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CitraNatal Assure Package Insert

Status:
Prescription (Rx) Boxed warning Facts
Strength:
120 mg, 35 mg, 400 IU, 30 IU, 3.4 mg, 20 mg, 25 mg, 1 mg, 150 mcg, 25 mg, 2 mg, 50 mg, 3 mg, 124 mg, 300 mg, 0.75 mg
Drug class:
Active ingredients:
Similar drugs:

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

Prescribing information (package insert) - CitraNatal Assure

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)120mg
Calcium (Calcium citrate)124mg
Iron (Carbonyl iron, ferrous gluconate)35mg
Vitamin D 3(Cholecalciferol)400IU
Vitamin E (dl-alpha tocopheryl acetate)30IU
Thiamin (Vitamin B 1)3mg
Riboflavin (Vitamin B 2)3.4mg
Niacinamide (Vitamin B 3)20mg
Vitamin B 6(Pyridoxine HCl)25mg
Folic Acid1mg
Iodine (Potassium iodide)150mcg
Zinc (Zinc oxide)25mg
Copper (Cupric oxide)2mg
Docusate Sodium50mg
Each DHA gelatin capsule contains:
Docosahexaenoic Acid (DHA, 40% from 750 mg Algal Oil)300mg
Eicosapentaenoic Acid (EPA)Not more than 0.750mg

Other ingredients in DHA gelatin capsule: Gelatin, sunflower oil, glycerin, caramel color, sunflower lecithin, rosemary extract, tocopherols, ascorbyl palmitate.

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.

CONTRAINDICATIONS

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

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.

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.

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.

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

STORAGE

Store at 20–25°C (68–77°F)

NOTICE

Contact with moisture can discolor or erode the tablet.

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

51062R1120

MISSION ®PHARMACAL

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

Copyright © 2020 Mission Pharmacal Company.

All rights reserved.

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

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 Assure

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, Copper-containing Intrauterine Device, Phosphate Binder, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Ascorbic acid 120 mg, Iron 35 mg, Cholecalciferol 400 IU, Alpha-tocopherol 30 IU, Riboflavin 3.4 mg, Niacinamide 20 mg, Pyridoxine hydrochloride 25 mg, Folic acid 1 mg, Iodine 150 mcg, Zinc 25 mg, Copper 2 mg, Docusate sodium 50 mg, Thiamine 3 mg, Calcium citrate 124 mg, Doconexent 300 mg, Icosapent 0.75 mg
Dosage form Kit
Marketing status listed in the 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, 35 mg, 400 IU, 30 IU, 3.4 mg, 20 mg, 25 mg, 1 mg, 150 mcg, 25 mg, 2 mg, 50 mg, 3 mg, 124 mg, 300 mg, 0.75 mg – 1 in 1 blister pack / 30 in 1 carton NDC 0178-0891-30

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.