• Enfamil Gentlease 20.9 oz Powder
  • Enfamil Gentlease 12.4 oz Powder
  • Enfamil Gentlease 8 oz RTU
  • Enfamil Gentlease 6 oz RTU
  • Enfamil Gentlease 2 oz RTU

Enfamil® Gentlease®

For fussiness, gas and crying

Milk-based infant formula that has partially broken down proteins for the first 12 months.

Last Updated: Tuesday, January 9, 2018

#1 Pediatrician recommended brand for gassy and fussy babies*
  • Description/Indication
    • Enfamil Gentlease is a 20 Cal/fl oz, milk-based infant formula designed to reduce fussiness, gas and crying1. It has an easy-to-digest milk protein blend patterned after breast milk (whey and casein in a 60:40 ratio)* that has been partially broken down. The formula is nutritionally balanced and has docosahexaenoic acid (DHA) and arachidonic acid (ARA), nutrients also found in breast milk that promote brain and eye development.

      Long-Term Usage:

      Enfamil Gentlease is designed to provide the sole source of nutrition for infants up to age 6 months and provide a major source of nutrition for the remainder of the first year.

      * Comparison to whey:casein ratio of typical mature breast milk (15 days to 6 months after birth) prior to hydrolysis.

  • Product Features
      • DHA at the clinically proven amount of 0.32% of total fatty acids, the same amount as the worldwide breast milk average2,†, and double the amount found in the leading competitor’s product:
        • Clinically proven to support mental and visual development
        • Clinically shown to improve long-term cognitive outcomes through 5 years of age3
        • Shown to improve respiratory health through the first 3 years of life when infants were fed through 12 months4,‡
      • Designed to reduce fussiness, gas and crying in 24 hours1
      • A special blend of easy-to-digest proteins, patterned after the blend of proteins found in breast milk*, that have been partially broken down
      • Has ~20% of lactose§ as a source of carbohydrates; infants with transient lactase deficiency generally can tolerate formulas with some lactose
      • No artificial flavors, sweeteners or colors
      • Kosher

      * Comparison to whey:casein ratio of typical mature breast milk (15 days to 6 months after birth) prior to hydrolysis. † Average amount of DHA in worldwide breast milk is 0.32% ± 0.22% (mean ± standard deviation of total fatty acids) based on an analysis of 65 studies of 2,474 women2. ‡ Studies compared infants fed Enfamil® that had DHA and ARA vs. discontinued Enfamil without DHA and ARA; studied before the addition of prebiotic ingredients. § Of a routine formula.

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

      (Normal Dilution) Per 100 Calories (5 fl oz) Per 100 Calories (5 fl oz) Per 100 Calories (5 fl oz) Per 100 Calories (5 fl oz) Per 100 mL Per 100 grams
      Powder 2 fl oz 6 fl oz 8 fl oz Powder (510 Cal)
      Protein, g 2.3 2.3 2.3 2.3 1.55 11.7
      Fat, g 5.3 5.3 5.3 5.3 3.6 27
      Linoleic acid, mg 800 860 800 860 580 4100
      Carbohydrate, g 10.8 10.8 10.8 10. 8 7.3 55
      Water, g 133 133 133 133 90 2.4
      (Normal Dilution) Per 100 Calories (5 fl oz) Per 100 Calories (5 fl oz) Per 100 Calories (5 fl oz) Per 100 Calories (5 fl oz) Per 100 mL Per 100 grams
      Vitamins/Other Nutrients Powder 2 fl oz 6 fl oz 8 fl oz Powder (510 Cal)
      Vitamin A, IU 300 300 300 300 200 1530
      Vitamin D, IU 60 60 60 60 41 310
      Vitamin E, IU 2 2 2 2 1.35 10.2
      Vitamin K, mcg 9 9 9 9 6.1 46
      Thiamin (Vitamin B1), mcg 80 80 80 80 54 410
      Riboflavin (Vitamin B2), mcg 140 140 140 140 95 710
      Vitamin B6, mcg 60 60 60 60 41 310
      Vitamin B12, mcg 0.3 0.3 0.3 0.3 0.2 1.53
      Niacin, mcg 1000 1000 1000 1000 680 5100
      Folic acid (Folacin), mcg 16 16 16 16 10.8 82
      Pantothenic acid, mcg 500 500 500 500 340 2600
      Biotin, mcg 3 3 3 3 2 15.3
      Vitamin C (Ascorbic acid), mg 12 12 12 12 8.1 61
      Choline, mg 24 24 24 24 16.2 122
      Inositol, mg 6 6 6 6 4.1 31
      (Normal Dilution) Per 100 Calories (5 fl oz) Per 100 Calories (5 fl oz) Per 100 Calories (5 fl oz) Per 100 Calories (5 fl oz) Per 100 mL Per 100 grams
      Minerals Powder 2 fl oz 6 fl oz 8 fl oz Powder (510 Cal)
      Calcium, mg 82 82 82 82 55 420
      Phosphorus, mg 46 46 46 46 31 230
      Magnesium, mg 8 8 8 8 5.4 41
      Iron, mg 1.8 1.8 1.8 1.8 1.22 9.2
      Zinc, mg 1 1 1 1 0.68 5.1
      Manganese, mcg 15 15 15 15 10.1 77
      Copper, mcg 75 75 75 75 51 380
      Iodine, mcg 15 15 15 15 10.1 77
      Selenium, mcg 2.8 2.8 2.8 2.8 1.89 14.3
      Sodium, mg 36 36 36 36 24 184
      Potassium, mg 108 108 108 108 73 550
      Chloride, mg 63 63 63 63 43 320
  • Nutrient Facts
    • Nutrient Density 20 Calories/fl oz
      Protein (% Calories) 9
      Whey:Casein Ratio 60:40
      Fat (% Calories) 48
      Carbohydrate (% Calories) 43
      Potential Renal Solute Load (mOsm/100 Calories)5 21
      Potential Renal Solute Load (mOsm/100 mL)5 14
      Osmolality (mOsm/kg water) 230 (Pwd) 220 (RTU)
      Osmolarity (mOsm/L) 210 (Pwd) 200 (RTU)
      Lactose-Free No
  • Product Forms
    • Enfamil Gentlease is available in powder and ready-to-use liquid.

      Item #: 8693Y4
      Description: Enfamil Gentlease Pwd
      Unit Size: 20.9 oz Can
      Cal./Unit:
      Prod. Yield / Unit (fl oz):
      Case: 4 Cans/Case
      Reimbursement Code: 00087-511978

    • Item #: 869353
      Description: Powder
      Unit Size: 12.4 oz can
      Cal./Unit: 1740
      Prod. Yield / Unit (fl oz): 90
      Case: 6 cans per case
      Reimbursement Code: 00087-510069

    • Item #: 146401
      Description: Enfamil Gentlease Nursette® 20 Cal RTU
      Unit Size: 2 fl oz bottle
      Cal./Unit: 40
      Prod. Yield / Unit (fl oz): 2
      Case: 48 bottles per case
      Reimbursement Code: 00087-146441

    • Item #: 153801
      Description: Enfamil Gentlease RTU
      Unit Size: 8 fl oz bottle
      Cal./Unit: 160
      Prod. Yield / Unit (fl oz): 8
      Case: 24 bottles per case
      Reimbursement Code: 00087-510341

    • Item #: 129501
      Description: RTU
      Unit Size: 6 fl oz bottle
      Cal./Unit: 120
      Prod. Yield / Unit (fl oz): 6
      Case: 24 bottles per case
      Reimbursement Code: 00087-510523

  • Composition
    • Ingredients: Powder: Corn syrup solids, partially hydrolyzed nonfat milk and whey protein concentrate solids (soy), vegetable oil (palm olein, soy, coconut and high oleic sunflower oils) and less than 2%: Mortierella alpina oil§, Crypthecodinium cohnii oil||, vitamin A palmitate, vitamin D3, vitamin E acetate, vitamin K1, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, vitamin B12, niacinamide, folic acid, calcium pantothenate, biotin, ascorbic acid, choline chloride, inositol, calcium carbonate, calcium phosphate, magnesium phosphate, ferrous sulfate, zinc sulfate, manganese sulfate, cupric sulfate, sodium selenite, sodium citrate, potassium chloride, potassium iodide, taurine, L-carnitine.

      Ingredients: Ready To Use (2 & 6 fl oz Nursette® bottles, 8 fl oz bottle): Water, corn syrup solids, partially hydrolyzed nonfat milk and whey protein concentrate solids (soy), vegetable oil (palm olein, soy, coconut and high oleic sunflower oils), rice starch and less than 1%: Mortierella alpina oil§, Crypthecodinium cohnii oil||, vitamin B12, vitamin D3, ascorbic acid, vitamin E acetate, niacinamide, calcium pantothenate, vitamin A palmitate, riboflavin, thiamin hydrochloride, vitamin B6 hydrochloride, choline chloride, inositol, folic acid, vitamin K1, biotin, diacetyl tartaric esters of mono- and diglycerides (datem), calcium carbonate, calcium phosphate, magnesium chloride, ferrous sulfate, zinc sulfate, sodium citrate, cupric sulfate, manganese sulfate, potassium iodide, sodium selenite, taurine, L-carnitine.

      § A source of arachidonic acid (ARA) || A source of docosahexaenoic acid (DHA)

  • Potential Allergens
    • Enfamil® Gentlease® contains milk and soy.

  • 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.

      POWDER

      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.

      Use the charts below for correct amounts of water and powder. Use scoop in tub or can to measure powder. Store DRY scoop in lid holder in tub or in can.

      Enfamil® Gentlease®

      To Make†† Water Powder Weight
      2 fl oz bottle 2 fl oz 1 unpacked level scoop 8.7 g
      4 fl oz bottle 4 fl oz 2 unpacked level scoops 17.4 g
      8 fl oz bottle 8 fl oz 4 unpacked level scoops 34.8 g

      †† Each scoop adds about 0.2 fl oz to the amount of prepared formula.

      SINGLE-SERVE POWDER PACKETS

      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. Pour entire contents of packet(s) into bottle.

      3. Cap bottle and SHAKE WELL.

      Use the charts below for correct amounts of water and powder.

      Enfamil PREMIUM® Infant

      To Make‡‡ Water Powder Weight
      4 fl oz bottle 4 fl oz 1 packet 17.4 g
      8 fl oz bottle 8 fl oz 2 packets 34.8 g

      ‡‡ Each packet adds about 0.4 fl oz to the amount of prepared formula.

      READY TO USE

      2 & 6 fl oz Nursette® Bottles

      1. Inspect each bottle for signs of damage.

      2. Wash hands thoroughly with soap and water before preparing bottle for feeding.

      3. SHAKE BOTTLE WELL and remove cap.

      4. Attach nipple unit (not included).

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

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

      8 & 32 fl oz Bottles

      1. Wash hands thoroughly with soap and water before preparing feeding bottles.

      2. SHAKE BOTTLE WELL, remove protective seal around cap, remove cap and foil seal.

      3. Pour into feeding bottle(s).

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

      Failure to follow these instructions could result in severe harm. Opened bottles and prepared formula can spoil quickly. Either feed immediately or cover and store in refrigerator at 35–40°F (2–4°C) for no longer than 48 hours. Do not use opened bottle and/or prepared formula if they are unrefrigerated for more than a total of 2 hours. Do not freeze prepared formula. After feeding begins, use prepared formula within 1 hour or discard.

  • Product Characteristics
    • Fat
      The fat content in Enfamil Gentlease is 48% of total calories. The fat blend consists of approximately:

      • 44% palm olein oil

      • 19.5% soy oil

      • 19.5% coconut oil

      • 14.5% high oleic sunflower oil

      • 2.5% single-cell oil blend rich in DHA (docosahexaenoic acid) and ARA (arachidonic acid)

      The levels of total fat and saturated, monounsaturated, and polyunsaturated fatty acids in Enfamil Gentlease are patterned after levels found in mature U.S. breast milk12,13. Human milk contains, on average, between 20% and 24% of the fatty acids as palmitic acid12. Using palm olein oil in the fat blend results in Enfamil Gentlease having palmitic acid levels similar to breast milk12. Linoleic acid provides about 17% of the total fatty acids in Enfamil Gentlease, which is within the range of means found in average, mature U.S. breast milk (14%—19%)12.

      DHA and ARA

      Enfamil Gentlease has DHA and ARA, two nutrients also found in breast milk, that are important building blocks for a baby's brain and eyes3-10. The level of DHA in Enfamil Gentlease is similar to that found in average worldwide breast milk12,14-16, §§, as well as levels specified by expert groups17-20.

      Enfamil Gentlease DHA Level within Recommended Levels

      §§ Average level of DHA in worldwide breast milk is 0.32% ± 0.22% (mean ± standard deviation of total fatty acids) based on an analysis of 65 studies of 2,474 women.

      Protein
      The protein content in Enfamil Gentlease is approximately 9% of total calories. Nonfat milk and whey protein concentrate are the sources of protein. The proteins in Enfamil Gentlease are partially hydrolyzed or broken down. The hydrolysate conforms to specific physical, chemical, and microbiological standards, which are specified by Mead Johnson and designed to ensure safety and delivery of labeled nutrients in the products. Mead Johnson amino acid profile analyses confirm the amino acid composition is essentially the same for both Enfamil Gentlease and Enfamil LIPIL.

      Carbohydrate
      The carbohydrate content in Enfamil Gentlease is approximately 43% of total calories. The carbohydrate in Gentlease is ~80% corn syrup solids and ~20% lactose. Corn syrup solids are readily digested and well tolerated by infants whose ability to digest other carbohydrates, such as lactose or sucrose, is impaired. The production of corn syrup solids includes filtration and purification procedures that remove protein, the allergenic component of corn; therefore, corn syrup solids are considered hypoallergenic21. Enfamil Gentlease is not recommended for patients with galactosemia.

      Vitamins and Minerals
      Enfamil Gentlease meets U.S. Food and Drug Administration requirements for vitamins and minerals as mandated by the U.S. Infant Formula Act and the associated Code of Federal Regulations 21 C.F.R. part 10722.

      Calcium and Phosphorus
      Enfamil Gentlease provides 82 mg of calcium/100 Calories, 46 mg of phosphorus/100 Calories, and has a calcium:phosphorus ratio of about 1.78:1.

      Iron
      Enfamil Gentlease provides 12.2 mg iron/L, or 1.8 mg iron/100 Calories. The AAP states that infants who are not breastfed should receive iron-fortified formula23.

      Electrolytes—Sodium, Potassium, and Chloride
      The electrolyte levels in Enfamil Gentlease are within the ranges specified by U.S. Food and Drug Administration regulations as mandated by the Infant Formula Act22. The sodium, potassium, and chloride levels are 36 mg/100 Calories, 108 mg/100 Calories, and 63 mg/100 Calories, respectively.

  • Clinical Experience
    • Safety and Tolerance

      The sources of DHA and ARA in Enfamil Gentlease are well tolerated and safe. In clinical studies comparing infants fed formulas including DHA and ARA with infants fed formulas without DHA and ARA, there were no clinically significant differences in tolerance, and the addition of DHA and ARA had no effect on the incidence of adverse events24-26. The sources of DHA and ARA in Enfamil Gentlease are Generally Recognized as Safe (GRAS) for use in infant formulas by the U.S. Food and Drug Administration27,28.

      Clinical Response to 2 Commonly Used Switch Formulas Occurs Within 1 Day

      This study demonstrated a partially hydrolyzed CMP, low lactose formula improved formula tolerance as well as a soy-based, lactose-free formula in an infant population parent-identified as very or extremely fussy using a baseline evaluation at enrollment.

      Carol Lynn Berseth, MD, William H. Johnston, MD,
      Suzanne I. Stolz, Cheryl L. Harris, MS, and
      Susan Hazels Mitmesser, PhD

  • References
    • 1. Berseth CL, Johnston WH, Stolz SI, et al. Clinical response to 2 commonly used switch formulas occurs within 1 day. Clin Pediatr (Phila). 2009;48:58-65.

      2. Brenna JT, Varamini B, Jensen RG, et al. Docosahexaenoic and arachidonic acid concentrations in human breast milk worldwide. Am J Clin Nutr. 2007;85:1457-1464.

      3. Colombo J, Carlson SE, Cheatham CL, et al. Long-term effects of LCPUFA supplementation on childhood cognitive outcomes. Am J Clin Nutr. 2013;98:403-412.

      4. Birch EE, Khoury JC, Berseth CL, et al. The impact of early nutrition on incidence of allergic manifestations and common respiratory illnesses in children. J Pediatr. 2010;156:902-906.

      5. Fomon SJ, Ziegler EE. Renal solute load and potential renal solute load in infancy. J Pediatr. 1999;134:11-14.

      6. Hoffman DR, Birch EE, Castañeda YS, et al. Maturation of visual and mental function in 18-month old infants receiving dietary long-chain polyunsaturated fatty acids (LCPUFAs) [abstract]. FASB J. 2003;17:A727-A728. Abstract 445.1.

      7. Hoffman DR, Birch EE, Castañeda YS, et al. Visual function in breast-fed term infants weaned to formula with or without long-chain polyunsaturates at 4 to 6 months: a randomized clinical trial. J Pediatr. 2003;142:669-677.

      8. Hoffman DR, Birch EE, Birch DG, et al. Impact of early dietary intake and blood lipid composition of long-chain polyunsaturated fatty acids on later visual development. J Pediatr Gastroenterol Nutr. 2000;31:540-553.

      9. Birch EE, Castañeda YS, Wheaton DH, et al. Visual maturation of term infants fed long-chain polyunsaturated fatty acid-supplemented or control formula for 12 mo. Am J Clin Nutr. 2005;81:871-879.

      10. Morale SE, Hoffman DR, Castañeda YS, et al. Duration of long-chain polyunsaturated fatty acids availability in the diet and visual acuity. Early Hum Dev. 2005;81:197-203.

      11. Fomon SJ, Ziegler EE. Renal solute load and potential renal solute load in infancy. J Pediatr. 1999;134:11-14.

      12. Innis SM. Human milk and formula fatty acids. J Pediatr. 1992;120(suppl): S56-S61.

      13. Data on file, Mead Johnson Nutritionals, October 2005.

      14. Koletzko B, Thiel I, Abiodun PO. The fatty acid composition of human milk in Europe and Africa. J Pediatr. 1992;120(suppl):S62-S70.

      15. Data on file, Mead Johnson Nutritionals, September 2002.

      16. Jensen RG. Lipids in human milk. Lipids. 1999;34:1243-1271.

      17. The British Nutrition Foundation. Recommendations for Intakes of unsaturated fatty acids. In: Unsaturated Fatty Acids: Nutritional and Physiological Significance. London: Chapman & Hall; 1992:152-163.

      18. FAO/WHO Joint Expert Consultation. Lipids in early development. In: Fats and oils in human nutrition. Report of a joint expert consultation. Food and Agriculture Organization of the United States and the World Health Organization. FAO Food and Nutr Pap. 1994;57:49-55.

      19. Simopoulos AP, Leaf A, Salem N Jr. Workshop on the essentiality of and recommended dietary intakes for omega-6 and omega-3 fatty acids. J Am Coll Nutr. 1999;18:487-489.

      20. Koletzko B, Agostoni C, Carlson SE, et al. Long chain polyunsaturated fatty acids (LC-PUFA) and perinatal development. Acta Paediatr. 2001;90:460-464.

      21. Richardson GG, Leary L, 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.

      22. Nutrient Requirements for Infant Formulas. Code of Federal Regulations 21, C.F.R. 107.100. April 1, 2006.

      23. American Academy of Pediatrics, Committee on Nutrition. Iron fortification of infant formulas. Pediatrics. 1999;104:119-123.

      24. Carlson SE, Mehra S, Kagey WJ, et al. Growth and development of term infants fed formulas with docosahexaenoic acid (DHA) from algal oil or fish oil and arachidonic acid (ARA) from fungal oil [abstract]. Pediatr Res. 1999;45:278A. Abstract 1639.

      25. Clandinin MT, Van Aerde JE, Merkel KL, et al. Growth and development of preterm infants fed infant formulas containing docosahexaenoic acid and arachidonic acid. J Pediatr. 2005;146:461-468.

      26. Wheaton DH, Castañeda YS, Hoffman DR, et al. Biosafety of docosahexaenoic acid (DHA)/arachidonic acid (ARA) enriched infant formula fed for 9 months [abstract]. J Am Coll Nutr. 2003;22:469. Abstract 56.

      27. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition web site. Agency response letter GRAS Notice No. GRN 000041. Available at: http://www.cfsan.fda.gov/~rdb/opa-g041.html. Accessed April 19, 2007.

      28. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition web site. Agency response letter GRAS Notice No. GRN 000080. Available at: http://www.cfsan.fda.gov/~rdb/opa-g080.html. Accessed April 19, 2007.

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