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

Poly-Vi-Sol by

Drug Labeling and Warnings

Poly-Vi-Sol by is a Other medication manufactured, distributed, or labeled by Central Texas Community Health Centers, Mead Johnson & Company, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, 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.

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.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:76413-337
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T)	Vitamin A	750 [iU]  in 1 mL
Vitamin D (UNII: 9VU1KI44GP) (Cholecalciferol - UNII:1C6V77QF41, Vitamin D - UNII:9VU1KI44GP)	Vitamin D	400 [iU]  in 1 mL
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL	5 [iU]  in 1 mL
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	0.5 mg  in 1 mL
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR)	Riboflavin	0.6 mg  in 1 mL
Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A)	Niacin	8 mg  in 1 mL
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	0.4 mg  in 1 mL
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	2 ug  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
glycerin (UNII: PDC6A3C0OX)
water (UNII: 059QF0KO0R)
polysorbate 80 (UNII: 6OZP39ZG8H)
sulfuric acid (UNII: O40UQP6WCF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:76413-337-01	1 in 1 BOX
1		50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		01/01/2009

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color

Labeler - Central Texas Community Health Centers (079674019)

Establishment
Name	Address	ID/FEI	Business Operations
Central Texas Community Health Centers		079674019	REPACK, RELABEL

Establishment
Name	Address	ID/FEI	Business Operations
Mead Johnson & Company, LLC		006370092	MANUFACTURE