Prenatal Vitamins Plus Low Iron

Prenatal Vitamins Plus Low Iron
SPL v3
SPL
SPL Set ID 59c5c1a4-3f42-441a-b842-903f9bab346f
Route
ORAL
Published
Effective Date 2022-01-13
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 2013-04-01 Until 2021-11-04

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

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.

Principal Display Panel 100 Tablet Bottle Label

Rx

Only

NDC 39328-106-10

Prenatal Plus

Vitamins

27 mg Fe & 1 mg FA

Before, During and After

Pregnancy

100 tablets

Made in the USA

PATRIN

PHARMA


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.

Principal Display Panel 100 Tablet Bottle Label (PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label)

Rx

Only

NDC 39328-106-10

Prenatal Plus

Vitamins

27 mg Fe & 1 mg FA

Before, During and After

Pregnancy

100 tablets

Made in the USA

PATRIN

PHARMA


Advanced Ingredient Data


Raw Label Data

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