Prenatal Vitamins Plus Low Iron

SPL v2

SPL

SPL Set ID 1b8ef3ea-5563-48ef-ba5e-27e0b454efb9

Route

ORAL

Published

Effective Date 2025-01-20

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

Hypromellose, Unspecified Magnesium Stearate Maltodextrin Microcrystalline Cellulose Polyethylene Glycol 400 Stearic Acid Titanium Dioxide Fd&c Blue No. 2 Fd&c Red No. 40 Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance

Imprint: P;5 Shape: oval Color: brown Size: 9 mm Score: 1

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2025-01-20

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

Medication Information

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

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Section 51945-4

DRUG: Prenatal Plus Vitamins

GENERIC: prenatal with ferrous fumarate and folic acid

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-4258-0

COLOR: brown

SHAPE: OVAL

SCORE: No score

SIZE: 9 mm

IMPRINT: P;5

PACKAGING: 100 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

Vitamin A Acetate 924ug in 1
Beta Carotene 276ug in 1
Ascorbic Acid 120mg in 1
Cholecalciferol 10ug in 1
.Alpha.-TocopheroL Acetate, DL- 10mg in 1
Thiamine Mononitrate 1.84mg in 1
Riboflavin 3mg in 1
Niacinamide 20mg in 1
Pyridoxine Hydrochloride 10mg in 1
Folic Acid 1667ug in 1
Cyanocobalamin 12ug in 1
Calcium Carbonate 200mg in 1
Ferrous Fumarate 27mg in 1
Zinc Oxide 25mg in 1
Cupric Oxide 2mg in 1

INACTIVE INGREDIENT(S):

Hypromellose, Unspecified
Magnesium Stearate
Maltodextrin
Microcrystalline Cellulose
Polyethylene Glycol 400
Stearic Acid
Titanium Dioxide
FD&C Blue NO. 2
FD&C Red NO. 40
FD&C Yellow NO. 6

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.

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%

Section 42229-5 (42229-5)

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Section 51945-4 (51945-4)

DRUG: Prenatal Plus Vitamins

GENERIC: prenatal with ferrous fumarate and folic acid

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-4258-0

COLOR: brown

SHAPE: OVAL

SCORE: No score

SIZE: 9 mm

IMPRINT: P;5

PACKAGING: 100 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

Vitamin A Acetate 924ug in 1
Beta Carotene 276ug in 1
Ascorbic Acid 120mg in 1
Cholecalciferol 10ug in 1
.Alpha.-TocopheroL Acetate, DL- 10mg in 1
Thiamine Mononitrate 1.84mg in 1
Riboflavin 3mg in 1
Niacinamide 20mg in 1
Pyridoxine Hydrochloride 10mg in 1
Folic Acid 1667ug in 1
Cyanocobalamin 12ug in 1
Calcium Carbonate 200mg in 1
Ferrous Fumarate 27mg in 1
Zinc Oxide 25mg in 1
Cupric Oxide 2mg in 1

INACTIVE INGREDIENT(S):

Hypromellose, Unspecified
Magnesium Stearate
Maltodextrin
Microcrystalline Cellulose
Polyethylene Glycol 400
Stearic Acid
Titanium Dioxide
FD&C Blue NO. 2
FD&C Red NO. 40
FD&C Yellow NO. 6

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)

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.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762", "51945-4": "DRUG: Prenatal Plus Vitamins GENERIC: prenatal with ferrous fumarate and folic acid DOSAGE: TABLET ADMINSTRATION: ORAL NDC: 70518-4258-0 COLOR: brown SHAPE: OVAL SCORE: No score SIZE: 9 mm IMPRINT: P;5 PACKAGING: 100 in 1 BOTTLE, PLASTIC ACTIVE INGREDIENT(S): Vitamin A Acetate 924ug in 1 Beta Carotene 276ug in 1 Ascorbic Acid 120mg in 1 Cholecalciferol 10ug in 1 .Alpha.-TocopheroL Acetate, DL- 10mg in 1 Thiamine Mononitrate 1.84mg in 1 Riboflavin 3mg in 1 Niacinamide 20mg in 1 Pyridoxine Hydrochloride 10mg in 1 Folic Acid 1667ug in 1 Cyanocobalamin 12ug in 1 Calcium Carbonate 200mg in 1 Ferrous Fumarate 27mg in 1 Zinc Oxide 25mg in 1 Cupric Oxide 2mg in 1 INACTIVE INGREDIENT(S): Hypromellose, Unspecified Magnesium Stearate Maltodextrin Microcrystalline Cellulose Polyethylene Glycol 400 Stearic Acid Titanium Dioxide FD&C Blue NO. 2 FD&C Red NO. 40 FD&C Yellow NO. 6", "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.", "Description": "Prenatal Plus Vitamins is a prescription folic acid containing dietary vitamin and mineral supplement for women before, during and after pregnancy."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:49:58.581929 · Updated: 2026-03-14T22:35:24.342953