• PurAmino™ Toddler

PurAmino™ Toddler

Hypoallergenic amino acid-based Medical Food.

Last Updated: Monday, December 18, 2017

  • Description/Indication
    • PurAmino Toddler is a 30 Cal/fl oz, iron-fortified, hypoallergenic, amino acid-based toddler medical food for the dietary management of toddlers with severe cow’s milk protein allergy, not effectively managed by an extensively hydrolyzed formula. PurAmino Toddler is also indicated for the dietary management of toddlers with multiple food protein allergies. It may also be suitable for conditions requiring an elemental diet such as protein maldigestion, malabsorption, short bowel syndrome and eosinophilic esophagitis.

      Long-Term Usage:

      PurAmino Toddler is designed to provide a major source of nutrition for toddlers age 1 year and up. In cases of severe and multiple food allergies or intolerances, PurAmino Toddler is sometimes continued as a milk substitute in the diet of children. This and similar supplemental use of PurAmino Toddler in the diet may make a significant contribution to maintenance of good nutrition in such patients.

      When PurAmino Toddler is used as a milk substitute, the total calcium content of the diet should be assessed.

      Extended use of PurAmino Toddler (or other toddler formulas) is most appropriately monitored by physicians and nutritionists on a case-by-case basis.

  • Product Features
      • Hypoallergenic, 100% free amino acids as nitrogen source
      • The only amino acid toddler formula that has DHA and ARA, important nutrients that help promote brain and eye development
      • Formulated with 33% MCT oil to help facilitate fat absorption
      • Has calcium and protein for growing toddlers
      • Lactose-free
      • Kosher, halal
  • Nutrients
    • (Normal Dilution) Per 100 KCal
      (3.3 fl oz)
      Per 100 mL Per 100 grams
      Powder (500 Cal)
      Protein equivalent, g 2.8 2.8 13.9
      Fat, g 5.3 5.4 26
      Linoleic acid, mg 860 870 4300
      Carbohydrate, g 10.6 10.7 53
      Water, g 133 134 1.82
      (Normal Dilution) Per 100 KCal
      (3.3 fl oz)
      Per 100 mL Per 100 grams
      Powder (500 Cal)
      Vitamins/Other Nutrients
      Vitamin A, IU 300 300 1490
      Vitamin D, IU 50 51 250
      Vitamin E, IU 2 2 9.9
      Vitamin K, mcg 9 9.1 45
      Thiamin (Vitamin B1), mcg 80 81 400
      Riboflavin (Vitamin B2), mcg 90 91 450
      Vitamin B6, mcg 60 61 300
      Vitamin B12, mcg 0.3 0.3 1.49
      Niacin, mcg 1000 1010 5000
      Folic acid (Folacin), mcg 16 16.2 80
      Pantothenic acid, mcg 500 510 2500
      Biotin, mcg 3 3 14.9
      Vitamin C (Ascorbic acid), mg 12 12.1 60
      Choline, mg 24 24 119
      Inositol, mg 17 17.2 85
      (Normal Dilution) Per 100 KCal
      (3.3 fl oz)
      Per 100 mL Per 100 grams
      Powder (500 Cal)
      Calcium, mg 94 95 470
      Phosphorus, mg 52 53 260
      Magnesium, mg 11 11.1 55
      Iron, mg 1.8 1.82 9
      Zinc, mg 1 1.01 5
      Manganese, mcg 25 25 124
      Copper, mcg 75 76 370
      Iodine, mcg 15 15.2 75
      Selenium, mcg 2.8 2.8 13.9
      Sodium, mg 47 47 230
      Potassium, mg 110 111 550
      Chloride, mg 86 87 430
  • Nutrient Facts
    • Nutrient Density 30 Calories/fl oz
      Protein (% Calories) 11
      Fat (% Calories) 47
      Carbohydrate (% Calories) 42
      Potential Renal Solute Load (mOsm/100 Calories)1 25
      Potential Renal Solute Load (mOsm/100 mL)1 25
      Osmolality (mOsm/kg water) Not Available
      Osmolarity (mOsm/L) Not Available
      Lactose-Free Yes
  • Product Forms
    • PurAmino Toddler is available in powder.

      Item #: 157301
      Description: Powder
      Unit Size: 14.1 oz can (400 g)
      Cal/Unit: 1980
      Prod. Yield/Unit (fl oz): 66
      Case: 4 cans per case
      Reimbursement Code: 00087-511732

  • Composition
    • Ingredients: Corn syrup solids (49%), amino acids (L-aspartic acid, L-leucine, L-lysine hydrochloride, L-proline, L-alanine, L-valine, monosodium glutamate, L-isoleucine, L-serine, L-threonine, L-tyrosine, L-arginine, L-phenylalanine, glycine, L-cystine, L-histidine, L-tryptophan, L-methionine) (17%), high oleic sunflower oil (10%), medium chain triglycerides (MCT) oil (9%), soy oil (8%), modified tapioca starch (3%) and less than 2%: Mortierella alpina oil*, Crypthecodinium cohnii oil, choline chloride, inositol, ascorbic acid, niacinamide, calcium pantothenate, riboflavin, thiamin hydrochloride, vitamin B6 hydrochloride, vitamin D3, folic acid, vitamin K1, biotin, taurine, vitamin E acetate, L-carnitine, vitamin A palmitate, vitamin B12, calcium phosphate, potassium citrate, calcium citrate, sodium citrate, potassium chloride, calcium hydroxide, magnesium phosphate, ferrous sulfate, zinc sulfate, cupric sulfate, manganese sulfate, sodium iodide, sodium selenite.

      * A source of arachidonic acid (ARA). † A source of docosahexaenoic acid (DHA).

  • Potential Allergens
    • PurAmino Toddler contains soy oil. PurAmino Toddler is hypoallergenic.

  • Preparation of Feedings
    • 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.

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

      Refer to the product label for the most accurate information.


      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.

      1. Wash hands thoroughly with soap and water before preparing formula.
      2. Pour desired amount of water into bottle. Add powder.
      3. Cap bottle and SHAKE WELL.

      The medical professional will provide the correct amount of powder to mix with water for consumption. It is important to follow the directions below.

      Measure the correct amount of water into a suitable container for mixing. Then add the required amount of PurAmino Toddler powder. Mix well until blended.

      Consume the prepared beverage immediately or cover and refrigerate. Use within 48 hours of preparation. Mix before drinking.

      ‡ If instructed to use the scoop in the can to make 30 Cal/fl oz feedings: For every 1 fl oz of water, 1 unpacked level scoop of powder (7.2 g) will make approximately 1.2 fl oz of prepared formula. Add 5 unpacked level scoops (36 g) of powder to 5 fl oz of water to make 6 fl oz of prepared product. Add 7 unpacked level scoops (50.4 g) to 7 fl oz of water to make 8.4 fl oz of prepared product. Store DRY scoop in can.

  • Product Characteristics
    • Fat

      The fat content in PurAmino Toddler is 47% of total calories. The fat blend consists of approximately:

      • 34.5% high oleic sunflower oil
      • 33% MCT oil
      • 30% soy oil
      • 2.5% single-cell oil blend of docosahexaenoic acid (DHA) and arachidonic acid (ARA)

      DHA and ARA

      PurAmino Toddler has DHA and ARA, two nutrients also found in breast milk that are important building blocks for a baby's brain and eyes1,2–4.


      Protein provides 11% of total calories in PurAmino Toddler. The protein source is an amino acid premix composed of 100% free amino acids in the following amounts:

      Amino Acid

      Amino Acid mg Per 100 Calories mg Per 100 Grams
      Arginine 148 740
      Histidine 73 360
      Isoleucine 190 950
      Leucine 340 1710
      Amino Acid mg Per 100 Calories mg Per 100 Grams
      Lysine 220 1110
      Methionine 64 320
      Cysteine 73 360
      Phenylalanine 140 700
      Tyrosine 151 750
      Threonine 171 850
      Tryptophan 67 330
      Valine 210 1060
      Alanine 270 1350
      Aspartic Acid 560 2800
      Glutamic Acid 168 830
      Glycine 73 360
      Proline 280 1390
      Serine 171 850


      Carbohydrate provides 42% of total calories in PurAmino Toddler and the product is suitable for someone with lactose intolerance. The carbohydrate blend is corn syrup solids and modified tapioca starch. The carbohydrates in PurAmino Toddler are readily digested6 and well tolerated by infants whose ability to digest other carbohydrates, such as lactose and sucrose, may be an issue. The production of corn syrup solids includes filtration and purification procedures that remove protein, the allergenic component of corn. Therefore, carbohydrate source is considered hypoallergenic7.

      Vitamins and Minerals

      PurAmino Toddler has vitamins and minerals to help support growth and development.

      Calcium and Phosphorus

      PurAmino Toddler has calcium and phosphorus for growing toddlers. PurAmino Toddler has 94 mg calcium/100 Calories and 52 mg phosphorus/100 Calories.


      PurAmino Toddler has 18.2 mg iron/L Iron helps support growth and development

      Electrolytes—Sodium, Potassium, and Chloride

      The sodium, potassium, and chloride levels are 47 mg/100 Calories, 110 mg/100 Calories, and 86 mg/100 Calories, respectively.

  • Clinical Experience
    • Cow's milk protein allergy occurs in approximately 2%–3% of infants8. Many healthcare professionals use an extensively hydrolyzed protein formula for the dietary management of cow's milk protein allergy. However, up to 10% of infants with severe cow's milk or food protein allergies develop specific IgE against extensively hydrolyzed casein or whey protein and may require a special formula made of free amino acids. Several of the studies using amino acid–based formulas are summarized below.


      Elimination of milk and other foods from a child's diet as part of the management of milk protein allergy and/or multiple food protein allergies may impact growth and overall nutritional status9. Therefore, it is not surprising that the key criteria for assessing the safety and efficacy of a hypoallergenic formula are weight gain and height increases. In this regard, there are a number of clinical studies demonstrating that amino acid–based formulas can both improve compromised growth in infants and young children with severe cow's milk protein allergy and/or multiple food protein allergies and continue to support their growth when used for a short period or long term9-14.

      Safety and Efficacy

      There are several clinical trials demonstrating the safety and efficacy of reduced antigenic dietary products. However, adverse responses to these cow's milk substitutes may continue to persist in some highly allergic infants. Incidence allergic responses to hydrolyzed formulas, including extensively hydrolyzed formulas, has been reported over the past few years15,16.

      In contrast to the residual allergenicity of partial and extensively hydrolyzed formulas, formulas based on free amino acid solutions are designed to contain no intact proteins or peptides17,18. As a result, there is substantial clinical evidence demonstrating the efficacy of amino acid–based formulas in these situations.

      Skin Health and Digestive Health

      In the dietary management of cow's milk protein allergy, benefits in skin health as well as digestive health are often seen. Atopic dermatitis is common in infants with cow's milk allergy. It has been reported that about one third of infants with severe atopic dermatitis have clinical reactivity to food proteins, including cow's milk and soy proteins19. There have been several clinical studies evaluating the efficacy of amino acid-based formulas in improving skin health as a result of continued allergenicity to cow's milk formula and extensively hydrolyzed proteins9,12,17,20. The SCORAD (SCORing Atopic Dermatitis) has been shown to decrease as dietary management with an amino acid-based formula is continued12.

      Digestive issues are common in infants with an allergy to cow's milk protein or extensively hydrolyzed protein formulas. Multiple food protein allergies have been implicated as one of the causes of persistent child distress. It is well known that dietary antigens are capable of provoking gastroduodenal inflammations and hypermotility in hypersensitivity reactions. A number of clinical studies demonstrate the efficacy of amino acid-based formulas for improved GI health in infants and children allergic to cow's milk protein and extensively hydrolyzed protein formulas11,13,17,20-23.

      Multiple Food Allergies

      Studies suggest that many children who are allergic to cow's milk protein may develop an allergy to a large variety of other foods, such as eggs, wheat, peanuts, soy and even protein hydrolysates. This scenario is typically defined as “multiple intolerances” to dietary proteins in children and may affect 5%–8% of children during the first three years of life11,14,20,23. According to Latcham et al24, "recently there have been increasing reports of multiply-sensitized infants, often despite exclusive breastfeeding.” In the initial studies of Hill et al13, some patients with cow's milk allergy also had adverse reactions to soy milk or casein hydrolysates. Many were also intolerant to other foods (ie, multiple food proteins). A delay in the diagnosis and initiation of appropriate dietary management could sustain and/or worsen these multiple allergies. Clinical studies by Ammar et al11, Hill et al13 and Latcham et al24 add to the growing body of evidence demonstrating the potential benefits of using an amino acid-based formula for the dietary management of infants with multiple food allergies. PurAmino Toddler is a hypoallergenic formula for patients with severe cow's milk allergy and multiple food allergies.

      Malabsorption and Maldigestion

      Conditions resulting in maldigestion and malabsorption can be problematic for maintaining or achieving appropriate nutrient status and potentially have additional effects such as gastrointestinal issues, changes in stool patterns, and ultimately impact growth and development. Clinicians may often recommend use of an elemental formula to help promote absorption of essential nutrients. Indeed, studies in infants and children with chronic diarrhea suggest that use of an elemental formula may be beneficial. Antonson and colleagues examined the effects of an amino acid-based formula with MCT oil on 27 infants <12 months of age with chronic diarrhea, with improvements in growth and gastrointestinal issues reported25,26.

      Short Bowel Syndrome

      Elemental diets may also be considered for patients with short bowel syndrome. While some cases are congenital, short bowel syndrome is typically a result of intestinal resection, in which parts of the small and/or large intestine are removed due to disease or trauma27. Bowel resection reduces the absorptive surface area of the gut, which can lead to maldigestion and malabsorption. Thus, strategies for improving nutrient digestion and absorption are necessary to promote growth and development. Protein hydrolysate or amino acid-based formulas are often used in the dietary management of infants and children with short bowel syndrome27-29. In terms of the lipid requirements, it has been suggested that a mixture of both medium-chain and long-chain triglycerides is needed in patients with short bowel syndrome28,30. Due to the malabsorption that occurs, MCTs are particularly important as they are easily and quickly absorbed; however, long-chain triglycerides are still needed as they are key for stimulating trophic effects in the intestine as well as meeting essential fatty acid requirements27,30.

      Indeed, studies suggest amino acid-based formulas may be beneficial. Using a retrospective chart review of children with short bowel syndrome, Andorsky and colleagues noted that use of an amino-acid based formula was associated with a shorter duration of parenteral nutrition use36. Similarly, Bines and colleagues conducted a small study of infants and children with short bowel syndrome who had a feeding intolerance to hydrolyzed formulas, noting that feeding tolerance improved within 1 month and patients were weaned from parenteral nutrition within 15 months21.

      Eosinophilic Esophagitis

      In addition to the conditions described above, elemental formulas are also commonly used in patients with eosinophilic esophagitis. Dietary recommendations include food eliminations based on allergy testing or use of an amino acid-based elemental formula in infants and children32. Indeed, studies conducted by Liacouras et al33, Markowitz et al34, and Kelly et al35 suggest that elemental formulas improve gastrointestinal issues and esophageal histology in infants and children.

  • References
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      2. Birch EE, Hoffman DR, Uauy RD, et al. Visual acuity and the essentiality of docosahexaenoic acid and arachidonic acid in the diet of term infants. Pediatr Res. 1998;44:201–209.

      3. Birch EE, Garfield S, Hoffman DR, et al. A randomized controlled trial of early dietary supply of long–chain polyunsaturated fatty acids and mental development in term infants. Dev Med Child Neurol. 2000;42:174–181.

      4. Birch EE, Garfield S, Castañeda YS, et al. Visual acuity and cognitive outcomes at 4 years of age in a double–blind, randomized trial of long–chain polyunsaturated fatty acid–supplemented infant formula. Early Hum Dev. 2007;83:279–284.

      5. Data on File, Mead Johnson Nutritionals. May, 1998.

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      7. Richardson GG, Leary HL, Halsey JF. Allergenicity of corn–derived carbohydrate ingredients for use in infant formulas [abstract]. Presentation at American College of Allergists 5th International Food Allergy Symposium. October 15–18, 1984.

      8. Høst A, Koletzko B, Dreborg S, et al. Dietary products used in infants for treatment and prevention of food allergy. Joint statement of the European Society for Paediatric Allergology and Clinical Immunology (ESPACI) Committee on Hypoallergenic Formulas and the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) Committee on Nutrition. Arch Dis Child. 1999;81:80–84.

      9. Niggemann B, Schnabel D, Grüters A, et al. Influence of dietary intervention on serum growth factors in infants with atopic dermatitis and cow's milk allergy—a pilot study. Allergo J. 2002;11:48–53.

      10. Isolauri E, Sütas Y, Mäkinen–Kiljunen S, et al. Efficacy and safety of hydrolyzed cow milk and amino acid–derived formulas in infants with cow milk allergy. J Pediatr. 1995;127:550–557.

      11. Ammar F, de Boissieu D, Dupont C. Allergy to protein hydrolysates: concerning 30 cases. Arch Pediatr. 1999;6:837–843.

      12. Kanny G, Moneret–Vautrin DA, Flabbee J, et al. Value of a formula based on amino acids in the treatment of allergy to the proteins of cow's milk and the syndrome of multiple food allergies. Allergie et Immunologie. 2002;34:82–84.

      13. Hill DJ, Heine RG, Cameron DJ, et al. The natural history of intolerance to soy and extensively hydrolyzed formula in infants with multiple food protein intolerance. J Pediatr. 1999;135:118–121.

      14. Sicherer SH, Noone SA, Koerner CB, et al. Hypoallergenicity and efficacy of an amino acid–based formula in children with cow's milk and multiple food hypersensitivities. J Pediatr. 2001;138:688–693.

      15. Rance F, Brondeau V, Abbal M. Use of prick–tests in the screening of immediate allergy to protein: 16 cases. Allerg Immunol (Paris). 2002;34:71–76.

      16. Kaczmarski M, Wasilewska J, Lasota M. Hypersensitivity to hydrolyzed cow's milk protein formula in infants and young children with atopic eczema/dermatitis syndrome with cow's milk protein allergy. Rocz Akad Med Bialymst. 2005;50:274–278.

      17. Rigourd V, Magny JF, Ayachi A, et al. Neonatal allergy to extensively hydrolyzed cow's milk proteins. Rev Fr Allergol Immunol Clin. 2000;40:185–189.

      18. Sampson HA, James JM, Bernhisel–Broadbent J. Safety of an amino acid–derived infant formula in children allergic to cow milk. Pediatrics. 1992;90:463–465.

      19. Leung TF, Ma KC, Cheung LT, et al. A randomized, single–blind and crossover study of an amino acid–based milk formula in treating young children with atopic dermatitis. Pediatr Allergy Immunol. 2004;15:558–561.

      20. Hill DJ, Cameron DJ, Francis DE, et al. Challenge confirmation of late–onset reactions to extensively hydrolyzed formulas in infants with multiple food protein intolerance. J Allergy Clin Immunol. 1995;96:386–394.

      21. Bines J, Francis D, Hill D. Reducing parenteral requirement in children with short bowel syndrome: impact of an amino acid–based complete infant formula. J Pediatr Gastroenterol Nutr. 1998;26:123–128.

      22. Vanderhoof JA, Murray ND, Kaufman SS, et al. Intolerance to protein hydrolysate infant formulas: an underrecognized cause of gastrointestinal symptoms in infants. J Pediatr. 1997;131:741–744.

      23. Salvatore S, Vandenplas Y. Gastroesophageal reflux and cow milk allergy: is there a link? Pediatrics. 2002;110:972–984.

      24. Latcham F, Merino F, Lang A, et al. A consistent pattern of minor immunodeficiency and subtle enteropathy in children with multiple food allergy. J Pediatr. 2003;143:39–47.

      25. Antonson DL, Murray ND, Oliva-Hemker MM, et al. Nutritional management of infants with chronic diarrhea fed a free amino acid-based medical food. J Pediatr Gastrroenterol Nutr. 2002;35:443:A110.

      26. Saavedra JM, Mattis LE, Chao C, et al. Use of an amino acid (AA)-based formula for the management of chronic diarrhea in children. Pediatr Res. 2000;47:168A:987.

      27. Vanderhoof JA, Langnas AN. Short-bowel syndrome in children and adults. Gastroenterology. 1997;113:1767-1778.

      28. Abad-Sinden A, Sutphen J. Nutritional management of pediatric short bowel syndrome. Practical Gastroenterology. 2003;12:28-48.

      29. Wessel JJ, Kocoshis SA. Nutritional management of infants with short bowel syndrome. Semin Perinatol. 2007;31:104-111.

      30. Goulet O. Lipid requirements in infants with digestive diseases with references to short bowel syndrome. Eur J Med Res. 1997;2:79-83.

      31. Andorsky DJ, Lund DP, Lillehei CW, et al. Nutritional and other postoperative management of neonates with short bowel syndrome correlates with clinical outcomes. J Pediatr. 2001;139:27-33.

      32. Furuta GT, Liacouras CA, Collins MH, et al. Eosinophilic esophagitis in children and adults: a systematic review and consensus recommendations for diagnosis and treatment. Gastroenterology. 2007;133:1342-1363.

      33. Liacouras CA, Spergel JM, Ruchelli E, et al. Eosinophilic esophagitis: a 10-year experience in 381 children. Clin Gastroenterol Hepatol. 2005;3:1198-1206.

      34. Markowitz JE, Spergel JM, Ruchelli E, et al. Elemental diet is an effective treatment for eosinophilic esophagitis in children and adolescents. Am J Gastroenterol. 2003;98:777-782.

      35. Kelly KJ, Lazenby AJ, Rowe PC, et al. Eosinophilic esophagitis attributed to gastroesophageal reflux: improvement with an amino acid-based formula. Gastroenterology. 1995;109:1503-1512.

      36. Vandenplas Y, Brueton M, Dupont C, et al. Guidelines for the diagnosis and management of cow’s milk protein allergy in infants. Arch Dis child 2007;92:902-908.

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