Citranatal Assure ®

Citranatal Assure ®
SPL v11
SPL
SPL Set ID 06c529fc-272c-f889-f5e5-7f3e5ef2c59d
Route
ORAL
Published
Effective Date 2020-11-01
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ascorbic Acid (120 mg) Iron (35 mg) Cholecalciferol (400 [iU]) Alpha-tocopherol (30 [iU]) Riboflavin (3.4 mg) Niacinamide (20 mg) Pyridoxine (25 mg) Folic Acid (1 mg) Iodine (150 ug) Zinc (2 mg) Copper (50 mg) Docusate (3 mg) Thiamine Ion (124 mg) Doconexent (300 mg) Icosapent (0.75 mg)
Inactive Ingredients
Povidone K30 Croscarmellose Sodium Titanium Dioxide Magnesium Silicate Magnesium Stearate Shellac Vanillin Gelatin Sunflower Oil Glycerin Lecithin, Sunflower Rosemary Tocopherol Ascorbyl Palmitate

Identifiers & Packaging

Pill Appearance
Imprint: 0891 Shape: oval Shape: capsule Color: white Color: orange Size: 20 mm Size: 23 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2014-04-30

Description

CitraNatal Assure ® 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 white, coated, oval multivitamin/mineral tablet. The tablet is debossed "0891" on one side and is blank on the other. The essential fatty acid DHA capsule is caramel colored and contains a light yellow to orange semi-solid mixture. Each prenatal capsule contains: Vitamin C (Ascorbic acid) 120   mg Calcium (Calcium citrate) 124 mg Iron (Carbonyl iron, ferrous gluconate) 35   mg Vitamin D 3 (Cholecalciferol) 400   IU Vitamin E (dl-alpha tocopheryl acetate) 30   IU Thiamin (Vitamin B 1 ) 3   mg Riboflavin (Vitamin B 2 ) 3.4   mg Niacinamide (Vitamin B 3 ) 20   mg Vitamin B 6 (Pyridoxine HCl) 25   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: Gelatin, sunflower oil, glycerin, caramel color, sunflower lecithin, rosemary extract, tocopherols, ascorbyl palmitate.

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.


Medication Information

Dosage and Administration

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

Dosage Forms and Strengths

Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0891-30

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.

Description

CitraNatal Assure ®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 white, coated, oval multivitamin/mineral tablet. The tablet is debossed "0891" on one side and is blank on the other. The essential fatty acid DHA capsule is caramel colored and contains a light yellow to orange semi-solid mixture.

Each prenatal capsule contains:
Vitamin C (Ascorbic acid) 120   mg
Calcium (Calcium citrate) 124 mg
Iron (Carbonyl iron, ferrous gluconate) 35   mg
Vitamin D 3(Cholecalciferol) 400   IU
Vitamin E (dl-alpha tocopheryl acetate) 30   IU
Thiamin (Vitamin B 1) 3   mg
Riboflavin (Vitamin B 2) 3.4   mg
Niacinamide (Vitamin B 3) 20   mg
Vitamin B 6(Pyridoxine HCl) 25   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: Gelatin, sunflower oil, glycerin, caramel color, sunflower lecithin, rosemary extract, tocopherols, ascorbyl palmitate.

Notice

Contact with moisture can discolor or erode the tablet.

Section 42229-5

CAUTION: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

Section 51945-4

CitraNatal Assure Retail Blister Pack

NDC 0178–0891–30

Storage

Store at 20–25°C (68–77°F)

Warning

Accidental overdose of iron-containingproducts 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.

Indications

CitraNatal Assure ®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.

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

Notice (NOTICE)

Contact with moisture can discolor or erode the tablet.

Dosage Forms and Strengths (34069-5)

Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0891-30

Section 42229-5 (42229-5)

CAUTION: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

Section 51945-4 (51945-4)

CitraNatal Assure Retail Blister Pack

NDC 0178–0891–30

Storage (STORAGE)

Store at 20–25°C (68–77°F)

Warning (WARNING)

Accidental overdose of iron-containingproducts 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.

Description (DESCRIPTION)

CitraNatal Assure ®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 white, coated, oval multivitamin/mineral tablet. The tablet is debossed "0891" on one side and is blank on the other. The essential fatty acid DHA capsule is caramel colored and contains a light yellow to orange semi-solid mixture.

Each prenatal capsule contains:
Vitamin C (Ascorbic acid) 120   mg
Calcium (Calcium citrate) 124 mg
Iron (Carbonyl iron, ferrous gluconate) 35   mg
Vitamin D 3(Cholecalciferol) 400   IU
Vitamin E (dl-alpha tocopheryl acetate) 30   IU
Thiamin (Vitamin B 1) 3   mg
Riboflavin (Vitamin B 2) 3.4   mg
Niacinamide (Vitamin B 3) 20   mg
Vitamin B 6(Pyridoxine HCl) 25   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: Gelatin, sunflower oil, glycerin, caramel color, sunflower lecithin, rosemary extract, tocopherols, ascorbyl palmitate.

Indications (INDICATIONS)

CitraNatal Assure ®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.

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.

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


Raw Label Data

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