Fer-In-Sol

In the U.S.

• Auryxia
• Beef,Iron & Wine
• Bifera
• Elite Iron
• Femiron
• Feosol
• Fergon
• Ferrex 150
• Hemocyte

In Canada

• Fer-In-Sol
• Palafer
• Pms-Ferrous Sulfate

Available Dosage Forms:

• Tablet, Chewable
• Tablet
• Liquid
• Capsule
• Solution
• Tablet, Enteric Coated
• Powder
• Tablet, Extended Release
• Suspension
• Capsule, Liquid Filled
• Syrup
• Capsule, Extended Release
• Elixir

Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, it cannot produce the number of normal red blood cells needed to keep you in good health. This condition is called iron deficiency (iron shortage) or iron deficiency anemia.

Although many people in the U.S. get enough iron from their diet, some must take additional amounts to meet their needs. For example, iron is sometimes lost with slow or small amounts of bleeding in the body that you would not be aware of and which can only be detected by your doctor. Your doctor can determine if you have an iron deficiency, what is causing the deficiency, and if an iron supplement is necessary.

Lack of iron may lead to unusual tiredness, shortness of breath, a decrease in physical performance, and learning problems in children and adults, and may increase your chance of getting an infection.

Some conditions may increase your need for iron. These include:

• Bleeding problems
• Burns
• Hemodialysis
• Intestinal diseases
• Stomach problems
• Stomach removal
• Use of medicines to increase your red blood cell count

In addition, infants, especially those receiving breast milk or low-iron formulas, may need additional iron.

Increased need for iron supplements should be determined by your health care professional.

Injectable iron is administered only by or under the supervision of your health care professional. Other forms of iron are available without a prescription; however, your health care professional may have special instructions on the proper use and dose for your condition.

This section provides information on the proper use of a number of products that contain iron supplement. It may not be specific to Fer-In-Sol. Please read with care.

After you start using this dietary supplement, continue to return to your health care professional to see if you are benefiting from the iron. Some blood tests may be necessary for this.

Iron is best absorbed when taken on an empty stomach, with water or fruit juice (adults: full glass or 8 ounces; children: ½ glass or 4 ounces), about 1 hour before or 2 hours after meals. However, to lessen the possibility of stomach upset, iron may be taken with food or immediately after meals.

For safe and effective use of iron supplements:

• Follow your health care professional's instructions if this dietary supplement was prescribed.
• Follow the manufacturer's package directions if you are treating yourself. If you think you still need iron after taking it for 1 or 2 months, check with your health care professional.

Liquid forms of iron supplement tend to stain the teeth. To prevent, reduce, or remove these stains:

• Mix each dose in water, fruit juice, or tomato juice. You may use a drinking tube or straw to help keep the iron supplement from getting on the teeth.
• When doses of liquid iron supplement are to be given by dropper, the dose may be placed well back on the tongue and followed with water or juice.
• Iron stains on teeth can usually be removed by brushing with baking soda (sodium bicarbonate) or medicinal peroxide (hydrogen peroxide 3%).

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules, tablets, oral solution):
  • To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
    For the U.S.
    • Adult and teenage males—10 milligrams (mg) per day.
    • Adult and teenage females—10 to 15 mg per day.
    • Pregnant females—30 mg per day.
    • Breast-feeding females—15 mg per day.
    • Children 7 to 10 years of age—10 mg per day.
    • Children 4 to 6 years of age—10 mg per day.
    • Children birth to 3 years of age—6 to 10 mg per day.
    For Canada
    • Adult and teenage males—8 to 10 mg per day.
    • Adult and teenage females—8 to 13 mg per day.
    • Pregnant females—17 to 22 mg per day.
    • Breast-feeding females—8 to 13 mg per day.
    • Children 7 to 10 years of age—8 to 10 mg per day.
    • Children 4 to 6 years of age—8 mg per day.
    • Children birth to 3 years of age—0.3 to 6 mg per day.
  • To treat deficiency:
    • Adults, teenagers, and children— The dose will be determined by your doctor, based on your condition.
• For injection dosage forms:
  • Adults, teenagers, and children— The dose will be determined by your doctor, based on your condition.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Backache , groin, side, or muscle pain
• chest pain
• chills
• dizziness
• fainting
• fast heartbeat
• fever with increased sweating
• flushing
• headache
• metallic taste
• nausea or vomiting
• numbness, pain, or tingling of hands or feet
• pain or redness at injection site
• redness of skin
• skin rash or hives
• swelling of mouth or throat
• troubled breathing

• Abdominal or stomach pain
• cramping (continuing) or soreness

• Double vision
• general unwell feeling
• weakness without feeling dizzy or faint

• Chest or throat pain, especially when swallowing
• stools with signs of blood (red or black color)

Symptoms of iron overdose may not occur for up to 60 minutes or more after the overdose was taken. By this time you should have had emergency room treatment. Do not delay going to emergency room while waiting for signs to appear.

• Diarrhea (may contain blood)
• fever
• nausea
• stomach pain or cramping (sharp)
• vomiting, severe (may contain blood)

• Bluish-colored lips, fingernails, and palms of hands
• convulsions (seizures)
• pale, clammy skin
• shallow and rapid breathing
• unusual tiredness or weakness
• weak and fast heartbeat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Constipation
• diarrhea
• leg cramps
• nausea
• vomiting

Stools commonly become dark green or black when iron preparations are taken by mouth. This is caused by unabsorbed iron and is harmless. However, in rare cases, black stools of a sticky consistency may occur along with other side effects such as red streaks in the stool, cramping, soreness, or sharp pains in the stomach or abdominal area. Check with your health care professional immediately if these side effects appear.

If you have been receiving injections of iron, you may notice a brown discoloration of your skin. This color usually fades within several weeks or months.

• Darkened urine
• heartburn
• stained teeth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• If you have an allergy to ferrous sulfate or any other part of Fer-In-Sol (ferrous sulfate drops).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Anemia from a cause other than low iron stores or too much iron in your body.

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

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Fer-In-Sol with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use Fer-In-Sol as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• This medicine works better if you take it on an empty stomach. You may take this medicine with food if it causes an upset stomach. Some foods like eggs, whole grain breads, cereal, dairy products, coffee, and tea may make Fer-In-Sol not work as well. If this medicine causes an upset stomach, talk with your doctor about the best way to take Fer-In-Sol with food.
• If antacids are used, they may need to be taken at some other time than this medicine. Talk with your doctor or pharmacist.
• Only use the measuring device that comes with this liquid drug.
• Shake well before use.
• You may put Fer-In-Sol (ferrous sulfate drops) right in the mouth or you may mix it with formula, fruit juice, cereal or other food, water or juice. Take the whole dose.

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.

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:

• Belly pain.
• Loose stools (diarrhea).
• Hard stools (constipation).
• Change in color of stool to green.
• Not hungry.
• Upset stomach or throwing up.
• Stomach cramps.
• Staining of the mouth, teeth, or fillings.

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.

Applies to ferrous sulfate: oral tablet, oral tablet delayed release, oral tablet extended release

Other dosage forms:

• oral tablet
• oral elixir, oral liquid, oral solution, oral syrup

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:

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

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.

Applies to ferrous sulfate: compounding powder, oral capsule extended release, oral delayed release tablet, oral elixir, oral liquid, oral syrup, oral tablet, oral tablet extended release

Gastrointestinal

Frequency not reported: Nausea, epigastric pain, altered bowel habit (constipation, diarrhea), discolored (blackened) stools, fecal impaction, gastrointestinal irritation, contact irritation resulting in erosion or ulceration, tooth discoloration[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions (from rashes to anaphylaxis)[Ref]

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