Prenatal Vitamins Plus Low Iron

Prenatal Vitamins Plus Low Iron
SPL v28
SPL
SPL Set ID ed793721-e869-43de-9d6e-6dc9c8230e36
Route
ORAL
Published
Effective Date 2025-05-07
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Vitamin A (924 ug) .beta.-carotene (276 ug) Ascorbic Acid (120 mg) Cholecalciferol (10 ug) .alpha.-tocopherol, Dl- (10 mg) Riboflavin (1.84 mg) Niacinamide (3 mg) Pyridoxine (20 mg) Folic Acid (1667 ug) Cyanocobalamin (12 ug) Calcium Cation (200 mg) Ferrous Cation (27 mg) Zinc Oxide (25 mg) Cupric Cation (2 mg)
Inactive Ingredients
Hydroxypropyl Methylcellulose Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Peg-400 Stearic Acid Ci 77891 Fd&c Blue No. 2 Curry Red Yellow 6

Identifiers & Packaging

Pill Appearance
Imprint: P;5 Shape: oval Color: brown Size: 9 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2013-04-01 Until 2025-04-30

Description

Supplement Facts Serving Size: 1 Tablet Amount per Serving % Daily Value Daily Value is for Pregnant and Lactating Women Vitamin A 1200 mcg 92% (Acetate and Beta Carotene) RAE Vitamin C (Ascorbic Acid) 120 mg 100% Vitamin D-3 (Cholecalciferol) 10 mcg 67% Vitamin E (dl-α Tocopheryl Acetate) 10 mg 53% Vitamin B-1 (Thiamine Mononitrate) 1.84 mg 131% Vitamin B-2 (Riboflavin) 3 mg 188% Niacin (Niacinamide) 20 mg 111% Vitamin B-6 (Pyridoxine HCl) 10 mg 500% Folic Acid 1667 mcg 278% DFE (1 mg) Vitamin B-12 (Cyanocobalamin) 12 mcg 429% Calcium (Calcium Carbonate) 200 mg 15% Iron (Ferrous Fumarate) 27 mg 100% Zinc (Zinc Oxide) 25 mg 192% Copper(Cupric Oxide) 2 mg 154% Other Ingredients: Hypromellose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Stearic Acid, Titanium Dioxide, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow #6 lake

How Supplied

Product: 50090-0616 NDC: 50090-0616-0 100 TABLET in a BOTTLE, PLASTIC


Medication Information

How Supplied

Product: 50090-0616

NDC: 50090-0616-0 100 TABLET in a BOTTLE, PLASTIC

Description
Supplement Facts
Serving Size: 1 Tablet Amount per Serving % Daily Value
Daily Value is for Pregnant and Lactating Women
Vitamin A 1200 mcg 92%
(Acetate and Beta Carotene) RAE
Vitamin C (Ascorbic Acid) 120 mg 100%
Vitamin D-3 (Cholecalciferol) 10 mcg 67%
Vitamin E (dl-α Tocopheryl Acetate) 10 mg 53%
Vitamin B-1 (Thiamine Mononitrate) 1.84 mg 131%
Vitamin B-2 (Riboflavin) 3 mg 188%
Niacin (Niacinamide) 20 mg 111%
Vitamin B-6 (Pyridoxine HCl) 10 mg 500%
Folic Acid 1667 mcg 278%
DFE (1 mg)
Vitamin B-12 (Cyanocobalamin) 12 mcg 429%
Calcium (Calcium Carbonate) 200 mg 15%
Iron (Ferrous Fumarate) 27 mg 100%
Zinc (Zinc Oxide) 25 mg 192%
Copper(Cupric Oxide) 2 mg 154%

Other Ingredients: Hypromellose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Stearic Acid, Titanium Dioxide, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow #6 lake

Description

Prenatal Plus Vitamins is a prescription folic acid containing dietary vitamin and mineral supplement for women before, during and after pregnancy.

Section 42229-5

Manufactured for Patrin Pharma

Skokie, IL 60076

Call (800) 936 3088

Rev 02.1120

Lot/Exp Date

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

Store at room temperature, USP. Protect from light and moisture. Dispense in a tight, light-resistant container. Contact with moisture may discolor or erode tablets.

Warning

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. Keep this product out of the reach of children. In case of accidental overdose, call a Physician or Poison Control Center immediately.

Directions

Use before, during and after pregnancy under the supervision of a medical professional. One tablet daily or as prescribed.

Prenatal With Ferrous Fum and Folic Acid

Structured Label Content

Description (34089-3)
Supplement Facts
Serving Size: 1 Tablet Amount per Serving % Daily Value
Daily Value is for Pregnant and Lactating Women
Vitamin A 1200 mcg 92%
(Acetate and Beta Carotene) RAE
Vitamin C (Ascorbic Acid) 120 mg 100%
Vitamin D-3 (Cholecalciferol) 10 mcg 67%
Vitamin E (dl-α Tocopheryl Acetate) 10 mg 53%
Vitamin B-1 (Thiamine Mononitrate) 1.84 mg 131%
Vitamin B-2 (Riboflavin) 3 mg 188%
Niacin (Niacinamide) 20 mg 111%
Vitamin B-6 (Pyridoxine HCl) 10 mg 500%
Folic Acid 1667 mcg 278%
DFE (1 mg)
Vitamin B-12 (Cyanocobalamin) 12 mcg 429%
Calcium (Calcium Carbonate) 200 mg 15%
Iron (Ferrous Fumarate) 27 mg 100%
Zinc (Zinc Oxide) 25 mg 192%
Copper(Cupric Oxide) 2 mg 154%

Other Ingredients: Hypromellose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Stearic Acid, Titanium Dioxide, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow #6 lake

Section 42229-5 (42229-5)

Manufactured for Patrin Pharma

Skokie, IL 60076

Call (800) 936 3088

Rev 02.1120

Lot/Exp Date

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

Store at room temperature, USP. Protect from light and moisture. Dispense in a tight, light-resistant container. Contact with moisture may discolor or erode tablets.

Warning (WARNING)

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. Keep this product out of the reach of children. In case of accidental overdose, call a Physician or Poison Control Center immediately.

Directions

Use before, during and after pregnancy under the supervision of a medical professional. One tablet daily or as prescribed.

Description

Prenatal Plus Vitamins is a prescription folic acid containing dietary vitamin and mineral supplement for women before, during and after pregnancy.

How Supplied (HOW SUPPLIED)

Product: 50090-0616

NDC: 50090-0616-0 100 TABLET in a BOTTLE, PLASTIC

Prenatal With Ferrous Fum and Folic Acid (Prenatal with Ferrous Fum and Folic Acid)

Advanced Ingredient Data


Raw Label Data

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