FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
® is a prescription prenatal/postnatal multivitamin/mineral tablet
®, 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
|Each prenatal capsule contains:|
|Vitamin C (Ascorbic acid)||120 ||mg|
|Calcium (Calcium citrate)||124||mg|
|Iron (Carbonyl iron, ferrous gluconate)||35 ||mg|
|Vitamin E (dl-alpha tocopheryl acetate)||30 ||IU|
|Thiamin (Vitamin B
|Riboflavin (Vitamin B
|Niacinamide (Vitamin B
6 (Pyridoxine HCl)
|Folic Acid||1 ||mg|
|Iodine (Potassium iodide)||150 ||mcg|
|Zinc (Zinc oxide)||25 ||mg|
|Copper (Cupric oxide)||2 ||mg|
|Docusate Sodium||50 ||mg|
|Each DHA gelatin capsule contains:|
|Docosahexaenoic Acid (DHA, 40% from 750 mg Algal Oil)||300 ||mg|
|Eicosapentaenoic Acid (EPA)||Not more than 0.750 ||mg|
Other ingredients in DHA
gelatin capsule: Gelatin, sunflower oil, glycerin, caramel color,
sunflower lecithin, rosemary extract, tocopherols, ascorbyl palmitate.
® 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.
This product is contraindicated in patients
with a known hypersensitivity to any of the ingredients.
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 B
12 is deficient.
Folic acid in doses above 0.1
mg daily may obscure pernicious anemia in that hematologic remission
can occur while neurological manifestations progress.
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.
at 20–25°C (68–77°F)
Contact with moisture can discolor
or erode the tablet.
To report a serious adverse event or obtain product information,
call (210) 696-8400.
C01 Rev 010130
DHA capsules manufactured for:
San Antonio, TX USA 78230 1355
Prenatal tablets manufactured by:
San Antonio, TX USA 78230 1355
Copyright © 2013
Mission Pharmacal Company.
All rights reserved.
Trademark of Mission Pharmacal Company
U.S. Patent No. 6,521,247
is a trademark of DSM.
U.S. Patent No. 7,579,174
U.S. Patent No. 7,732,170
U.S. Patent No. 5,518,918
*March of Dimes does
specific products or brands.
of Dimes is a registered trademark
of the March of Dimes
Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0891-30
Package Label.Principal Display Panel
Assure Sample Blister Pack
Sample Pack Display
Assure Retail Blister Pack
* Please review the disclaimer below.