FDA Label for Citranatal Harmony
View Indications, Usage & Precautions
Citranatal Harmony Product Label
The following document was submitted to the FDA by the labeler of this product Mission Pharmacal Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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 "0812" in white ink.
Each prenatal capsule contains:
| Calcium (Calcium citrate) | 100 mg | Vitamin B6 (Pyridoxine HCl) | 25 mg | |
| Iron (Carbonyl iron) | 27 mg | Folic Acid | 1 mg | |
| Vitamin D3 (Cholecalciferol) | 400 IU | Docusate Sodium | 50 mg | |
| Vitamin E (dl-alpha tocopheryl acetate) | 30 IU | Docosahexaenoic 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.
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.
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 0178-0812-30.
Other
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. 5,407,957
U.S. Patent No. 5,492,938
Manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355
www.missionpharmacal.com
Copyright © 2009 Mission Pharmacal Company. All rights reserved.
Principal Display Panel - 30 Capsule Bottle Carton
The one-pill solution
for gentle prenatal nutrition
Rx Only
NDC 0178-0812-05
CitraNatal® Harmony™
Rx Prenatal Vitamin Gel Cap
- Convenient, one-dose prenatal nutrition
in a vanilla-scented gel cap
- Gentle calcium citrate and carbonyl iron,
plus a stool softener and natural,
plant-based DHA
life'sDHA ™
HEALTHY BRAIN, EYES, HEART
5-DAY STARTER PACK
In Child-Resistant Packaging
Sample-Not For Sale
Contains
Stool Softener
Mission®
PHARMACAL
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