Citranatal Harmony 2.1 Package Insert

Prescribing information (package insert) - Citranatal Harmony 2.1

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.

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 “0797” in white ink.

Each prenatal capsule contains:
Calcium (Calcium citrate)	104 mg	Vitamin B ₆(Pyridoxine HCI)	25 mg
Iron (Carbonyl iron)	29 mg	Folic Acid	1 mg
Vitamin D ₃(Cholecalciferol)	400 \|U	Docusate Sodium	50 mg
Vitamin E (d\|-alpha tocopheryl acetate)	30 \|U	Docosahexaenoic Acid (DHA 40% from 650 mg Algal Oil)	265 mg

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 contraindictated 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 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.

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 0178–0797–30

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

Please consult your health care provider with any dietary concerns.

Manufactured for:

MISSION PHARMACAL COMPANY

San Antonio, TX USA 78230 1355

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 Harmony 2.1

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

Active ingredients

Calcium citrate 104 mg, Iron 29 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
104 mg, 29 mg – 5 in 1 bottle / 1 in 1 carton NDC 0178-0797-05
104 mg, 29 mg – 30 in 1 bottle NDC 0178-0797-30

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.