Phenyl-Free® 1

Iron-fortified infant formula and medical food powder for infants and toddlers with phenylketonuria (PKU).

Last Updated: Tuesday, December 26, 2017 - 19:00

Description/Indication

Phenyl-Free 1 is an iron-fortified infant formula and medical food powder that is free of the essential amino acid phenylalanine for infants and toddlers with documented phenylketonuria (PKU). This product provides all other essential amino acids as well as nonessential amino acids, carbohydrate, fat, essential fatty acids, vitamins and minerals. Use under direct and continuing supervision of a doctor.

Product Features:

  • DHA and ARA
  • Phenylalanine-free
  • Vitamin and mineral levels meet the U.S. Infant Formula Act requirement per 100 Calories
  • Increased levels of B vitamins, compared to routine infant formulas, for cofactor production
  • Vanilla scent
  • Mixes easily and stays in suspension well
  • Has choline, an essential nutrient important for brain development and the normal functioning of cells1,2
  • Halal
  • Nutrients
    • Per 100 grams Powder

      Calories

      500

      Protein equivalent, g

      16.2

      Fat, g

      26

      Linoleic acid, mg

      4000

      Carbohydrate, g

      51

      Vitamins/Other Nutrients

      Vitamin A, IU

      1520

      Vitamin D, IU

      380

      Vitamin E, IU

      10

      Vitamin K, mcg

      40

      Thiamin (Vitamin B1), mcg

      1000

      Riboflavin (Vitamin B2), mcg

      1000

      Vitamin B6, mcg

      1000

      Vitamin B12, mcg

      2

      Niacin, mcg

      10000

      Folic acid (Folacin), mcg

      100

      Pantothenic acid, mcg

      3800

      Biotin, mcg

      38

      Vitamin C (Ascorbic acid), mg

      60

      Choline, mg

      124

      Inositol, mg

      86

      Minerals

      Calcium, mg

      660

      Phosphorous, mg

      440

      Magnesium, mg

      66

      Iron, mg

      9.6

      Zinc, mg

      8.6

      Manganese, mcg

      380

      Copper, mcg

      860

      Iodine, mcg

      76

      Selenium, mcg

      14.1

      Sodium, mg

      240

      Potassium, mg

      560

      Chloride, mg

      430

      Product nutrient values and ingredients are subject to change. Please see product label for current information.

      * WARNING: Protein is incomplete since it does not contain the essential amino acid phenylalanine.

      † Determined at 20 Cal/fl oz dilution.

  • Nutrient Facts
    • Protein Equivalent (% Calories)*

      13

      Fat (% Calories)

      47

      Carbohydrate (% Calories)

      40

      Potential Renal Solute Load (mOsm/100 g powder)3

      144

      Osmolality (mOsm/kg water)

      350

      Osmolarity (mOsm/L)

      320

      Lactose-free

      Suitable for someone with lactose intolerance

      * WARNING: Protein is incomplete since it does not contain the essential amino acid phenylalanine.

      † Determined at 20 Cal/fl oz dilution.

  • Product Forms

      Phenyl-Free 1 is available in powder.

      When using this information, please note the following:

      Coding systems and reimbursement allowable rates vary by payer:

      • Medicare Part B uses HCPCS (Healthcare Common Procedure Coding System) to group products
      • Medicaid systems vary by state; some use HCPCS while others use NDC format code or systems of their own—contact your state provider for more information
      • Private health insurance and managed care companies may use HCPCS, NDC format code or their own system—contact your provider for more information


    • Product: Phenyl-Free® 1
      Item #: 892601
      Description: Powder
      Unit Size: 1 lb can
      Calories/Unit: 2270
      Product Yield/Unit (fl oz): Varies
      Case: 6 cans per case
      HCPCS Code: B4162
      NDC Format Code: 00087-5101-72
  • Composition
    • Ingredients: Corn syrup solids, vegetable oil (palm olein oil, coconut oil, soy oil, high oleic sunflower oil), amino acids (L-glutamine, L-leucine, potassium aspartate, L-lysine hydrochloride, L-tyrosine, L-proline, L-valine, L-isoleucine, L-alanine, L-arginine, L-threonine, L-serine, glycine, L-histidine, L-methionine, L-tryptophan, L-cystine), modified corn starch, sugar, calcium phosphate and less than 1%: Mortierella alpina oil*, Crypthecodinium cohnii oil, ethyl vanillin, sodium citrate, potassium citrate, magnesium oxide, ferrous sulfate, potassium chloride, zinc sulfate, cupric sulfate, manganese sulfate, sodium iodide, sodium selenite, choline chloride, inositol, ascorbic acid, niacinamide, calcium pantothenate, vitamin B6 hydrochloride, thiamin hydrochloride, riboflavin, vitamin D3, folic acid, biotin, vitamin K1, vitamin E acetate, vitamin A palmitate, vitamin B12, taurine, L-carnitine.

      * A source of arachidonic acid (ARA).

      † A source of docosahexaenoic acid (DHA).

  • Amino Acid Composition
    • ESSENTIAL AMINO ACIDS
      mg/100 g powder
      Histidine410
      Isoleucine1150
      Leucine2100
      Lysine1300
      Methionine360
      Cysteine240
      Phenylalanine0
      Tyrosine1600
      Threonine750
      Tryptophan290
      Valine1250
      NONESSENTIAL AMINO ACIDS
      mg/100 g powder
      Arginine970
      Alanine1070
      Aspartic Acid1280
      Glutamic Acid2600
      Glycine580
      Proline1280
      Serine630
      Tyrosine1600
      Threonine750
      Tryptophan290
      Valine1250
  • Preparation of Feedings
    • Powder

      The baby’s health depends on carefully following the instructions below. Use only as directed by a medical professional. Proper hygiene, preparation, dilution, use and storage are important when preparing infant formula. Powdered infant formulas are not sterile and should NOT be fed to premature infants or infants who might have immune problems unless directed and supervised by a doctor. Discuss with parents which formula is appropriate for the baby.

      Discuss with parents whether they need to use cooled, boiled water for mixing and whether they need to boil clean utensils, bottles and nipples in water before use.

      The medical professional will provide instructions for the correct amounts of water and powder. Pour the required amount of water into the bottle/container. Add the correct amount of powder, cap the bottle/container and shake vigorously.

      If instructed to use the scoop in the can, each unpacked, level scoop delivers approximately 4.5 g of powder. Store DRY scoop in can.

      Failure to follow these instructions could result in severe harm. Once prepared, infant formula can spoil quickly. Either feed immediately or cover and store in refrigerator at 35–40°F (2–4°C) for no longer than 24 hours. Do not use prepared formula if it is unrefrigerated for more than a total of 2 hours. Do not freeze prepared formula. After feeding begins, use formula within 1 hour or discard.

      WARNING: Do not use a microwave oven to warm formula. Serious burns may result.

      Refer to the product label for the most accurate information.

      CAUTION: Mead Johnson Nutrition Phenyl-Free® 1 is to be used only in the dietary management of infants and young children with documented phenylketonuria while under direct and continuing medical supervision.

      WARNING: This product is nutritionally incomplete. Care must be taken to provide enough phenylalanine to support growth using other foods with this amino acid as required. Medical professionals must carefully and constantly supervise use of Phenyl-Free 1 with other foods and liquids and adjust the diet based on frequent blood tests.

      WARNING: Not for parenteral (I.V.) use.

  • References
      1. Food and Nutrition Board, Institute of Medicine, Choline. In: Dietary References Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline. Washington, DC: National Academies Press; 1998:390-422.
      2. Zeisel SH, da Costa KA. Choline: an essential nutrient for public health. Nutr Rev. 2009;67:615-623.
      3. Fomon SJ, Ziegler EE. Renal solute load and potential renal solute load in infancy. J Pediatr. 1999;134:11-14.
  • Consumer Reviews