FDA Label for Inatal Ultra
View Indications, Usage & Precautions
Inatal Ultra Product Label
The following document was submitted to the FDA by the labeler of this product Nnodum Pharmaceuticals. 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:
INATAL Ultra is a white, dye free, oval oil-and-water-soluble multivitamin/multimineral tablet with calcium citrate and carbonyl iron.
Each tablet contains:
Vitamin A* . . . . . . . . . . . . . . . . . . . . . . . 2700 I.U.
Vitamin C (Ascorbic Acid) . . . . . . . . . . . . . . 120 mg
Calcium (Calcium Citrate) . . . . . . . . . . . . . 200 mg
Elemental Iron (Carbonyl Iron) . . . . . . . . . . . 90 mg
Vitamin D3 (Cholecalciferol) . . . . . . . . . . . . 400 I.U.
Vitamin E (dl-Alpha Tocopheryl Acetate) . . . . . 30 I.U.
Vitamin B1 (Thiamine Mononitrate) . . . . . . . . . 3 mg
Vitamin B2 (Riboflavin) . . . . . . . . . . . . . . . . 3.4 mg
Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mg
Vitamin B6 (Pyridoxine HCI) . . . . . . . . . . . . . 20 mg
Folic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 mg
Vitamin B12 (Cyanocobalamin) . . . . . . . . . . 12 mcg
Iodine (Potassium Iodide) . . . . . . . . . . . . . 150 mcg
Zinc (Zinc Oxide) . . . . . . . . . . . . . . . . . . . . . 25 mg
Copper (Cupric Oxide) . . . . . . . . . . . . . . . . . 2 mg
Docusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mg
*Input as Vitamin A palmitate and beta carotene.
Indications:
INATAL Ultra ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Ultra NatalCare® can also be beneficial in improving the nutritional status of women prior to conception.
Contraindications:
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Warnings:
Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
NOTICE: Contact with moisture may produce surface discoloration or erosion of the tablet.
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.
Pediatric Use:
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use:
Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Dosage And Administration:
One tablet daily or as directed by a physician.
How Supplied:
NDC 63044-154-63 Unit Dose Packs containing 10 tablets per card.
Store at controlled room temperature 15°-30°C (59°-86°F).
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Manufactured for
Nnodum Pharmaceutical
Cincinnati, Ohio 45229
* Please review the disclaimer below.