Poly-Vi-Sol

Manufacturer
Central Texas Community Health Centers | Mead Johnson & Company, LLC
Effective date
2017-10-20
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:48:38

Label at a glance#

ProductPoly-Vi-Sol
Active ingredientVitamin A, Vitamin D, .ALPHA.-TOCOPHEROL, THIAMINE, Riboflavin, Niacin, PYRIDOXINE, CYANOCOBALAMIN
Label structure13 sections

Label contents#

Full prescribing information#

HEALTH CLAIM SECTION

Liquid multivitamin supplement

Last updated: Tuesday, November 18, 2014

Indication

STATEMENT OF IDENTITY SECTION

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

HEALTH CLAIM SECTION

  • 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

HEALTH CLAIM SECTION

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

HEALTH CLAIM SECTION

  • 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

HEALTH CLAIM SECTION

  • 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

HEALTH CLAIM SECTION

  • 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

DOSAGE & ADMINISTRATION SECTION

  • 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

HEALTH CLAIM SECTION

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

• Precautions

SAFE HANDLING WARNING SECTION

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

• References

HEALTH CLAIM SECTION

  • 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.
  • Testing was conducted in September 2009 by Mead Johnson Nutrition, Quality Control.

PRINCIPAL DISPLAY PANEL - 50 ML Bottle Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - 50 ML Bottle Box Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
NIACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
VITAMIN A Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-337-01Poly-Vi-Sol1 in 1 BOXLIQUID11
76413-337-01Poly-Vi-Sol50 mL in 1 BOTTLELIQUID501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-337POLY-VI-SOL (VITAMIN A, VITAMIN D, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACIN, PYRIDOXINE, AND CYANOCOBALAMIN) LIQUID [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]12 package rows20171023_1f914273-1e08-4d8a-b950-c503d9f51347.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76413-33776413-337-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML · Source PDF

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.