Active FE

• It is used to help with some kinds of anemia.
• It is used to help growth and good health.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to this medicine or any part of Active FE.
• 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 are taking levodopa.
• If you have too much iron in your body.
• If you have certain types of anemia like pernicious anemia or hemolytic anemia.

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 Active FE with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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 your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• 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 Active FE 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 Active FE (vitamin B complex and iron combinations tablets and capsules). 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

OTHER INGREDIENTS: Coating (FD&C Yellow#6 Lake, FD&C Blue#2 Lake, FD&C Red#40 Lake, hydroxypropyl methylcellulose, polyvinyl alcohol, triacetin, talc, titanium dioxide), croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide, silica, and stearic acid.

General

Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with Active FE™. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible.

Folic Acid

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies on this product have not been performed in subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious and start at the lower end of the dosing range.

Adverse reactions with iron therapy may include GI irritations, constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Carbonyl iron based products may decrease the absorption of medicines. Talk to your doctor and pharmacist before taking carbonyl products if you take any prescription or over-the-counter medicines.

Antioxidant Multiple Vitamins (A,D,E,K-intensive) and Minerals oral capsule:
4 to 10 years: 1 capsule orally once daily.
11 years or older: 2 capsules orally once daily.

Antioxidant Multiple Vitamins and Minerals oral liquid and
Antioxidant Multiple Vitamins (A,D,E,K-intensive) and Minerals oral liquid:
1 year or less: 1 mL orally once a day.
1 to 3 years: 2 mL orally once a day.

Multiple Vitamins with Zinc oral capsule:
4 to 10 years: 1 capsule orally once daily.
11 years or older: 2 capsules orally once daily.

Vitamin B Complex with Folic Acid and Minerals oral tablet:
6 years or older: 1 to 2 tablets orally once or twice daily.

Rx Only

Description: Calcium-Folic Acid Plus D Chewable Wafers are a chewable Calcium and Folic Acid Formula with Vitamin D, Magnesium and other nutrients for the maintenance and support of special dietary needs of any individual where supplementation with the ingredients contained within would prove beneficial including: premenopausal, menopausal and postmenopausal patients pertaining to the loss of calcium or calcium deficit, as well as cardiovascular wellness managed through dietary therapy.

Other Ingredients: Fructose, Natural Cocoa Dutch Chocolate, Stearic Acid, Plasdone, Natural Chocolate Flavor, Magnesium Stearate, Acacia Gum, Silicon Dioxide.

Nutrition Information: Each wafer contains 11 calories and 2 grams of carbohydrates.

Indications and Usage: Calcium-Folic Acid Plus D Chewable Wafers are indicated, in addition to diet, to help satisfy the distinctive nutritional requirements of individuals under the supervision of a physician for the treatment of calcium deficiency, skeletal weakness and osteoporosis. Calcium-Folic Acid Plus D Chewable Wafers supplementation may be beneficial to individuals who have an insufficient dietary intake of the nutrients contained therein. Calcium and vitamin D supplementation may be useful in both preventing and treating osteoporosis. Vitamin D supplementation may be beneficial to those who are institutionalized and/or have reduced exposure to sunlight. Folic acid, vitamin B6, and vitamin B12, may help reduce the risk of cardiovascular disease by lowering blood levels of homocysteine. If dietary intake of calcium is inadequate, patients currently taking bisphosphonates for treatment of osteoporosis should be instructed to take calcium and vitamin D daily (Calcium-Folic Acid Plus D Chewable Wafers).

Contraindications: Calcium-Folic Acid Plus D Chewable Wafers are contraindicated in patients with hypersensitivity to any of its components. Calcium and vitamin D supplementation is contraindicated in those with hypercalcemia or conditions that may lead to hypercalcemia and those who form calcium containing stones are generally advised not to take supplemental calcium. Concomitant use of iron and calcium may inhibit the absorption of iron. Concomitant use of quinolones or tetracyclines with calcium may decrease the absorption of these medications. Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. The use of folic acid doses above 1 milligram/day may precipitate or exacerbate the neurological damage of vitamin B12 deficiency. High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol and valproic acid.

Precautions: Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive.

Drug Interactions: As little as 5 mg of pyridoxine (vitamin B6) daily can decrease the efficacy of levodopa. Therefore, Calcium-Folic Acid Plus D Chewable Wafers are not recommended for patients undergoing such therapy.

Information for Patients: Calcium-Folic Acid Plus D Chewable Wafers are medical food for use only under the direction and supervision of a licensed physician. Total intakes of greater than 2,000 mg of calcium provide no added benefit to bone health.

Pregnancy: Shall only be administered under the supervision of a physician.

Pediatric: Not recommended for pediatric use.

Adverse Reactions: Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in Calcium-Folic Acid Plus D Chewable Wafers. However, allergic and/or idiosyncratic reactions to vitamins even at lower potencies or any ingredient are possible.

Warning: Keep this and all medications out of the reach of children.

Dosage and Administration: Chew one wafer twice daily or as prescribed by a physician.

How Supplied: Brown-mottled, round shaped wafer, debossed on scored side with “BP 706”, plain on the other side. Calcium-Folic Acid Plus D Chewable Wafers are supplied in bottles of 60 wafers (42192-706-60). Store at room temperature, 15° - 30°C (59°- 86°F). Protect from light and moisture. The listed product number is not a National Drug Code, but has merely been formatted to comply with industry practice standard for pharmacy and insurance computer systems.

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein.

THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

Manufactured for:
Acella Pharmaceuticals, LLC
Alpharetta, GA 30022
1-800-541-4802

Rev.0313