Poly-Vi-Sol: Package Insert and Label Information

POLY-VI-SOL- vitamin a, vitamin d, .alpha.-tocopherol, thiamine, riboflavin, niacin, pyridoxine and cyanocobalamin liquid
Central Texas Community Health Centers

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, IU 750 50 30
Vitamin D, IU 400 100 100
Vitamin E, IU 5 100 50
Vitamin C, mg 35 100 88
Thiamin, mg 0.5 100 71
Riboflavin, mg 0.6 100 75
Niacin, mg 8 100 89
Vitamin B6 , mg 0.4 100 57
Vitamin B12 , mcg 2 100 67

• 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.

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
(click image for full-size original)
POLY-VI-SOL
vitamin a, vitamin d, .alpha.-tocopherol, thiamine, riboflavin, niacin, pyridoxine, and cyanocobalamin liquid
Product Information
Product Type Item Code (Source) NDC:76413-337
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Vitamin A (Vitamin A) Vitamin A 750 [iU] in 1 mL
Vitamin D (Cholecalciferol and Vitamin D) Vitamin D 400 [iU] in 1 mL
.ALPHA.-TOCOPHEROL (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL 5 [iU] in 1 mL
THIAMINE (THIAMINE ION) THIAMINE 0.5 mg in 1 mL
Riboflavin (Riboflavin) Riboflavin 0.6 mg in 1 mL
Niacin (Niacin) Niacin 8 mg in 1 mL
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 0.4 mg in 1 mL
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 2 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
glycerin
water
polysorbate 80
sulfuric acid
Product Characteristics
Color YELLOW (caramel coloring) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76413-337-01 1 BOTTLE in 1 BOX contains a BOTTLE
1 50 mL in 1 BOTTLE This package is contained within the BOX (76413-337-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 01/01/2009
Labeler — Central Texas Community Health Centers (079674019)
Establishment
Name Address ID/FEI Operations
Central Texas Community Health Centers 079674019 REPACK, RELABEL
Establishment
Name Address ID/FEI Operations
Mead Johnson & Company, LLC 006370092 MANUFACTURE

Revised: 10/2017 Central Texas Community Health Centers

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.