Citranatal 90 Dha Tablet
FDA Label NDC 0178-0821

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mission Pharmacal Company for the product Citranatal 90 Dha (NDC 0178-0821). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, indications, contraindications, warning, precautions, adverse reactions, dosage and administration, storage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 Acid1 mg
Iodine (Potassium iodide)150 mcg
Zinc (Zinc oxide)25 mg
Copper (Cupric oxide)2 mg
Docusate Sodium50 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

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.

Contraindications

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

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.

Adverse Reactions

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

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 0178-0821-30

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

Please consult your health care provider with any dietary concerns.



51072

C01 Rev 011130


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
U.S. Patent No. 6,521,247

life's DHA™
HEALTHY BRAIN, EYES, HEART

Package Label.Principal Display Panel


CitraNatal®90 DHA Carton
NDC: 0178-0821-30

Citranatal-90-dha-carton (Citranatal 90 Dha Carton)

Citranatal-90-dha-carton (Citranatal 90 Dha Carton)

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