NDC 59088-178 Pretrate

Ferrous Fumarate, Folic Acid

NDC Product Code 59088-178

NDC CODE: 59088-178

Proprietary Name: Pretrate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Ferrous Fumarate, Folic Acid What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is a mineral supplement used to prevent and treat low amounts of magnesium in the blood. Some brands are also used to treat symptoms of too much stomach acid such as stomach upset, heartburn, and acid indigestion. Magnesium is very important for the normal functioning of cells, nerves, muscles, bones, and the heart. Usually, a well-balanced diet provides normal blood levels of magnesium. However, certain situations cause your body to lose magnesium faster than you can replace it from your diet. These situations include treatment with water pills (diuretics such as furosemide, hydrochlorothiazide), a poor diet, alcoholism, or other medical conditions (e.g., severe diarrhea/vomiting, stomach/intestinal absorption problems, poorly controlled diabetes).
  • Drug uses not available
  • Drug uses not available
  • Niacinamide (nicotinamide) is a form of vitamin B3 (niacin) and is used to prevent and treat niacin deficiency (pellagra). Niacin deficiency can cause diarrhea, confusion (dementia), tongue redness/swelling, and peeling red skin. Niacinamide is often used instead of niacin because it causes fewer side effects (e.g., flushing). Unlike niacin, niacinamide does not help correct blood fat levels and cannot be substituted for niacin if you are being treated for a blood fat problem (e.g., high cholesterol). Niacin deficiency may happen as a result of poor diet, certain medical conditions (e.g., alcohol abuse, malabsorption syndrome, Hartnup disease), or long-term use of certain medications (e.g., isoniazid). It is best to get your vitamins from healthy foods. A multivitamin may be recommended by your doctor instead of niacinamide because poor diet usually causes deficiencies in more than one vitamin. Vitamins help to support the body's ability to make and break down natural substances (metabolism) and are needed for good health.
  • Folic acid is the man-made form of folate. Folate is a B-vitamin naturally found in some foods. It is needed to form healthy cells, especially red blood cells. Folic acid supplements may come in different forms (such as L-methylfolate, levomefolate, methyltetrahydrofolate). They are used to treat or prevent low folate levels. Low folate levels can lead to certain types of anemia. Conditions that can cause low folate levels include poor diet, pregnancy, alcoholism, liver disease, certain stomach/intestinal problems, kidney dialysis, among others. Women of childbearing age should receive adequate amounts of folic acid either through their diet or supplements to prevent infant spinal cord birth defects.
  • Cyanocobalamin is a man-made form of vitamin B12 used to treat low levels (deficiency) of this vitamin. Vitamin B12 helps your body use fat and carbohydrates for energy and make new protein. It is also important for normal blood, cells, and nerves. Most people get enough vitamin B12 in their diet, but a deficiency may occur in certain health conditions (e.g., poor nutrition, stomach/intestinal problems, infection, cancer). Serious vitamin B12 deficiency may result in anemia, stomach problems, and nerve damage.
  • This medication is used to treat symptoms caused by too much stomach acid such as heartburn, upset stomach, or indigestion. It is an antacid that works by lowering the amount of acid in the stomach. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.
  • This medication is an iron supplement used to treat or prevent low blood levels of iron (e.g., for anemia or during pregnancy). Iron is an important mineral that the body needs to produce red blood cells and keep you in good health.
  • This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.
  • Drug uses not available
  • Potassium iodide is used to loosen and break up mucus in the airways. This helps you cough up the mucus so you can breathe more easily if you have long-term lung problems (e.g., asthma, chronic bronchitis, emphysema). This medication is known as an expectorant. Potassium iodide is also used along with antithyroid medicines to prepare the thyroid gland for surgical removal, to treat certain overactive thyroid conditions (hyperthyroidism), and to protect the thyroid in a radiation exposure emergency. It works by shrinking the size of the thyroid gland and decreasing the amount of thyroid hormones produced. In a radiation emergency, potassium iodide blocks only the thyroid from absorbing radioactive iodine, protecting it from damage and reducing the risk of thyroid cancer. Use this medication along with other emergency measures that will be recommended to you by public health and safety officials (e.g., finding safe shelter, evacuation, controlling food supply).

Product Characteristics

Color(s):
BROWN (C48332 - BEIGE SPECKLED CAPLETS)
Shape: CAPSULE (C48336)
Size(s):
19 MM
Score: 1

NDC Code Structure

  • 59088 - Puretek Corporation

NDC 59088-178-54

Package Description: 30 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Pretrate with NDC 59088-178 is a a human prescription drug product labeled by Puretek Corporation. The generic name of Pretrate is ferrous fumarate, folic acid. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Puretek Corporation

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Pretrate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MAGNESIUM OXIDE 200 mg/1
  • MANGANESE SULFATE 2.6 mg/1
  • VITAMIN A ACETATE 1500 ug/1
  • ASCORBIC ACID 120 mg/1
  • CHOLECALCIFEROL 20 ug/1
  • .ALPHA.-TOCOPHEROL ACETATE, DL- 30 mg/1
  • THIAMINE MONONITRATE 3 mg/1
  • RIBOFLAVIN 3.4 mg/1
  • NIACINAMIDE 20 mg/1
  • PYRIDOXINE HYDROCHLORIDE 50 mg/1
  • FOLIC ACID 1000 ug/1
  • CYANOCOBALAMIN 10 ug/1
  • CALCIUM CARBONATE 200 mg/1
  • FERROUS FUMARATE 27 mg/1
  • ZINC OXIDE 25 mg/1
  • MOLYBDENUM 50 ug/1
  • CHOLINE BITARTRATE 55 mg/1
  • SELENIUM 70 ug/1
  • CHROMIUM NICOTINATE 45 ug/1
  • POTASSIUM IODIDE 150 ug/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CROSPOVIDONE (UNII: 2S7830E561)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Magnetic Resonance Contrast Activity - [MoA] (Mechanism of Action)
  • Paramagnetic Contrast Agent - [EPC] (Established Pharmacologic Class)
  • Vitamin A - [CS]
  • Vitamin A - [EPC] (Established Pharmacologic Class)
  • Vitamin C - [EPC] (Established Pharmacologic Class)
  • Ascorbic Acid - [CS]
  • Vitamin D - [CS]
  • Vitamin D - [EPC] (Established Pharmacologic Class)
  • Vitamin B6 Analog - [EPC] (Established Pharmacologic Class)
  • Vitamin B 6 - [Chemical/Ingredient]
  • Analogs/Derivatives - [Chemical/Ingredient]
  • Vitamin B 12 - [CS]
  • Vitamin B12 - [EPC] (Established Pharmacologic Class)
  • Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
  • Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Calcium - [CS]
  • Cations -
  • Divalent - [CS]
  • Copper Absorption Inhibitor - [EPC] (Established Pharmacologic Class)
  • Decreased Copper Ion Absorption - [PE] (Physiologic Effect)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Puretek Corporation
Labeler Code: 59088
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Pretrate Product Label Images

Pretrate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description:

Each caplet contains:Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU)

Vitamin C (as ascorbic acid)……………………………… 120 mg

Vitamin D3 (as cholecalciferol)………………….. 20 mcg (800 IU)

Vitamin E (dl-alpha tocopheryl acetate)…………… 30 mg (30 IU)

Thiamin (as thiamine mononitrate)………………………… 3 mg

Riboflavin (vitamin B2)……………………………………. 3.4 mg

Niacin (as niacinamide)…………………………………… 20 mg

Vitamin B6 (as pyridoxine hydrochloride)…………………. 50 mg

Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid)

Vitamin B12 (as cyanocobalamin)………………………… 10 mcg

Choline (as choline bitartrate)…………………………….. 55 mg

Calcium (as calcium carbonate)…………………………. 200 mg

Iron (as ferrous fumarate)………………………………… 27 mg

Iodine (as potassium iodine)…………………………….150 mcg

Magnesium (as magnesium oxide)……………………… 200 mg

Zinc (as zinc oxide)……………………………………….. 25 mg

Selenium (as selenium amino acid chelate)………………. 70 mcg

Manganese (as manganese sulfate)……………………… 2.6 mg

Chromium (as chromium polynicotinate)……………….. 45 mcg

Molybdenum (as molybdenum amino acid chelate)……… 50 mcg
Other Ingredients:

Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide,

stearic acid, Clear coating: (hydroxypropyl methylcellulose, PEG-8).

Indications

Pretrate is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years.

Pretrate may be beneficial in improving the nutritional status of women prior to conception.

Contraindications:

This product is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

Warning

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B
12 is deficient.

Precautions

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.
There is a potential danger in administering folic acid to patients with undiagnosed anemia, since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B
12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia.

The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.
For use on the order of a healthcare practitioner.Call your doctor about side effects. To report side effects, call
PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions:

Pretrate is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin orClopidogrel).

Adverse Reactions:

Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.
Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Pretrate after meals may control occasional gastrointestinal disturbances. Pretrate is best absorbed when taken at bedtime.

Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

Overdose:

Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness, and coma. The estimated overdose of orally ingested iron is 300 mg/kg body weight. When overdoses are ingested by children, severe

reactions, including fatalities, have resulted. Pretrate should be stored beyond the reach of children to prevent against accidental iron poisoning.
Keep this and all other drugs out of reach of children.

Treatment:

For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

Dosage And Administration:

Adults (persons over 12 years of age) One (1) Pretrate caplet daily, between meals, or as directed by a physician. Do not administer to children under the age of 12.

How Supplied

Pretrate are beige speckled, oblong, coated caplets in bottles containing 30 caplets – NDC 59088-178-54. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.
Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP]. Protect from light and moisture and avoid excessive heat.

Storage

Do not use if bottle seal is broken.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP].

Protect from light and moisture and avoid excessive heat.

To report a serious adverse event or to obtain product information, contact
877-921-7873.

Pretrate

Manufactured by:

PureTek Corporation

Panorama City, CA 91402

For questions or information

call toll-free:
877-921-7873

* Please review the disclaimer below.