PRENATAL PLUS- vitamin a, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, zinc oxide, and cupric oxide tablet

Prenatal Plus by

Drug Labeling and Warnings

Prenatal Plus by is a Prescription medication manufactured, distributed, or labeled by Nationwide Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

• Each Tablet Contains: VITAMINS: Amount per Tablet
• Vitamin A (from Acetate and Beta Carotene): 4000 IU
• Vitamin C (Ascorbic Acid): 120 mg
• Vitamin D-3 (Cholecalciferol): 400 IU
• Vitamin E (dl-Alpha Tocopheryl Acetate): 22 IU
• Thiamine (Vitamin B-1 from Thiamine Mononitrate): 1.84 mg
• Riboflavin (Vitamin B-2): 3 mg
• Niacin (as Niacinamide): 20 mg
• Vitamin B-6 (from Pyridoxine HCl): 10 mg
• Folic Acid: 1 mg
• Vitamin B-12 (Cyanocobalamin): 12 mcg
• Calcium (from Calcium Carbonate): 200 mg
• Iron (from Carbonyl Iron): 29 mg
• Zinc (from Zinc Oxide): 25 mg
• Copper (from Cupric Oxide): 2 mg

Other Ingredients

Ascorbyl Palmitate, Citric Acid anhydrous, DL- alpha Tocopherol, Ethylcellulose, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow #5 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.

Indication

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

Dosage

As a dietary adjunct before, during and after pregnancy, take one tablet daily with a meal, or as directed by physician.

BOXED WARNING

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WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.

Precautions

Folic acid may partially correct the hematological damage due to Vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses.

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

STORAGE AND HANDLING

Store at room temperature. Dispense in a well closed light-resistant container, with a child resistant cap.

SPL UNCLASSIFIED SECTION

CALL YOUR DOCTOR FOR MEDICAL ADVISE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 (TOLL FREE).

Keep this and all medication out of the reach of children.

Do not use if imprinted Safety Seal under cap is broken or missing.

Distributed by: Nationwide Laboratories, Iselin NJ 08830

Lot No.: Exp. Date: Rev. 7/12

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

Nationwide Laboratories LLC

NDC: 42937-705-10

Prenatal Plus
Iron Tablets

Multivitamin/Multimineral
Supplement

For Use Before, During
and After Pregnancy.

Rx only

100 Tablets

INGREDIENTS AND APPEARANCE

PRENATAL PLUS 
vitamin a, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, zinc oxide, and cupric oxide tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 42937-705
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T)	Vitamin A	4000 [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 [iU]
Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J)	Thiamine	1.84 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR)	Riboflavin	3 mg
Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4)	Niacinamide	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, Carbonate Ion - UNII:7UJQ5OPE7D)	Calcium Carbonate	200 mg
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7)	Iron	29 mg
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	25 mg
Cupric Oxide (UNII: V1XJQ704R4) (Cupric Cation - UNII:8CBV67279L)	Cupric Cation	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)
Aluminum Oxide (UNII: LMI26O6933)
FD&C Red No. 40 (UNII: WZB9127XOA)
FD&C Yellow No. 5 (UNII: I753WB2F1M)
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)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
Mineral Oil (UNII: T5L8T28FGP)
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	YELLOW (Tan)	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	CIS;28
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42937-705-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2011
2	NDC: 42937-705-16	250 in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2011
3	NDC: 42937-705-18	500 in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		06/01/2011

Labeler - Nationwide Laboratories (078366153)