NDC 39328-106 Prenatal Vitamins Plus Low Iron

Prenatal With Ferrous Fum And Folic Acid

NDC Product Code 39328-106

NDC CODE: 39328-106

Proprietary Name: Prenatal Vitamins Plus Low Iron 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: Prenatal With Ferrous Fum And 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.

  • Drug uses not available
  • Niacin (nicotinic acid) is used to prevent and treat niacin deficiency (pellagra). Niacin deficiency may result from certain medical conditions (such as alcohol abuse, malabsorption syndrome, Hartnup disease), poor diet, or long-term use of certain medications (such as isoniazid). Niacin deficiency can cause diarrhea, confusion (dementia), tongue redness/swelling, and peeling red skin. Niacin is also known as vitamin B3, one of the B-complex vitamins. Vitamins help to support the body's ability to make and break down natural compounds (metabolism) needed for good health. Niacinamide (nicotinamide) is a different form of vitamin B3 and does not work the same as niacin. Do not substitute unless directed by your doctor. 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.
  • 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.
  • Drug uses not available
  • Drug uses not available

Product Characteristics

Color(s):
BROWN (C48332 - BEIGE)
Shape: OVAL (C48345)
Size(s):
9 MM
Imprint(s):
P;5
Score: 1

NDC Code Structure

NDC 39328-106-10

Package Description: 100 TABLET in 1 BOTTLE, PLASTIC

NDC 39328-106-50

Package Description: 500 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Prenatal Vitamins Plus Low Iron with NDC 39328-106 is a a human prescription drug product labeled by Patrin Pharma, Inc.. The generic name of Prenatal Vitamins Plus Low Iron is prenatal with ferrous fum and folic acid. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Patrin Pharma, Inc.

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.

Prenatal Vitamins Plus Low Iron 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.

  • VITAMIN A ACETATE 3080 [iU]/1
  • BETA CAROTENE 920 [iU]/1
  • ASCORBIC ACID 120 mg/1
  • CHOLECALCIFEROL 400 [iU]/1
  • .ALPHA.-TOCOPHEROL ACETATE, DL- 22 mg/1
  • THIAMINE 1.84 mg/1
  • RIBOFLAVIN 3 mg/1
  • NIACIN 20 mg/1
  • PYRIDOXINE HYDROCHLORIDE 10 mg/1
  • FOLIC ACID 1 mg/1
  • CYANOCOBALAMIN 12 ug/1
  • CALCIUM CARBONATE 200 mg/1
  • IRON 27 mg/1
  • ZINC 25 mg/1
  • COPPER 2 mg/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.

  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
  • ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • DEXTROSE (UNII: IY9XDZ35W2)
  • ACACIA (UNII: 5C5403N26O)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • METHYLCELLULOSE (100 MPA.S) (UNII: 4GFU244C4J)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SORBIC ACID (UNII: X045WJ989B)
  • SOY PROTEIN (UNII: R44IWB3RN5)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SUCROSE (UNII: C151H8M554)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRICALCIUM PHOSPHATE (UNII: K4C08XP666)

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.
  • 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.

  • 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)
  • Nicotinic Acid - [EPC] (Established Pharmacologic Class)
  • Nicotinic Acids - [CS]
  • 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 - [CS]
  • Copper-containing Intrauterine Device - [EPC] (Established Pharmacologic Class)
  • Decreased Embryonic Implantation - [PE] (Physiologic Effect)
  • Decreased Sperm Motility - [PE] (Physiologic Effect)
  • Inhibit Ovum Fertilization - [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: Patrin Pharma, Inc.
Labeler Code: 39328
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: 04-01-2013 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: 12-31-2020 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.

Prenatal Vitamins Plus Low Iron Product Label Images

Prenatal Vitamins Plus Low Iron 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

Boxed Warning

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a physician or Poison Control Center immediately.

Description

Each Tablet Contains:AmountPer Tablet% DailyValueVitamin A (from Acetate and Beta Carotene)4000 IU80%Vitamin C (Ascorbic Acid)120 mg200%Vitamin D-3 (Cholecalciferol)400 IU100%Vitamin E (dl-Alpha Tocopheryl Acetate)22 mg73%Vitamin B-1(Thiamine Mononitrate)1.84 mg123%Vitamin B-2 (Riboflavin)3 mg176%Niacin (as Niacinamide)20 mg100%Vitamin B-6 (Pyridoxine HCI)10 mg500%Folic Acid1 mg200%Vitamin B-12 (Cyanocobalamin)12 mcg200%Calcium (from Calcium Carbonate)200 mg20%Iron (Ferrous Fumarate)27 mg150%Zinc (Zinc Oxide)25mg167%Copper (Cupric Oxide)2 mg100%Other Ingredients: Ascorbyl Palmitate, Citric Acid anhydrous, DL- alpha Tocopherol, Ethylcellulose, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow #6 lake, Glucose, Gum Acacia, Hypromellose, Magnesium Stearate, Maize Starch, Maltodextrin, Methylcellulose, Microcrystalline Cellulose, Mineral Oil, Mono and di-glycerides, Polyethylene Glycol, Pregelatinzed Corn Starch, Silicon Dioxide, Sorbic Acid, Soy Protein, Stearic Acid, Sucrose, Titanium Dioxide, Tricalcium Phosphate.

Indications & Usage

Indications: To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and nonlactating mother. It is also useful for improving nutritional status prior to conception.

Dosage & Administration

Directions: Before, during and after pregnancy, one tablet daily or as directed by a physician.

Contraindications

Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Precautions

Caution: Folic Acid may partially correct the hematological damage due to Vitamin B-12 deficiency of pernicious anemia while the associated neurological damage progresses.

Storage And Handling

Store at room temperature, USP. Dispense in a well closed light resistant container.

How Supplied

Manufactured in USA for: Patrin Pharma, Inc.Skokie, IL 60076 800-936-3088Rev 01.0313

* Please review the disclaimer below.