Label: PRENATAL VITAMINS PLUS LOW IRON- prenatal with ferrous fum and folic acid tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 28, 2020

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  • BOXED WARNING (What is this?)

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

  • DESCRIPTION

    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 & USAGE

    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.

  • DOSAGE & ADMINISTRATION

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

  • CONTRAINDICATIONS

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

  • PRECAUTIONS

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

  • BOXED WARNING (What is this?)

    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.

  • STORAGE AND HANDLING

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

    Repackaged and Distributed By:

    Remedy Repack, Inc.

    625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

  • HOW SUPPLIED

    NDC: 70518-2746-00

    PACKAGING: 30 in 1 BLISTER PACK

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

    Repackaged and Distributed By:

    Remedy Repack, Inc.

    625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

  • PRINCIPAL DISPLAY PANEL

    DRUG: Prenatal Vitamins Plus Low Iron

    GENERIC: Prenatal with Ferrous Fum and Folic Acid

    DOSAGE: TABLET

    ADMINSTRATION: ORAL

    NDC: 70518-2746-0

    COLOR: brown

    SHAPE: OVAL

    SCORE: No score

    SIZE: 9 mm

    IMPRINT: P;5

    PACKAGING: 30 in 1 BLISTER PACK

    ACTIVE INGREDIENT(S):

    • VITAMIN A ACETATE 3080[iU] in 1
    • BETA CAROTENE 920[iU] in 1
    • ASCORBIC ACID 120mg in 1
    • CHOLECALCIFEROL 400[iU] in 1
    • .ALPHA.-TOCOPHEROL ACETATE, DL- 22mg in 1
    • THIAMINE 1.84mg in 1
    • RIBOFLAVIN 3mg in 1
    • NIACIN 20mg in 1
    • PYRIDOXINE HYDROCHLORIDE 10mg in 1
    • FOLIC ACID 1mg in 1
    • CYANOCOBALAMIN 12ug in 1
    • CALCIUM CARBONATE 200mg in 1
    • IRON 27mg in 1
    • ZINC 25mg in 1
    • COPPER 2mg in 1

    INACTIVE INGREDIENT(S):

    • TRICALCIUM PHOSPHATE
    • SUCROSE
    • STEARIC ACID
    • SOY PROTEIN
    • SORBIC ACID
    • SILICON DIOXIDE
    • POLYETHYLENE GLYCOL, UNSPECIFIED
    • GLYCERYL MONOSTEARATE
    • MINERAL OIL
    • MICROCRYSTALLINE CELLULOSE
    • METHYLCELLULOSE (100 MPA.S)
    • TITANIUM DIOXIDE
    • MALTODEXTRIN
    • MAGNESIUM STEARATE
    • HYPROMELLOSE, UNSPECIFIED
    • ACACIA
    • DEXTROSE, UNSPECIFIED FORM
    • FD&C YELLOW NO. 6
    • FD&C RED NO. 40
    • FD&C BLUE NO. 2
    • ETHYLCELLULOSE, UNSPECIFIED
    • .ALPHA.-TOCOPHEROL, DL-
    • ANHYDROUS CITRIC ACID
    • STARCH, CORN
    • ASCORBYL PALMITATE

    MM1

  • INGREDIENTS AND APPEARANCE
    PRENATAL VITAMINS PLUS LOW IRON 
    prenatal with ferrous fum and folic acid tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70518-2746(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:70518-2746-030 in 1 BLISTER PACK; Type 0: Not a Combination Product05/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/14/2020
    Labeler - REMEDYREPACK INC. (829572556)
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