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 
Nationwide Laboratories

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Prenatal Plus
Iron Tablets

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 Acid1 mg
Vitamin B-12 (Cyanocobalamin)12 mcg
MINERALS:
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.

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.

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

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

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42937-705
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A4000 [iU]
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid120 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol400 [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) Thiamine1.84 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin3 mg
Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide20 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride10 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin12 ug
Calcium Carbonate (UNII: H0G9379FGK) (Calcium Cation - UNII:2M83C4R6ZB, Carbonate Ion - UNII:7UJQ5OPE7D) Calcium Carbonate200 mg
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron29 mg
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide25 mg
Cupric Oxide (UNII: V1XJQ704R4) (Cupric Cation - UNII:8CBV67279L) Cupric Cation2 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (Tan) Scoreno score
ShapeOVALSize18mm
FlavorImprint Code CIS;28
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42937-705-10100 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
2NDC:42937-705-16250 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
3NDC:42937-705-18500 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER06/01/2011
Labeler - Nationwide Laboratories (078366153)

Revised: 3/2020
Document Id: ed67c3cd-b0d8-4a62-90ad-1cf5312de23f
Set id: d358a991-e17a-47ff-beeb-8ef0aea56944
Version: 2
Effective Time: 20200304
 
Nationwide Laboratories