Inatal Advance
FDA Label NDC 63044-153

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nnodum Pharmaceuticals for the product Inatal Advance (NDC 63044-153). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, indications:, contraindications:, warnings:, precautions:, pediatric use:, geriatric use:, dosage and administration:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Description

INATAL Advanced ® is a white, dye-free, oval shaped, oil-and-water soluble multivitamin/multimineral tablet which contains calcium carbonate and carbonyl iron.

Each tablet contains:

Vitamin A (as beta-carotene) . . . . . . . . . . . 2700 I.U.

Vitamin C (ascorbic acid) . . . . . . . . . . . . . . 120 mg

Calcium (as calcium carbonate) . . . . . . . . . . 200 mg

Elemental Iron (as carbonyl iron) . . . . . . . . . . 90 mg

Vitamin D3 (cholecalciferol) . . . . . . . . . . . . 400 I.U.

Vitamin E (dl-alpha tocopheryl acetate) . . . . . 30 I.U.

Vitamin B1 (as thiamine mononitrate) . . . . . . . . 3 mg

Vitamin B2 (riboflavin, USP) . . . . . . . . . . . . . 3.4 mg

Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mg

Vitamin B6 (as pyridoxine HCI, USP) . . . . . . . 20 mg

Folic Acid, USP . . . . . . . . . . . . . . . . . . . . . . . 1 mg

Vitamin B12 (cyanocobalamin) . . . . . . . . . . . 12 mcg

Zinc (as zinc oxide, USP) . . . . . . . . . . . . . . . . 25 mg

Copper (as cupric oxide) . . . . . . . . . . . . . . . . . 2 mg

Magnesium (as magnesium oxide, USP) . . . . . 30 mg

Docusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mg

INACTIVE INGREDIENTS: Carnauba wax, crospovidone, ethyl vanillin, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, silicon dioxide, stearic acid, and titanium dioxide

Indications:

INATAL ADVANCE ® 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. INATAL Advanced® 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 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

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 staring 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 63044-153-64 Unit Dose Packs of 90’s with each blister card 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 Pharmaceuticals
Cincinnati, Ohio 45229

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