Medication-info.com Search Menu

CitraNatal Harmony Package Insert

Status:
Prescription (Rx) Boxed warning Facts
Strength:
100 mg, 28 mg, 400 IU, 30 IU, 25 mg, 1 mg, 50 mg, 250 mg
Drug class:
Active ingredients:
Similar drugs:

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

Prescribing information (package insert) - CitraNatal Harmony

DESCRIPTION

CitraNatal Harmony® is a prescription prenatal/postnatal multivitamin/mineral soft gelatin capsule. The prenatal vitamin is a purple, opaque soft gelatin capsule containing a greenish-gray liquid to semi-solid fill. The capsule is printed "0799" in white ink.

Each prenatal capsule contains:

Calcium (Calcium citrate)100 mgVitamin B6 (Pyridoxine HCl)25 mg
Iron (Carbonyl iron)28 mgFolic Acid1 mg
Vitamin D3 (Cholecalciferol)400 IUDocusate Sodium50 mg
Vitamin E (dl-alpha tocopheryl acetate)30 IUDocosahexaenoic Acid (DHA)250 mg

DHA is contained in the oil derived from microalgae.

INDICATIONS

CitraNatal Harmony® 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-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.

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.

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

DOSAGE AND ADMINISTRATION

One capsule daily or as directed by a physician.

Store at controlled room temperature.

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

HOW SUPPLIED

Bottles of 30 capsules each - NDC 0178-0799-30.

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

life'sDHA™

Trademark of Martek Biosciences Corporation

U.S. Patent No. 5,407,857

U.S. Patent No. 5,492,938

*March of Dimes does not endorse specific products or brands. March of Dimes is a registered trademark of the March of Dimes Foundation.

Manufactured for:

MISSION PHARMACAL COMPANY

San Antonio, TX USA 78230 1355

www.missionpharmacal.com

Copyright © 2011 Mission Pharmacal Company. All rights reserved.

About this document

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

Found a mistake? Write to us via the contact page.

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

Drug information for CitraNatal Harmony

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 Calcium, Vitamin B6 Analog, Vitamin D
Active ingredients Calcium citrate 100 mg, Iron pentacarbonyl 28 mg, Cholecalciferol 400 IU, Alpha-tocopherol, DL- 30 IU, Pyridoxine hydrochloride 25 mg, Folic acid 1 mg, Docusate sodium 50 mg, Doconexent 250 mg
Dosage form Capsule, gelatin coated
Route Oral
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
100 mg, 28 mg, 400 IU, 30 IU, 25 mg, 1 mg, 50 mg, 250 mg – 5 in 1 bottle / 1 in 1 carton NDC 0178-0799-05
100 mg, 28 mg, 400 IU, 30 IU, 25 mg, 1 mg, 50 mg, 250 mg – 30 in 1 bottle / 1 in 1 carton NDC 0178-0799-30

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.