Label: POLY-VI-SOL- vitamin a, vitamin d, .alpha.-tocopherol, thiamine, riboflavin, niacin, pyridoxine, and cyanocobalamin liquid

  • NHRIC Code(s): 76413-337-01
  • Packager: Central Texas Community Health Centers
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated October 20, 2017

If you are a consumer or patient please visit this version.

  • HEALTH CLAIM

    Liquid multivitamin supplement

    Last updated: Tuesday, November 18, 2014

  • Indication

    Multivitamin supplementation for infants and children.

    Enfamil Poly-Vi-Sol Liquid Multivitamin Supplement is recommended for infants around 4–6 months of age who are transitioning to solid foods.

  • • Rationale and Special Characteristics

    • Enfamil Poly-Vi-Sol Liquid Multivitamin Supplement has 9 important vitamins in a convenient daily dose. It is an excellent supplement for a child when transitioning to solid foods, during growth spurts and for the picky eater. Enfamil Poly-Vi-Sol Liquid Multivitamin Supplement (without iron) is recommended for children who have sufficient iron in their diet or the possibility of too much.
      The American Academy of Pediatrics (AAP) recommends 400 IU of supplemental vitamin D per day beginning in the first days of life for all breastfed and partially breastfed infants who do not receive at least 1 L of infant formula per day1.
      Enfamil Poly-Vi-Sol Liquid Multivitamin Supplement is does not contain ingredients derived from the most common food allergies: milk, eggs, peanuts, tree nuts, fish, shellfish, soy or wheat.
      Refrigeration is not required.
  • • Nutrients

    Per 1 mL% DV Infants% DV Children under 4 years
    o Note: Enfamil Poly-Vi-Sol Liquid Multivitamin Supplement does not include folic acid
    Vitamin A, IU7505030
    Vitamin D, IU400100100
    Vitamin E, IU510050
    Vitamin C, mg3510088
    Thiamin, mg0.510071
    Riboflavin, mg0.610075
    Niacin, mg810089
    Vitamin B6, mg0.410057
    Vitamin B12, mcg210067
  • • Osmolality

    • When added to 2 fl oz of infant formula or breast milk, 1 mL of Enfamil® Poly-Vi-Sol® increases the osmolality by +160 mOsmol /kg water2. If the resulting osmolality is higher than desired for a particular baby, an option is to add 0.5 mL of the supplement to the feeding twice per day.
  • • Product Form

    • Enfamil Poly-Vi-Sol Liquid Multivitamin Supplement is available as drops in 50 mL bottles.

    Item #: 040265
    Description: With Dropper
    Unit Size: 50 mL
    Cal./Unit: N/A
    Prod. Yield / Unit (fl oz): N/A
    Case: 12 bottles per case
    Reimbursement Code: 00087-040203

    Usual Daily Dose

    Drops: 1.0 mL

  • • Composition

    • Ingredients: Glycerin, water, ascorbic acid, vitamin E succinate, niacinamide, polysorbate 80, ferrous sulfate (stabilizer for vitamin B12), caramel color, vitamin A palmitate, thiamin hydrochloride, riboflavin-5-phosphate sodium, vitamin D3, vitamin B6 hydrochloride, natural and artificial flavor, sulfuric acid (antioxidant for iron), vitamin B12, sulfites.
  • • Administration

    • Drops: Now includes an easy-to-use syringe. The syringe is marked with 0.25 mL, 0.5 mL, 0.75 mL and 1.0 mL dose lines. To administer directly, place the syringe in the child's mouth with the tip against the inside of the cheek. A firm pressure on the syringe bulb will deliver the proper dose. A slight excess will remain in the syringe. If preferred, the drops may be slowly mixed with formula, juice, cereal or other food and fed within 1 hour.
  • • Storage

    • Store at room temperature. Refrigeration is not required, but will not harm the drops.
  • • Precautions

    • As with all vitamin products, parents should be cautioned against excessive dosage. The bottle should be kept out of the reach of children.
  • • References

    1. Wagner CL, Greer FR, and the American Academy of Pediatrics Section on Breastfeeding and Committee on Nutrition. Prevention of rickets and vitamin D deficiency in infants, children, and adolescents. Pediatrics. 2008;122:1142-1152.
    2.
    Testing was conducted in September 2009 by Mead Johnson Nutrition, Quality Control.
  • HEALTH CLAIM

    Above information found at:

    Enfamil Poly-Vi-Sol. On Mead-Johnson Nutrition website. Available at: https://www.meadjohnson.com/pediatrics/us-en/product-information/products/vitamins/enfamil-poly-vi-sol-drops#references. Accessed 9/7/17.

  • PRINCIPAL DISPLAY PANEL - 50 ML Bottle Box Label

    CommUnityCare Federally Qualified Health Centers

    Poly-Vi-Sol
    #50 ML

    Date:

    Name:
    Dr.

    Take as directed on package.

    1/1/11

    123456

    Poly-Vi-Sol #50 ML NDC 76413-337-01

    Batch: 123456
    Lot: 123456
    Exp: 1/1/11
    MJN

    Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

    Principal Display Panel - 50 ML Bottle Box Label
  • INGREDIENTS AND APPEARANCE
    POLY-VI-SOL 
    vitamin a, vitamin d, .alpha.-tocopherol, thiamine, riboflavin, niacin, pyridoxine, and cyanocobalamin liquid
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:76413-337
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A750 [iU]  in 1 mL
    Vitamin D (UNII: 9VU1KI44GP) (Cholecalciferol - UNII:1C6V77QF41, Vitamin D - UNII:9VU1KI44GP) Vitamin D400 [iU]  in 1 mL
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL5 [iU]  in 1 mL
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE0.5 mg  in 1 mL
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin0.6 mg  in 1 mL
    Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin8 mg  in 1 mL
    PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE0.4 mg  in 1 mL
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN2 ug  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    glycerin (UNII: PDC6A3C0OX)  
    water (UNII: 059QF0KO0R)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    sulfuric acid (UNII: O40UQP6WCF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:76413-337-011 in 1 BOX
    150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT01/01/2009
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    Labeler - Central Texas Community Health Centers (079674019)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Texas Community Health Centers079674019REPACK, RELABEL
    Establishment
    NameAddressID/FEIBusiness Operations
    Mead Johnson & Company, LLC006370092MANUFACTURE