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CitraNatal DHA Package Insert

Status:
Prescription (Rx) Boxed warning Facts
Strength:
120 mg, 400 IU, 27 mg, 30 IU, 3 mg, 3.4 mg, 20 mg, 20 mg, 1 mg, 150 mg, 25 mg, 2 mg, 50 mg, 124 mg, 250 mg, 0.625 mg
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - CitraNatal DHA

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.

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.

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

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.

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 B 12 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 soft gel daily or as directed by a physician.

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.

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.

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for CitraNatal DHA

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Blood Coagulation Factor, Phosphate Binder, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Ascorbic acid 120 mg, Vitamin D 400 IU, Iron 27 mg, Alpha-tocopherol acetate 30 IU, Thiamine 3 mg, Riboflavin 3.4 mg, Niacinamide 20 mg, Pyridoxine hydrochloride 20 mg, Folic acid 1 mg, Potassium iodide 150 mg, Zinc oxide 25 mg, Cupric oxide 2 mg, Docusate sodium 50 mg, Calcium citrate 124 mg, Doconexent 250 mg, Icosapent 0.625 mg
Dosage form Kit
Marketing status not in the current FDA NDC Directory
Company (applicant) Mission Pharmacal Company
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
120 mg, 400 IU, 27 mg, 30 IU, 3 mg, 3.4 mg, 20 mg, 20 mg, 1 mg, 150 mg, 25 mg, 2 mg, 50 mg, 124 mg, 250 mg, 0.625 mg – 1 in 1 blister pack / 30 in 1 carton NDC 0178-0894-30

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.