Suplevit

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.
• Swelling.
• A burning, numbness, or tingling feeling that is not normal.
• Headache.
• Dizziness.
• Feeling tired or weak.
• Sweating a lot.
• Joint pain or swelling.
• Shortness of breath.
• Feeling full.
• Bloating.
• Very upset stomach or throwing up.
• Black, tarry, or bloody stools.
• Fever.
• Very bad belly pain.
• Throwing up blood or throw up that looks like coffee grounds.
• Stomach cramps.

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:

• Loose stools (diarrhea).
• Upset stomach or throwing up.
• Belly pain.
• Not hungry.
• Hard stools (constipation).
• Change in color of stool to green.

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.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Protect from heat.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Applies to multivitamin with iron: oral capsule, oral miscellaneous, oral solution reconstituted, oral tablet, oral tablet extended release

Other dosage forms:

• oral powder, oral tablet chewable
• oral capsule, oral elixir, oral liquid, oral miscellaneous, oral solution, oral tablet
• oral liquid, oral solution, oral suspension

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