Cholecalciferol is vitamin D3. Vitamin D helps your body absorb calcium.

Folic acid is vitamin B9, or folate. Vitamin B9 helps your body produce and maintain new cells. Folic acid also helps prevent several types of birth defects when taken by pregnant women.

Ortho DF is a combination medicine used in people who do not get enough of these vitamins in their diets to maintain adequate health.

Ortho DF may also be used for purposes not listed in this medication guide.

You should not take this medicine if you have had an allergic reaction to vitamin D, or if you have high levels of calcium or vitamin D in your body or any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Always follow directions on the medicine label about giving cholecalciferol and vitamin D to a child. Your child's dose will depend on age, weight, diet, and other factors.

Learn about the foods you should eat to make sure you get enough calcium and vitamin D in your diet. Your Ortho DF dose may need to be adjusted as you make changes to your diet. Use only the recommended dose of cholecalciferol and folic acid.

Ortho DF may be only part of a complete program of treatment that also includes dietary changes and taking calcium and vitamin supplements. Follow your doctor's instructions very closely.

Store at room temperature away from moisture, heat, and light.

You should not use Ortho DF if you have ever had an allergic reaction to vitamin D or folic acid, or if you have:

• high levels of vitamin D in your body (hypervitaminosis D);

• high levels of calcium in your blood (hypercalcemia); or

• any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

Folic acid is sometimes used in combination with other medications to treat pernicious anemia. However, Ortho DF will not treat Vitamin B12 deficiency and will not prevent possible damage to the spinal cord. Take all of your medications as directed by your doctor.

Tell your doctor if you have ever had:

• vitamin B12 deficiency (pernicious anemia);

• heart disease;

• kidney disease; or

• a thyroid disorder.

Tell your doctor if you are pregnant or breastfeeding.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of vitamin D can cause serious or life-threatening side effects.

Overdose symptoms may include nausea, loss of appetite, thirst, urinating more or less than usual, body aches, stiffness, confusion, or irregular heartbeats.

Ask a doctor or pharmacist before taking any multivitamins, mineral supplements, or antacids while you are taking Ortho DF.

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

Stop taking Ortho DF and call your doctor at once if you have:

• nausea, vomiting, decreased appetite;

• weakness; or

• increased urination.

Less serious side effects may be more likely, and you may have none at all.

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.

If you take other medications, take them at least 2 hours before or 2 hours after you take Ortho DF. Certain medications can make it harder for your body to absorb vitamin D.

Other drugs may affect Ortho DF, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.