PRENATAL VITAMINS PLUS LOW IRON- prenatal with ferrous fum and folic acid tablet

Prenatal Vitamins Plus Low Iron by

Drug Labeling and Warnings

Prenatal Vitamins Plus Low Iron by is a Prescription medication manufactured, distributed, or labeled by Patrin Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BOXED WARNING

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

DESCRIPTION

Each Tablet Contains:	Amount Per Tablet	% Daily Value
Vitamin A (from Acetate and Beta Carotene)	4000 IU	80%
Vitamin C (Ascorbic Acid)	120 mg	200%
Vitamin D-3 (Cholecalciferol)	400 IU	100%
Vitamin E (dl-Alpha Tocopheryl Acetate)	22 mg	73%
Vitamin B-1(Thiamine Mononitrate)	1.84 mg	123%
Vitamin B-2 (Riboflavin)	3 mg	176%
Niacin (as Niacinamide)	20 mg	100%
Vitamin B-6 (Pyridoxine HCI)	10 mg	500%
Folic Acid	1 mg	200%
Vitamin B-12 (Cyanocobalamin)	12 mcg	200%
Calcium (from Calcium Carbonate)	200 mg	20%
Iron (Ferrous Fumarate)	27 mg	150%
Zinc (Zinc Oxide)	25mg	167%
Copper (Cupric Oxide)	2 mg	100%

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.

BOXED WARNING

(What is this?)

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.

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 800-936-3088
Rev 01.0313

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRENATAL VITAMINS PLUS LOW IRON 
prenatal with ferrous fum and folic acid tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 39328-106
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	3080 [iU]
BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J)	BETA CAROTENE	920 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	22 mg
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	1.84 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A)	NIACIN	20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	200 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	27 mg
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	25 mg
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	2 mg

Inactive Ingredients
Ingredient Name	Strength
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
ACACIA (UNII: 5C5403N26O)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
METHYLCELLULOSE (100 MPA.S) (UNII: 4GFU244C4J)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYETHYLENE GLYCOL, UNSPECIFIED (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)

Product Characteristics
Color	brown (Beige)	Score	no score
Shape	OVAL (OVAL)	Size	9mm
Flavor		Imprint Code	P;5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 39328-106-10	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2013
2	NDC: 39328-106-50	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		04/01/2013

Labeler - Patrin Pharma, Inc. (806841677)