Citranatal ®

Citranatal ®
SPL v9
SPL
SPL Set ID 81e639d7-352e-4eaa-87d9-582da68b9728
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 (85 mg) .alpha.-tocopherol (30 [iU]) Thiamine Ion (3 mg) Niacinamide (20 mg) Pyridoxine (1 mg) Folic Acid (25 mg) Zinc Oxide (2 mg) Cupric Cation (50 mg) Docusate (159 mg) Iodide Ion (4.54 mg) Ferrous Cation (150 ug) Vitamin D (5 mg) Riboflavin (400 [iU])

Identifiers & Packaging

Pill Appearance
Imprint: CN;90;0821 Shape: capsule Color: brown Size: 10 mm Score: 2
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2014-04-11

Description

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 0178-0821-30 To report a serious adverse event or obtain product information, call (210) 696-8400. Please consult your health care provider with any dietary concerns. 51072R1120 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 Ferr-Ease™ Dual-iron delivery Trademark of Mission Pharmacal Company


Medication Information

Recent Major Changes

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.

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 - NDC0178-0821-30

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

Please consultyour health care provider with any dietary concerns.

51072R1120

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

Ferr-Ease™



Dual-iron delivery

Trademark of Mission Pharmacal Company

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 white, oval multivitamin/mineral tablet. The tablet is debossed “CN 90” on one side and “0821” 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) 159 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: Gelatin, glycerin, sunflower oil, water, caramel color, tocopherols, rosemary extract, sunflower lecithin, ascorbyl palmitate.

Section 51945-4

CitraNatal ® 90DHA Carton



NDC: 0178-0821-30

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 12is deficient.

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.

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)

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.

Section 51945-4 (51945-4)

CitraNatal ® 90DHA Carton



NDC: 0178-0821-30

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 B 12is 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 white, oval multivitamin/mineral tablet. The tablet is debossed “CN 90” on one side and “0821” 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) 159 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: Gelatin, glycerin, sunflower oil, water, caramel color, tocopherols, rosemary extract, sunflower lecithin, ascorbyl palmitate.

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.

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 capsules each - NDC0178-0821-30

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

Please consultyour health care provider with any dietary concerns.

51072R1120

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

Ferr-Ease™



Dual-iron delivery

Trademark of Mission Pharmacal Company

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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