Products

    Phenyl-Free® 1

    An iron-fortified infant formula and medical food powder for infants and young children with documented phenylketonuria

    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 young children with documented phenylketonuria (PKU). This product has all other essential amino acids as well as nonessential amino acids, carbohydrates, fats, essential fatty acids, vitamins and minerals. Use under direct and continuing medical supervision.

    Ingredients

    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).

    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.

    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.

    AMINO ACID COMPOSITION

    ESSENTIAL AMINO ACIDS

    mg/100 g powder

    Histidine

    410

    Isoleucine

    1150

    Leucine

    2100

    Lysine

    1300

    Methionine

    360

    Cysteine

    240

    Phenylalanine

    0

    Tyrosine

    1600

    Threonine

    750

    Tryptophan

    290

    Valine

    1250

    NONESSENTIAL AMINO ACIDS

    mg/100 g powder

    Arginine

    970

    Alanine

    1070

    Aspartic Acid

    1280

    Glutamine

    2600

    Glycine

    580

    Proline

    1280

    Serine

    630

    Product Forms and Ordering Information

    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

    Phenyl-Free® 1, Powder
    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

    PRODUCT BENEFITS

    Phenyl-Free 1 provides all the essential amino acids appropriate for infants and young children with documented PKU, as well as nonessential amino acids, carbohydrates, fats, essential fatty acids, vitamins and minerals

    • DHA and ARA
    • Phenylalanine-free
    • Has choline, an essential nutrient important for brain development and the normal functioning of cells1,2
    • Increased levels of B vitamins, compared to routine infant formulas, for cofactor production
    • Vitamin and mineral levels meet the U.S. Infant Formula Act requirement per 100 Calories

    Additional product features:

    • Vanilla scent
    • Mixes easily and stays in suspension well
    • Halal

    Letter of Medical Necessity Phenyl-Free 1

    This letter establishes a medical need for Phenyl-Free 1 and might help get your patients' insurance company to reimburse them for the product.

    Increase dietary compliance with motivational interviewing

    Use this toolkit to help incorporate motivational interviewing when counselling your patients and caregivers affected by metabolic disorders.

    Contact Mead Johnson

    Contact a Mead Johnson representative to request information and samples

    Layout:
    Help parents receive Special Supplemental Nutrition Program for Women, Infants, and Children
    Access your state’s medical documentation form to help your patients
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    References

    • 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.
    • Zeisel SH, da Costa KA. Choline: an essential nutrient for public health. NutrRev. 2009;67:615-623.
    • Fomon SJ, Ziegler EE. Renal solute load and potential renal solute load in infancy. J Pediatr. 1999;134:11-14.