• Enfamil® Gentlease®
  • Enfamil® Gentlease® - 32 fl oz
  • Enfamil® Gentlease® - 12.4 oz
  • Enfamil® Gentlease® - Non GMO 20.4
  • Enfamil® Gentlease® - 8 fl oz
  • Enfamil® Gentlease® Single-Serve Powder Packet

Enfamil® Gentlease®

For fussiness, gas and crying

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

Last Updated: Wednesday, September 30, 2015

#1 Pediatrician recommended brand for gassy and fussy babies*
  • Indication
    • Enfamil Gentlease infant formula is 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.

  • Product Features
      • A Neuro Complete blend of nutrients that are also found in breast milk
      • Has a DHA and ARA blend shown† to foster a child’s learning ability up to age 52
      • 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 lactose deficiency generally can tolerate formulas with some lactose
      • Has our blend of DHA and ARA, nutrients also found in breast milk, that promotes brain and eye development3-10
      • DHA level similar to worldwide breast milk averages
      • Has choline, a brain nutrient found in breast milk
      • Pediatricians recommend Gentlease 2 to 1 over Similac® Sensitive§.

      DHA and ARA Fatty Acid Nutrients||

      • DHA – 17 mg
      • ARA – 34 mg

      * Comparison to whey:casein ratio of typical mature breast milk (15 days to 6 months after birth).† Shown in Enfamil® Infant with DHA and ARA. 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. § Of pediatricians who recommend a specific brand of infant formula. || Per 100 Calories.

  • Nutrients
    • (Normal Dilution) Per 100 Calories (5 fl oz) Per 100 grams Powder (510 Cal)
      Protein, g 2.3 11.7
      Fat, g 5.3 27
      Linoleic acid, mg 800 (Pwd, 6 fl oz)
      860 (2, 8 & 32 fl oz)
      4100
      Carbohydrate, g 10.8 55
      Water, g 133 2.4
      (Normal Dilution) Per 100 Calories (5 fl oz) Per 100 grams Powder (510 Cal)
      Vitamins/Other Nutrients
      Vitamin A, IU 300 1530
      Vitamin D, IU 60 310
      Vitamin E, IU 2 10.2
      Vitamin K, mcg 9 46
      Thiamin (Vitamin B1), mcg 80 410
      Riboflavin (Vitamin B2), mcg 140 710
      Vitamin B6, mcg 60 310
      Vitamin B12, mcg 0.3 1.53
      Niacin, mcg 1000 5100
      Folic acid (Folacin), mcg 16 82
      Pantothenic acid, mcg 500 2600
      Biotin, mcg 3 15.3
      Vitamin C (Ascorbic acid), mg 12 61
      Choline, mg 24 122
      Inositol, mg 6 31
      (Normal Dilution) Per 100 Calories (5 fl oz) Per 100 grams Powder (510 Cal)
      Minerals
      Calcium, mg 82 420
      Phosphorus, mg 46 230
      Magnesium, mg 8 41
      Iron, mg 1.8 9.2
      Zinc, mg 1 5.1
      Manganese, mcg 15 77
      Copper, mcg 75 380
      Iodine, mcg 15 77
      Selenium, mcg 2.8 14.3
      Sodium, mg 36 184
      Potassium, mg 108 550
      Chloride, mg 63 320

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

  • Nutrient Facts
    • Nutrient Density 20 Calories/fl oz
      Protein (% Calories) 9
      Fat (% Calories) 48
      Carbohydrate (% Calories) 43.5
      Potential Renal Solute Load (mOsm/100 Calories)11 21
      Potential Renal Solute Load (mOsm/100 mL)11 14
      Osmolality (mOsm/kg water) 230 (Pwd) 220 (Liq)
      Osmolarity (mOsm/L) 210 (Pwd) 200 (Liq)
      Lactose-Free No
      Galactose-Free No
  • Product Forms
    • Enfamil® Gentlease® is available in powder and ready-to-use liquid.

    • 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 #: 8693C2
      Description: Powder
      Unit Size: 21.5 oz tub
      Cal./Unit: 3220
      Prod. Yield / Unit (fl oz): 161
      Case: 4 tubs per case
      Reimbursement Code: 00087-869376

    • Item #: 8693C1
      Description: Powder
      Unit Size: 32.2 oz box
      Cal./Unit: 4820
      Prod. Yield / Unit (fl oz): 241
      Case: 4 boxes per case
      Reimbursement Code: 00087-869377

    • Item #: 146401
      Description: 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: 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

    • Item #: 146501
      Description: RTU
      Unit Size: 32 fl oz can
      Cal./Unit: 640
      Prod. Yield / Unit (fl oz): 32
      Case: 6 cans per case
      Reimbursement Code: 00087-146541

    • Item #: 869369
      Description: Single-Serve Powder Packets
      Unit Size: 14 (17.4g) stick pks/carton
      Cal./Unit: 1260
      Prod. Yield / Unit (fl oz): 63
      Case: 4 units per case
      Reimbursement Code: 00087-510267

      HCPCS Code

  • 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 and L-carnitine.

      Ingredients: Ready To Use (32 fl oz can): 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**, choline chloride, inositol, vitamin B12, vitamin D3, ascorbic acid, vitamin E acetate, niacinamide, calcium pantothenate, vitamin A palmitate, riboflavin, thiamin hydrochloride, vitamin B6 hydrochloride, folic acid, vitamin K1, biotin, diacetyl tartaric esters of mono- and diglycerides (datem), calcium carbonate, calcium phosphate, magnesium chloride, ferrous sulfate, zinc sulfate, cupric sulfate, sodium citrate, manganese sulfate, potassium iodide, sodium selenite, taurine, L-carnitine.

      Ingredients: Ready To Use (6 fl oz Nursette® bottle, 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 these instructions. 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 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.

      Powder

      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 following chart for correct amounts of water and powder. Use scoop in can to measure powder. Store DRY scoop in its original can.

      To Make†† Water Powder Weight
      2 fl oz 2 fl oz 1 unpacked level scoop 8.7 g
      4 fl oz 4 fl oz 2 unpacked level scoops 17.4 g
      6 fl oz 6 fl oz 3 unpacked level scoops 26.1 g
      8 fl oz 8 fl oz 4 unpacked level scoops 34.8 g
      1 quart 28.5 fl oz 1 level household measuring cup plus 2 level tablespoons of unpacked powder 125 g

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

      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 the 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 within 1 hour or discard.

      Powder Storage (tubs and pouches)

      Store powder at room temperature; avoid extreme temperatures. Refill pouches can be used with reusable Enfamil Gentlease tubs, sold separately. After opening, keep pouch or tub lid tightly closed, store in a dry area and use contents within 1 month. Use with Enfamil Gentlease formula only.

      Keep powder fresh and prevent bacterial growth by assuring tub is clean and completely dry. Completely empty tub and wipe clean with a clean, dry cloth before refilling.

      If you choose to empty the pouch into the tub, you must retain the batch code and "use by" date sticker from the pouch.

      Powder Storage (cans)

      Store cans at room temperature. After opening the can, keep it tightly covered, store in a dry area and use the contents within 1 month. Do not freeze powder and avoid excessive heat. Use by date on the bottom of the can.

      Single-Serve Powder Packets

      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 following chart for correct amounts of water and powder.

      To Make‡‡ Water Powder
      4 fl oz bottle 4 fl oz 1 packet
      8 fl oz bottle 8 fl oz 2 packets

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

      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 the 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 within 1 hour or discard.

      Single-Serve Powder Packets Storage

      Store unopened packets at room temperature. Do not freeze powder, and avoid excessive heat.

      CAUTION Use product by date on container. Nutritional powders are not sterile.

      Ready To Use

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

      2. Clean can lid, SHAKE CAN WELL and open; or SHAKE BOTTLE WELL and remove cap and foil seal.

      3. Pour into feeding bottle(s).

      Failure to follow these instructions could result in severe harm. Opened cans/bottles and prepared bottles 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 can/bottle and/or prepared bottle if they are unrefrigerated for more than a total of 2 hours. Do not freeze prepared bottle. After feeding begins, use within 1 hour or discard.

      Ready To Use Storage

      Store unopened cans/bottles at room temperature. Avoid excessive heat. Do not freeze. Use by date on top of can or on bottle.

      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).

      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 the 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. After feeding begins, use within 1 hour or discard.

      Nursette Bottle Storage Store unopened bottles at room temperature. Avoid excessive heat and prolonged exposure to light. Do not freeze. Use by date on carton and bottle label.

      CAUTION Use product by date on container. Nutritional powders are not sterile.

      WARNING: Do not use a microwave oven to prepare or warm formula. Serious burns may result. Product information can also be found at MeadJohnson.com/pediatrics

  • 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. 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.

      3. 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.

      4. 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.

      5. Birch EE, Hoffman DR, Castañeda YS, et al. A randomized controlled trial of long-chain polyunsaturated fatty acid supplementation of formula in term infants after weaning at 6 wk of age. Am J Clin Nutr. 2002;75:570-580.

      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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