Citranatal ®

Drug Facts

Composition & Product

Active Ingredients

Ascorbic Acid (120 mg) Cholecalciferol (400 [iU]) Iron (27 mg) .alpha.-tocopherol (30 [iU]) Thiamine Ion (3 mg) Riboflavin (3.4 mg) Niacinamide (20 mg) Pyridoxine (1 mg) Folic Acid (150 mg) Iodide Ion (25 mg) Zinc Oxide (2 mg) Cupric Cation (50 mg) Docusate (124 mg) Doconexent (250 mg) Icosapent (0.625 mg)

Inactive Ingredients

Croscarmellose Sodium Titanium Dioxide Magnesium Silicate Shellac Ethyl Vanillin Vitamin A Palmitate Sunflower Oil Lecithin, Sunflower Rosemary Tocopherol Ascorbyl Palmitate

Identifiers & Packaging

Pill Appearance

Imprint: CN;1 Shape: oval Shape: capsule Color: white Color: brown Size: 20 mm Size: 23 mm Score: 1

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2014-05-22

Medication Information

Recent Major Changes

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.

Warnings and Precautions

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.

Dosage and Administration

One tablet and one soft gel 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 soft gels each - NDC 0178-0894-30.

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

Please consult your health care provider with any dietary concerns.

500243

C01 Rev 002140

DHA soft gels 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 ^® DHA is a prescription prenatal/postnatal multi-vitamin/mineral tablet with Ferr-Ease ^®, a patented dual-iron delivery comprising both a quick release and slow release iron, and a soft gel of an essential fatty acid. The prenatal vitamin is a white, scored, oval multi-vitamin/mineral tablet. The tablet is debossed “CN 1” on one side and is blank on the other. The essential fatty acid DHA soft gel is caramel colored and contains a light yellow to orange semi-solid mixture.

Section 51945-4

Citranatal DHA

Rx Prenatal Vitamin Tablet

and 250 mg DHA Soft Gel

Carton

NDC 0178–0894–30

Section 55106-9

Each prenatal tablet contains:

Vitamin C (Ascorbic acid)	120 mg
Calcium (Calcium citrate)	124 mg
Iron (Carbonyl iron, ferrous gluconate)	27 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)	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 soft gel contains:

Other ingredients in DHA soft gel: High oleic sunflower oil, sunflower lecithin, rosemary extract, tocopherols, ascorbyl palmitate.
Docosahexaenoic Acid (DHA, 40% from 625 mg Algal Oil)	250 mg
Eicosapentaenoic Acid (EPA)	Not more than 0.625 mg

Storage

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimalized.

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

Indications

CitraNatal ^® DHA is a multi-vitamin/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.

Precautions

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

Structured Label Content

Recent Major Changes (34066-1)

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.

Warnings and Precautions (34071-1)

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.

Section 51945-4 (51945-4)

Citranatal DHA

Rx Prenatal Vitamin Tablet

and 250 mg DHA Soft Gel

Carton

NDC 0178–0894–30

Section 55106-9 (55106-9)

Each prenatal tablet contains:

Vitamin C (Ascorbic acid)	120 mg
Calcium (Calcium citrate)	124 mg
Iron (Carbonyl iron, ferrous gluconate)	27 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)	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 soft gel contains:

Other ingredients in DHA soft gel: High oleic sunflower oil, sunflower lecithin, rosemary extract, tocopherols, ascorbyl palmitate.
Docosahexaenoic Acid (DHA, 40% from 625 mg Algal Oil)	250 mg
Eicosapentaenoic Acid (EPA)	Not more than 0.625 mg

Storage (STORAGE)

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimalized.

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

Description (DESCRIPTION)

CitraNatal ^® DHA is a prescription prenatal/postnatal multi-vitamin/mineral tablet with Ferr-Ease ^®, a patented dual-iron delivery comprising both a quick release and slow release iron, and a soft gel of an essential fatty acid. The prenatal vitamin is a white, scored, oval multi-vitamin/mineral tablet. The tablet is debossed “CN 1” on one side and is blank on the other. The essential fatty acid DHA soft gel is caramel colored and contains a light yellow to orange semi-solid mixture.

Indications (INDICATIONS)

CitraNatal ^® DHA is a multi-vitamin/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.

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.

How Supplied (HOW SUPPLIED)

Six child-resistant blister packs of 5 tablets and 5 soft gels each - NDC 0178-0894-30.

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

Please consult your health care provider with any dietary concerns.

500243

C01 Rev 002140

DHA soft gels 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 soft gel daily or as directed by a physician.

Advanced Ingredient Data

[{"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM SILICATE", "unii": "9B9691B2N9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHELLAC", "unii": "46N107B71O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYL VANILLIN", "unii": "YC9ST449YJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "VITAMIN A PALMITATE", "unii": "1D1K0N0VVC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASCORBIC ACID", "unii": "PQ6CK8PD0R", "classCode": "ACTIB", "strengthNumerator": "120", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CHOLECALCIFEROL", "unii": "1C6V77QF41", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "[iU]", "strengthDenominatorUnit": "1"}, {"name": "IRON", "unii": "E1UOL152H7", "classCode": "ACTIB", "strengthNumerator": "27", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "ACTIM", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[iU]", "strengthDenominatorUnit": "1"}, {"name": "THIAMINE ION", "unii": "4ABT0J945J", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "RIBOFLAVIN", "unii": "TLM2976OFR", "classCode": "ACTIB", "strengthNumerator": "3.4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "NIACINAMIDE", "unii": "25X51I8RD4", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PYRIDOXINE", "unii": "KV2JZ1BI6Z", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FOLIC ACID", "unii": "935E97BOY8", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "IODIDE ION", "unii": "09G4I6V86Q", "classCode": "ACTIB", "strengthNumerator": "150", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CUPRIC CATION", "unii": "8CBV67279L", "classCode": "ACTIM", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CALCIUM CITRATE", "unii": "MLM29U2X85", "classCode": "ACTIR", "strengthNumerator": "124", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SUNFLOWER OIL", "unii": "3W1JG795YI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LECITHIN, SUNFLOWER", "unii": "834K0WOS5G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ROSEMARY", "unii": "IJ67X351P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASCORBYL PALMITATE", "unii": "QN83US2B0N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DOCONEXENT", "unii": "ZAD9OKH9JC", "classCode": "ACTIB", "strengthNumerator": "250", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ICOSAPENT", "unii": "AAN7QOV9EA", "classCode": "ACTIB", "strengthNumerator": "0.625", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34066-1": "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.", "34071-1": "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.", "51945-4": "Citranatal DHA Rx Prenatal Vitamin Tablet and 250 mg DHA Soft Gel Carton NDC 0178–0894–30", "55106-9": "Each prenatal tablet contains: Vitamin C (Ascorbic acid) 120 mg Calcium (Calcium citrate) 124 mg Iron (Carbonyl iron, ferrous gluconate) 27 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) 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 soft gel contains: Other ingredients in DHA soft gel: High oleic sunflower oil, sunflower lecithin, rosemary extract, tocopherols, ascorbyl palmitate. Docosahexaenoic Acid (DHA, 40% from 625 mg Algal Oil) 250 mg Eicosapentaenoic Acid (EPA) Not more than 0.625 mg", "STORAGE": "Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimalized. NOTICE: Contact with moisture can discolor or erode the tablet.", "DESCRIPTION": "CitraNatal ® DHA is a prescription prenatal/postnatal multi-vitamin/mineral tablet with Ferr-Ease ® , a patented dual-iron delivery comprising both a quick release and slow release iron, and a soft gel of an essential fatty acid. The prenatal vitamin is a white, scored, oval multi-vitamin/mineral tablet. The tablet is debossed “CN 1” on one side and is blank on the other. The essential fatty acid DHA soft gel is caramel colored and contains a light yellow to orange semi-solid mixture.", "INDICATIONS": "CitraNatal ® DHA is a multi-vitamin/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.", "PRECAUTIONS": "Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.", "HOW SUPPLIED": "Six child-resistant blister packs of 5 tablets and 5 soft gels each - NDC 0178-0894-30. To report a serious adverse event or obtain product information, call (210) 696-8400. Please consult your health care provider with any dietary concerns. 500243 C01 Rev 002140 DHA soft gels manufactured for: MISSION PHARMACAL COMPANY San Antonio, TX USA 78230 1355 Prenatal tablets manufactured by: MISSION PHARMACAL COMPANY San Antonio, TX USA 78230 1355 Copyright © 2014 Mission Pharmacal Company. All rights reserved.", "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 soft gel daily or as directed by a physician."}