PrimaCare ONE

A once-daily prenatal vitamin supplement, including key omega-3 fatty acids (DHA and EPA) and 1 mg folic acid

What is PrimaCare ONE?

PrimaCare ONE is a prescription prenatal/postnatal multivitamin/mineral capsule with essential fatty acids.

Each purple soft gelatin capsule for oral administration contains:

Essential Fatty Acids and Precursors:
Omega-3 Fatty Acids 300 mg
Linoleic Acid 30 mg
Linolenic Acid 30 mg
Vitamins:
Vitamin C (as Ester-C )* 25 mg
Vitamin D3 (cholecalciferol) 170 IU
Vitamin E (dl-alpha-tocopheryl acetate) 30 IU
Folic Acid, USP 1 mg
Vitamin B6 (pyridoxine hydrochloride) 25 mg
Minerals:
Calcium 150 mg
Iron (carbonyl iron) 27 mg

*Ester-C is a patented pharmaceutical grade material consisting of calcium ascorbate and calcium threonate.

Inactive Ingredients:
D&C Red No. 33, ethylvanillin, FD&C Blue No. 1, gelatin, glycerine, hydrogenated vegetable oil, lecithin, methylparaben, propylparaben, soybean oil, titanium dioxide, vegetable shortening, and yellow beeswax.

PrimaCare ONE Indications

PrimaCare ONE is indicated to provide vitamin/mineral and essential fatty acid supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. It is also useful for improving nutritional status prior to conception.

PrimaCare ONE Contraindications

PrimaCare ONE is contraindicated in patients with a known hypersensitivity to any of the ingredients.

PrimaCare ONE Warnings

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

PrimaCare ONE Precautions

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: Clinical studies on this product have not been performed 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.

PrimaCare ONE Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

PrimaCare ONE Dosage and Administration

Usual dosage is one capsule daily, or as prescribed by a physician.

How Supplied

PrimaCare ONE prenatal/postnatal multivitamin/mineral capsules are purple soft gelatin capsules, imprinted "Ther-Rx 142" in white ink, packaged in bottles of 30 capsules (NDC 64011-142-19).

Store at controlled room temperature 15° - 30° C (59° - 86° F).

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

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