Escavite D

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

In rare cases, this medicine may discolor your tooth enamel. This has occurred mainly with large doses or long-term use. Stop using multivitamin with iron and fluoride and call your dentist or doctor at once if you notice any change in the appearance of your teeth.

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.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not use this medicine without a doctor's advice.

Take your medicine with a full glass of water.

The chewable tablet must be chewed before you swallow it.

Do not give a chewable tablet to a child younger than 4 years old. The child may choke on the tablet. Use only liquid forms of this medicine in young children.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Brush your teeth regularly, and visit a dentist every 6 months. Taking multivitamin with iron and fluoride is not a replacement for good oral hygiene and routine dental checkups.

Store this medicine in its original container at room temperature away from moisture, heat, and light. Do not allow the liquid to freeze.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of iron can be fatal to a child younger than 6 years old.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

• It is used to help growth and good health.
• Fluoride may be in the vitamin to prevent tooth decay.

• If your child has an allergy to this medicine or any part of Escavite D.
• If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If your drinking water contains enough fluoride for your child. Talk with the doctor if you are not sure.
• If your child has too much iron in the body.

This is not a list of all drugs or health problems that interact with this medicine.

Tell the doctor and pharmacist about all of your child's drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take Escavite D with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

This product contains iron.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdosage, call a doctor or a poison control center immediately.

Tablets should be chewed or crushed before they are swallowed.

This product is not recommended for children under age 4 due to risk of choking.

Escavite® D Multi-vitamin with Iron and Fluoride Chewable Tablets 0.25 mg are dye free, off-white speckled, round shaped, cherry-flavored chewable tablets debossed with E on one side and plain on the other. They are available in bottles of 60 chewable tablets (Product Code 58809-829-60) and 1 count physician samples (Product Code 58809-829-02).

STORAGE

Store at 25°C (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 with a child-resistant closure as defined in the USP/NF.

KEEP OUT OF REACH OF CHILDREN

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.
• Change in look of teeth or gums.
• 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.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child's doctor or get medical help if any of these side effects or any other side effects bother your child 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 child's doctor. Call your child's 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.

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