Poly-Vita Drops with Iron

• It is used to help growth and good health.

Give Poly-Vita Drops with Iron as ordered by your child's doctor. Read all information given to you. Follow all instructions closely.

• Give this medicine with or without food. Give with food if it causes an upset stomach.
• Some drugs may need to be given with food or on an empty stomach. For some drugs, it does not matter. Check with your pharmacist about how to give Poly-Vita Drops with Iron to your child.
• Follow how to use as you have been told by the doctor or read the package insert.
• Measure liquid doses carefully. Use the measuring device that comes with this medicine.
• Shake well before use.
• Some products may be mixed with formula, fruit juice, or other food or liquids. Some products may need to be put right in your child's mouth. Be sure you know how to give Poly-Vita Drops with Iron (pediatric multivitamin drops with iron) to your child.

What do I do if I miss a dose?

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

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 child's doctor or get medical help right away if your child has 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.
• Black, tarry, or bloody stools.
• Fever.
• Very upset stomach or throwing up.
• Very bad belly pain.
• Throwing up blood or throw up that looks like coffee grounds.
• Stomach cramps.

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.

• If your child's symptoms or health problems do not get better or if they become worse, call your child's doctor.
• Do not share your child's drug with others and do not give anyone else's drug to your child.
• Keep a list of all your child's drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child's doctor.
• Talk with your child's doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. If you have any questions about Poly-Vita Drops with Iron, please talk with your child's doctor, nurse, pharmacist, or other health care provider.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• 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.

This information should not be used to decide whether or not to take Poly-Vita Drops with Iron or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Poly-Vita Drops with Iron. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

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 Poly-Vita Drops with Iron may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.