Ferrous fumarate and iron polysaccharide

You should not use ferrous fumarate and iron polysaccharide if you are allergic to it, or if you have

• iron overload disorder (hemochromatosis, hemosiderosis); or

• hemolytic anemia (caused by the breakdown of red blood cells).

To make sure ferrous fumarate and iron polysaccharide is safe for you, tell your doctor if you have:

• ulcerative colitis;

• stomach ulcers or similar stomach problems; or

• a history of a gastrectomy.

Tell your doctor if you are pregnant, or if you become pregnant during treatment. Your dose needs may be different during pregnancy.

Tell your doctor if you are breast-feeding a baby. Your dose needs may be different while you are nursing.

Do not give this medicine to a child younger than 12 years old.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of iron can be fatal, especially in a young child who has accidentally swallowed it.

Overdose symptoms may include metallic taste in the mouth, bloody or tarry stools, vomiting blood, severe shortness of breath, chest pain, pale skin, blue lips or fingernails, loss of consciousness, or seizure (convulsions).

Applies to ferrous fumarate / iron polysaccharide: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking ferrous fumarate / iron polysaccharide: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include:

• nausea, heartburn, loss of appetite;

• diarrhea, constipation; or

• black or dark colored stools.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

1 capsule orally once a day between meals

Do not administer to pediatric patients under 12-years-old.

Do not exceed manufacturer recommended dosage.