Active FE

Name: Active FE

What Is Active Fe?

This medicine is a combination of many different vitamins and minerals that are normally found in foods and other natural sources.

Multivitamins and minerals are used to provide substances that are not taken in through the diet. Multivitamins and minerals are also used to treat vitamin or mineral deficiencies caused by illness, pregnancy, poor nutrition, digestive disorders, certain medications, and many other conditions.

Multivitamins and minerals may also be used for purposes not listed in this medication guide.

Never take more than the recommended dose of multivitamins and minerals.

An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects if taken in large doses. Certain minerals may also cause serious overdose symptoms if you take too much.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium.

Multivitamins and minerals can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medicine than directed on the label or prescribed by your doctor.

Ask a doctor or pharmacist if it is safe for you to use multivitamins and minerals if you have other medical conditions or allergies.

Your dose needs may be different during pregnancy. Do not take this medicine without telling your doctor if you are pregnant or plan to become pregnant. Some vitamins and minerals can harm an unborn baby if taken in large doses. You may need to use a prenatal vitamin specially formulated for pregnant women.

It is not known whether multivitamins and minerals passes into breast milk or if it could harm a nursing baby. Your dose needs may be different while you are nursing. Tell your doctor if you are breast-feeding a baby.

Active Fe Side Effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling.

When taken as directed, multivitamins and minerals are not expected to cause serious side effects. Common side effects may include:

  • upset stomach;
  • headache; or
  • unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Active Fe Interactions

Avoid taking more than one vitamin/mineral product at the same time unless your doctor tells you to. Taking similar vitamin products together can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin and mineral contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Do not take this medicine with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain minerals.

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Ask a doctor or pharmacist if it is safe for you to use multivitamins and minerals if you are also using any of the following drugs:

  • tretinoin or isotretinoin;
  • an antacid;
  • an antibiotic;
  • a diuretic or "water pill";
  • heart or blood pressure medications;
  • a sulfa drug; or
  • NSAIDs (nonsteroidal anti-inflammatory drugs)--ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with multivitamins and minerals, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

How is this medicine (Active FE) best taken?

  • Use Active FE as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • Some drugs may need to be taken with food or on an empty stomach. For some drugs it does not matter. Check with your pharmacist about how to take this medicine.
  • This medicine may prevent other drugs taken by mouth from getting into the body. If you take other drugs by mouth, you may need to take them at some other time than Active FE. Talk with your doctor.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

How is Active FE Supplied

Active FE™ is supplied as red capsule shaped tablets with imprint FE1 in child-resistant bottles containing 30 tablets. (58809-725-30)

STORAGE

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container.

KEEP OUT OF REACH OF CHILDREN.

Rx
MADE IN CANADA

MANUFACTURED FOR: GM Pharmaceuticals, Inc.
Arlington, TX 76015

Rev. 05/2014
Covered by U.S. Patent# 7998500

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Hard stools (constipation).
  • Change in color of stool to green.
  • Loose stools (diarrhea).
  • Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to multivitamin with iron: injectable solution, oral capsule, oral capsule extended release, oral liquid, oral powder for reconstitution, oral tablet, oral tablet chewable, oral tablet extended release

Gastrointestinal

Gastrointestinal side effects associated with oral iron therapy have included nausea, constipation, anorexia, heartburn, vomiting, and diarrhea. These effects are generally dose-related. In addition, stools may appear darker in color in patients taking products containing iron. Iron oral preparations may rarely cause Hemoccult-positive stools, patients with positive tests generally require further work-up.[Ref]

Other

Stained teeth have primarily occurred following ingestion of iron liquid preparation.

Iron overload (i.e., hemosiderosis) has been reported in patients genetically predisposed, or have underlying disorders, that augment the absorption of iron. It has also occurred following administration of excessive parenteral iron therapy, combination of oral and parenteral iron, or in patients with hemoglobinopathies that were erroneously diagnosed as iron deficiency anemia. Hemosiderosis is treated with repeated phlebotomy or long-term administration of deferoxamine. The liver is particularly susceptible to toxicity in iron-overload states.[Ref]

Other side effects associated with oral iron products have included stained teeth and iron overload (hemosiderosis). Secondary hemochromatosis due to prolonged iron ingestion has been reported rarely.[Ref]

Metabolic

Metabolic side effects associated with iron have included decreased absorption of thyroxine (T4).[Ref]

Some side effects of Active Fe may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very upset stomach or throwing up.
  • Very loose stools (diarrhea).
  • Very hard stools (constipation).
  • Muscle weakness.
  • Numbness and tingling.

Dialysis

Date not available

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