PrimaCare

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 5/10/2022
Drug Description

What is PrimaCare and how is it used?

PrimaCare is a prescription medicine used as a multivitamin to prevent vitamin deficiency before, during and after Pregnancy. PrimaCare may be used alone or with other medications.

PrimaCare belongs to a class of drugs called Iron Products; Vitamin and Mineral Combination.

It is not known if PrimaCare is safe and effective in children.

What are the possible side effects of PrimaCare?

PrimaCare may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • easy bruising,
  • unusual bleeding,
  • rash,
  • itching, and
  • severe dizziness

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of PrimaCare include:

  • constipation,
  • diarrhea,
  • upset stomach,
  • nausea, and
  • vomiting

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of PrimaCare. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

DESCRIPTION

PrimaCare®ONE is a prescription prenatal/ postnatal multivitamin/mineral capsule with omega-3 fatty acids. Each purple soft gelatin capsule for oral administration contains:

Essential Fatty Acids:

Omega-3 Fatty Acids....................330 mg
Docosahexaenoic Acid (DHA) ............260 mg
Eicosapentaenoic Acid (EPA) ..............40 mg
a-Linolenic Acid (ALA)...................30 mg
Linoleic Acid...........................30 mg

Vitamins:

Vitamin C (as Ester-C®*) ..................25 mg
Vitamin D3 (cholecalciferol)................170IU
Vitamin E (dl-alpha-tocopheryl acetate).........30IU
Folic Acid, USP..........................1 mg
Vitamin B6 (pyridoxine hydrochloride).........25 mg

Minerals:

Calcium.............................150 mg
Iron
  Carbonyl iron (elemental iron) .............20 mg
  Sumalate™† (elemental iron) ...............7 mg

*Ester-C® is a patented pharmaceutical grade material consisting of calcium ascorbate and calcium threonate.
Ester-C® is a licensed trademark of The Ester C Company.
†Sumalate™ (ferrous asparto glycinate) is a trademark of Albion International, Inc., Clearfield, Utah. U.S. Patent pending.

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

Indications & Dosage

INDICATIONS

PrimaCare® ONE (prescription prenatal, postnatal multivitamin) is indicated to provide vitamin/mineral and omega-3 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.

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED

PrimaCare® ONE (prescription prenatal, postnatal multivitamin) prenatal/postnatal multivitamin/mineral capsules are purple soft gelatin capsules, imprinted "Ther-Rx 200" in white ink, packaged in bottles of 30 capsules (NDC 64011-200-19). Store at controlled room temperature 15°-30° C (59°-86° F).

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

03/07. Manufactured by Accucaps Industries Limited Windsor, Ontario, Canada. Marketed by Ther-Rx Corporation St. Louis, MO 63044. FDA rev date: n/a

SLIDESHOW

16 Early Signs & Symptoms of Pregnancy: Could You Be Pregnant? See Slideshow
Side Effects & Drug Interactions

SIDE EFFECTS

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

DRUG INTERACTIONS

No information provided.

Warnings & Precautions

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.

WARNING: 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.

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.

Overdosage & Contraindications

OVERDOSE

No information provided.

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Clinical Pharmacology

CLINICAL PHARMACOLOGY

No information provided.

Medication Guide

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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