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CitraNatal Harmony 3.0: Package Insert / Prescribing Info

Package insert / product label
Generic name: calcium citrate, iron, cholecalciferol, .alpha.-tocopherol, pyridoxine, folic acid, docusate sodium and doconexent
Dosage form: capsule, gelatin
Drug classes: Iron products, Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Oct 23, 2024.

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.

CitraNatal Harmony 3.0 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 “0796” in white ink.

Each prenatal capsule contains:
Calcium (Calcium citrate)104 mgVitamin B 6 (Pyridoxine HCl)    25    mg
Iron (Ferrous fumarate, carbonyl iron)   27 mgFolic Acid      1    mg
Vitamin D 3 (Cholecalciferol) 400 IUDocusate Sodium   50    mg
Vitamin E (dl-alpha tocopheryl acetate)   30 IUDocosahexaenoic Acid (DHA 40% from 650 mg Algal Oil)260    mg

Indications and Usage for CitraNatal Harmony 3.0

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.

Warnings

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/Side Effects

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.

CitraNatal Harmony 3.0 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 is CitraNatal Harmony 3.0 supplied

Bottles of 30 capsules each - NDC 0178-0796-30

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


CitraNatal Label

NDC 0178-0796-30

Label

CITRANATAL HARMONY 3.0
calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, docusate sodium, and doconexent capsule, gelatin coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0178-0796
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE ANHYDROUS104 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON27 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL30 [iU]
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE25 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT260 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)
Product Characteristics
Colorpurple (opaque) Scoreno score
ShapeCAPSULESize25mm
FlavorImprint Code0796
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0178-0796-3030 in 1 BOTTLE; Type 0: Not a Combination Product03/21/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/21/2014
Labeler - Mission Pharmacal Company (008117095)
Registrant - Mission Pharmacal Company (927726893)