CitraNatal DHA description, usages, side effects, indications, overdosage, supplying and lots more!

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CitraNatal DHA

Mission Pharmacal Company
Mission Pharmacal Company

CitraNatal DHA


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

CITRANATAL DHA DESCRIPTION

CitraNatal® 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, scored, oval multivitamin/mineral tablet. The tablet is debossed “CN RX” 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 tablet contains:
Vitamin C (Ascorbic acid) 120 mg
Calcium (Calcium citrate) 125 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 gelatin capsule contains:
Docosahexaenoic Acid ((DHA, 40% from 625 mg Algal Oil) 250 mg Eicosapentaenoic Acid (EPA)................. Not more than 0.625 mg Other ingredients in DHA gelatin capsule: High Oleic Sunflower Oil, Sunflower Lecithin, Rosemary Extract, Tocopherols, Ascorbyl Palmitate.

Active ingredient

Purpose

INDICATIONS

[Insert Clinical Pharmacology General text here]

CONTRAINDICATIONS

[Insert Mechanism of Action text here]

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.

CITRANATAL DHA ADVERSE REACTIONS

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

CITRANATAL DHA DOSAGE AND ADMINISTRATION

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

STORAGE

Store at 20-25°C (68-77°F)

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

HOW SUPPLIED

Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0898-30

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

500238

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

CitraNatal® DHA Carton
NDC: 0178-0898-30

CitraNatal DHA

CitraNatal DHA

Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Thiamin, Riboflavin, Niacinamide, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0178-0898
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ASCORBIC ACID ASCORBIC ACID 120 mg
CALCIUM CITRATE CALCIUM CATION 125 mg
IRON IRON 27 mg
Vitamin D 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE 30 [iU]
Thiamine 3 mg
RIBOFLAVIN RIBOFLAVIN 3.4 mg
NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 20 mg
FOLIC ACID FOLIC ACID 1 mg
Potassium Iodide IODIDE ION 150 mg
Zinc Oxide Zinc oxide 25 mg
CUPRIC OXIDE CUPRIC CATION 2 mg
DOCUSATE SODIUM DOCUSATE 50 mg

Inactive Ingredients

Ingredient Name Strength
POVIDONES
CROSCARMELLOSE SODIUM
titanium dioxide
NIACINAMIDE
magnesium silicate
THIAMINE MONONITRATE
SHELLAC
POLYETHYLENE GLYCOLS
ETHYL VANILLIN
VITAMIN A PALMITATE
Vitamin D

Product Characteristics

Color Size Imprint Code Shape
BROWN (caramel) 10 mm CN;RX CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 BLISTER PACK
2 5 in 1 BLISTER PACK
3 NDC:0178-0898-30 6 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2007-11-20


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