PRENATAL PLUS IRON- multivitamin/multimineral supplement tablet, film coated 
Major Pharmaceuticals

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

DESCRIPTION

Prenatal Plus Iron Tablet is caplet shaped, film coated tablet debossed CIS 28, and provides 10 vitamins and 4 minerals to supplement the diet before, during and after pregnancy.

Each Prenatal Plus tablet Contains:

Vitamin A (Acetate and Beta Carotene)............................................4000 I.U.

Vitamin C (Ascorbic acid)..................................................................120 mg

Vitamin D-3 (Cholecalciferol)...............................................................400 I.U.

Vitamin E (dl- Alpha Tocopheryl Acetate)...........................................22 I.U.

Thiamine (Vitamin B-1 from Thiamine Mononitrate...............................1.84 mg

Riboflavin (Vitamin B-2).......................................................................3 mg

Niacin(Niacinamide).............................................................................20 mg

Vitamin B-6 (Pyridoxine HCl)...............................................................10 mg

Folic Acid.............................................................................................1 mg

Vitamin B-12 (Cyanocobalamin)..........................................................12 mcg

Calcium (Calcium Carbonate)...............................................................200 mg

Iron (Carbonyl Iron)..............................................................................29 mg

Zinc (Zinc Oxide).................................................................................25 mg

Copper (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 Yello # 6 lake, Glucose, Gum Acacia, Hypromellose, Magnesium Stearate, Maize Starch, Maltodextrin, Methylcellulose, Microcrystalline Cellulose, Mineral Oil, Mono-and di-glycerides, Polyethyelene Glycol, Pregelatinized Corn Starch, Silicon Dioxide, Sorbic Acid, Soy Protein, Stearic Acid, Sucrose, Titanium Dioxide, Tricalcium Phosphate

INDICATIONS

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 a physician.

WARNING

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 progesses.

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 Yello No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

STORAGE

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

HOW SUPPLIED

NDC 0904-5339-60 plastic bottle containing 100 Tablets.

PRINCIPAL DISPLAY PANEL

NDC 0904-5339-60

Prenatal Plus
Iron Tablets
Multivitamin/Multimineral
Supplement

For Use Before, During and
After Pregnancy.

Rx only

100 Tablets

Major®
Pharmaceuticals

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY
REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.

Keep this and all medication out of reach of children.

Do not use if imprinted seal under cap is broken or missing

Manufactured By: Cispharma, Inc, Cranbury, NJ 08512
Distributed By: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150 USA

bottle label
PRENATAL PLUS IRON 
multivitamin/multimineral supplement tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0904-5339
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A3080 [iU]
.BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE920 [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) THIAMINE ION1.84 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE10 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) CALCIUM CATION200 mg
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION29 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
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)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ETHYLCELLULOSE (100 MPA.S) (UNII: 47MLB0F1MV)  
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
ACACIA (UNII: 5C5403N26O)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
METHYLCELLULOSE (1500 MPA.S) (UNII: P0NTE48364)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
METHYL SORBATE (UNII: J3048615R1)  
SOY PROTEIN (UNII: R44IWB3RN5)  
Product Characteristics
ColorYELLOW (TAN) Scoreno score
ShapeCAPSULESize18mm
FlavorImprint Code CIS28
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5339-60100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/07/201108/18/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/07/201108/18/2016
Labeler - Major Pharmaceuticals (191427277)
Registrant - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
Major Pharmaceuticals191427277REPACK(0904-5339)

Revised: 11/2017
 
Major Pharmaceuticals