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

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 VITAMINS PLUS LOW IRON TABLETS

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

Each Tablet Contains:Amount
Per Tablet
% Daily
Value
Vitamin A (from Acetate and Beta Carotene)4000 IU80%
Vitamin C (Ascorbic Acid)120 mg200%
Vitamin D-3 (Cholecalciferol)400 IU100%
Vitamin E (dl-Alpha Tocopheryl Acetate)22 mg73%
Vitamin B-1(Thiamine Mononitrate)1.84 mg123%
Vitamin B-2 (Riboflavin)3 mg176%
Niacin (as Niacinamide)20 mg100%
Vitamin B-6 (Pyridoxine HCI)10 mg500%
Folic Acid1 mg200%
Vitamin B-12 (Cyanocobalamin)12 mcg200%
Calcium (from Calcium Carbonate)200 mg20%
Iron (Ferrous Fumarate)27 mg150%
Zinc (Zinc Oxide)25mg167%
Copper (Cupric Oxide)2 mg100%

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: 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.

Directions: Before, during and after pregnancy, one tablet daily or as directed by a physician.

Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Caution: Folic Acid may partially correct the hematological damage due to Vitamin B-12 deficiency of pernicious anemia while the associated neurological damage progresses.

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.

Store at room temperature, USP. Dispense in a well closed light resistant container.

HOW SUPPLIED

Product: 68151-5878

NDC: 68151-5878-1 1 TABLET in a BLISTER PACK

PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET

Label Image
PRENATAL VITAMINS PLUS LOW IRON 
prenatal with ferrous fum and folic acid tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68151-5878(NDC:39328-106)
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 mg
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.84 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN20 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) CALCIUM CARBONATE200 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON27 mg
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC25 mg
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER2 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)  
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
Colorbrown (Beige) Scoreno score
ShapeOVAL (OVAL) Size9mm
FlavorImprint Code P;5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68151-5878-11 in 1 BLISTER PACK; Type 0: Not a Combination Product12/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other04/01/2013
Labeler - Carilion Materials Management (079239644)
Establishment
NameAddressID/FEIBusiness Operations
Carilion Materials Management079239644REPACK(68151-5878)

Revised: 12/2017
Document Id: 84181497-355d-43d7-8d42-a30d69b97eaa
Set id: 5c1eb2c1-1046-4a4a-939b-5c1043c6ccdd
Version: 2
Effective Time: 20171226
 
Carilion Materials Management