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PrimaCare One

Generic Name: prenatal multivitamins and minerals with iron, folic acid, docusate sodium, and omega-3 fatty acids (pree-NATE-al VYE-ta-mins/MIN-er-als/EYE-urn/FOE-lik AS-id/DOK-ue-sate SOE-dee-um/oh-MAY-ga 3 FA-tee AS-ids)
Brand Name: PrimaCare One

Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children. In case of accidental ingestion, call the poison control center or doctor right away.

PrimaCare One is used for:

Treating or preventing a lack of vitamins or minerals before, during, and after pregnancy and while breast-feeding. It may also be used for treating and preventing certain conditions as determined by your doctor.

PrimaCare One is a vitamin, mineral, iron, folic acid, essential fatty acids, and stool softener combination. It provides vitamins, minerals, iron, folic acid, and essential fatty acids to the body to help meet nutritional requirements. The stool softener helps prevent constipation that sometimes may occur with iron products.

Do NOT use PrimaCare One if:

  • you are allergic to any ingredient in PrimaCare One, including fish or fish oil
  • you have hemochromatosis (a disorder of iron metabolism)

Contact your doctor or health care provider right away if any of these apply to you.

Before using PrimaCare One:

Some medical conditions may interact with PrimaCare One. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances (including soy or fish)
  • if you have stomach or intestinal problems (eg, colitis, Crohn disease, diverticulitis), blood problems (eg, anemia, porphyria cutanea tarda, thalassemia), bleeding problems (eg, hemophilia), or peptic ulcer
  • if you have had multiple blood transfusions
  • if you are on a low-sodium diet

Some MEDICINES MAY INTERACT with PrimaCare One. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Cation exchange resins (eg, sodium polystyrene sulfonate) because side effects, including increased risk of muscle twitches and tremors, nausea, vomiting, numbness in face or extremities, and confusion possibly leading to coma, may be increased by PrimaCare One
  • Oral anticoagulants (eg, warfarin) because the risk of bleeding may be increased by PrimaCare One
  • Fluorouracil because its actions and the risk of its side effects may be increased by PrimaCare One
  • Hydantoins (eg, phenytoin), levodopa, mycophenolate, or penicillamine because their effectiveness may be decreased by PrimaCare One

This may not be a complete list of all interactions that may occur. Ask your health care provider if PrimaCare One may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use PrimaCare One:

Use PrimaCare One as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Check with your doctor or pharmacist to see if you should take PrimaCare One with food or on an empty stomach. If stomach upset occurs, take with food to reduce stomach irritation.
  • Take PrimaCare One by mouth with a full glass of water (8 oz/240 mL).
  • Avoid taking antacids within several hours before or after PrimaCare One.
  • Avoid taking PrimaCare One with dairy products; they may interfere with the absorption of the iron in PrimaCare One.
  • Many medicines (eg, used for infection, blood pressure, immune system suppression, osteoporosis, thyroid problems) should not be taken at the same time as PrimaCare One; their effectiveness may be decreased. Ask your doctor or pharmacist if your dose of PrimaCare One should be separated from your dose of any of your other medicines.
  • If you miss a dose of PrimaCare One, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use PrimaCare One.

Important safety information:

  • PrimaCare One may darken the stools. This is normal and not a cause for concern
  • PrimaCare One has iron in it. Iron overdose is a leading cause of fatal poisoning in CHILDREN younger than 6 years of age. In case of an overdose, call a doctor or poison control center right away.
  • PREGNANCY and BREAST-FEEDING: PrimaCare One is intended for use during pregnancy. If you are or will be breast-feeding while you use PrimaCare One, check with your doctor.

Possible side effects of PrimaCare One:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dark or discolored stools; diarrhea; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or streaks of blood in the stools; stomach pain or cramping.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry stools; chest pain; lack of feeling alert; loss of balance; seizure; severe nausea, vomiting, diarrhea, or stomach pain; shortness of breath; sluggishness; trouble breathing; unusual tiredness or weakness; unusually pale skin; weak pulse.

Proper storage of PrimaCare One:

Store PrimaCare One at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep PrimaCare One out of the reach of children and away from pets.

General information:

  • If you have any questions about PrimaCare One, please talk with your doctor, pharmacist, or other health care provider.
  • PrimaCare One is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take PrimaCare One or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about PrimaCare One. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to PrimaCare One. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using PrimaCare One.

Issue Date: June 3, 2015