", "indications": "CitraNatal ® 90 DHA is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.", "HOW SUPPLIED": "Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0829-30 To report a serious adverse event or obtain product information, call (210) 696-8400. 50261 C01 Rev 011110 DHA capsules manufactured for: MISSION PHARMACAL COMPANY San Antonio, TX USA 78230 1355 Prenatal tablets manufactured by: MISSION PHARMACAL COMPANY San Antonio, TX USA 78230 1355", "ADVERSE REACTIONS": "Allergic sensitization has been reported following both oral and parenteral administration of folic acid.", "CONTRAINDICATIONS": "This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.", "DOSAGE AND ADMINISTRATION": "One tablet and one capsule daily or as directed by a physician."}