Label: PRENATAL VITAMINS PLUS LOW IRON- prenatal with ferrous fum and folic acid tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 68151-5878-1 - Packager: Carilion Materials Management
- This is a repackaged label.
- Source NDC Code(s): 39328-106
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated December 26, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- BOXED WARNING (What is this?)
-
DESCRIPTION
Each Tablet Contains: Amount
Per Tablet% Daily
ValueVitamin 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
- DOSAGE & ADMINISTRATION
- CONTRAINDICATIONS
- PRECAUTIONS
- BOXED WARNING (What is this?)
- STORAGE AND HANDLING
- HOW SUPPLIED
- PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET
-
INGREDIENTS AND APPEARANCE
PRENATAL VITAMINS PLUS LOW IRON
prenatal with ferrous fum and folic acid tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-5878(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:68151-5878-1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 12/26/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 04/01/2013 Labeler - Carilion Materials Management (079239644) Establishment Name Address ID/FEI Business Operations Carilion Materials Management 079239644 REPACK(68151-5878)
