Nutramigen® LIPIL® Hypoallergenic Protein Hydrolysate Formula Description Nutramigen® LIPIL® is a hypoallergenic formula for infants who are sensitive to the intact protein found in milk-based and soy-based formulas. Nutramigen LIPIL contains extensively hydrolyzed protein proven effective for colic and other symptoms due to cow's milk protein allergy. The formula includes docosahexaenoic acid (DHA) and arachidonic acid (ARA), nutrients also found in breast milk, that promote brain and eye development. Product Features Hypoallergenic, lactose-free, and sucrose-free Clinically proven to resolve colic symptoms due to cow's milk protein allergy in 48 hours1,2* Proven effective in the dietary management of infants with allergic manifestations, including GI, skin, and respiratory symptoms Includes LIPIL, our blend of DHA and ARA, nutrients also found in breast milk, that promote brain and eye development3-10 Fatty acid profile patterned after breast milk11,12† Increased level of choline to be closer to the level found in breast milk.‡ Choline is an essential nutrient found in breast milk that, like DHA, is important for baby's brain development.13,14 * Studied before the addition of LIPIL, our blend of DHA and ARA. †Comparison based on fatty acid profile of typical mature U.S. breastmilk. ‡As calculated from the mean choline content of human milk determined by the Institute of Medicine. Indications Nutramigen LIPIL is an iron-fortified, lactose-free, sucrose-free, hypoallergenic infant formula for term infants who are sensitive to the intact proteins in cow's milk and soy formulas, as well as other foods. Such infants may have colic, rhinitis, wheezing, vomiting, diarrhea, bloody stools, mucus in stools, rash, or eczema. Nutramigen LIPIL is also appropriate for infants with galactosemia. Breast milk is the standard for infant nutrition and the American Academy of Pediatrics (AAP) recommends breastfeeding for most infants.15 According to the AAP, iron-fortified infant formula should be used if breastfeeding is not chosen, is discontinued during the first year, or if a supplement to breast milk is desired.16 Cow's milk is not recommended for infants before their first birthday. Long-Term Usage Nutramigen LIPIL is designed to provide a sole source of nutrition for infants up to age 6 months, and provide a major source of nutrition through 12 months of age. Normally, in feeding infants, gradual introduction of solid foods after 4—6 months of age is an important developmental as well as nutritional step. In cases of severe and multiple food allergies or intolerances, Nutramigen LIPIL is sometimes continued as a milk substitute in the diet of children. This and similar supplemental use of Nutramigen LIPIL in the diet beyond 12 months of age may make a significant contribution to maintenance of good nutrition in such patients. When Nutramigen LIPIL is used as a milk substitute, the total calcium content of the diet should be assessed. Although detrimental effects of prolonged use of Nutramigen LIPIL as the sole source of diet beyond 6 months of age have not been reported, there is no basis on which to recommend such a practice. Extended use of Nutramigen LIPIL (or other infant formulas) as a sole source of diet is most appropriately monitored by physicians and nutritionists on a case-by-case basis, with attention to developmental as well as nutritional implications of such a dietary regimen. Nutrients§ Normal Dilution Per 100 Calories (5 fl oz) Per 100 grams Powder Protein, g 2.8 13.9 Fat, g 5.3 26 Linoleic acid, mg 860 4300 Linolenic acid, mg 85 420 DHA, mg 17 84 ARA, mg 34 169 Carbohydrate, g 10.3 51 Water, g 133 3 Vitamins⁄Other Nutrients Vitamin A, IU 300 1490 Vitamin D, IU 50 250 Vitamin E, IU 2 9.9 Vitamin K, mcg 8 40 Thiamin (Vitamin B1), mcg 80 400 Riboflavin (Vitamin B2), mcg 90 450 Vitamin B6, mcg 60 300 Vitamin B12, mcg 0.3 1.49 Niacin, mcg 1000 5000 Folic acid (Folacin), mcg 16 79 Pantothenic acid, mcg 500 2500 Biotin, mcg 3 14.9 Vitamin C (Ascorbic acid), mg 12 60 Choline, mg 24 119 Inositol, mg 17 84 Carnitine, mg 2 9.9 Taurine, mg 6 30 Minerals Calcium, mg 94 470 Phosphorus, mg 52 260 Magnesium, mg 11 55 Iron, mg 1.8 8.9 Zinc, mg 1 5 Manganese, mcg 25 124 Copper, mcg 75 370 Iodine, mcg 15 74 Selenium, mcg 2.8 13.9 Sodium, mg 47 230 Potassium, mg 110 550 Chloride, mg 86 430 Molybdenum, mcg NA NA Chromium, mcg NA NA § 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) 11 Fat (% Calories) 48 Carbohydrate (% Calories) 41 Potential Renal Solute Load (mOsm⁄100 Calories)17 25 Potential Renal Solute Load (mOsm⁄100 mL)17 16.8 Osmolality (mOsm⁄kg water) 320 (Liq) 300 (Pwd) Osmolarity (mOsm⁄L) 290 (Liq) 270 (Pwd) Gluten-Free Yes Lactose-Free Yes Galactose-Free Yes Product Characteristics Fat The fat content in Nutramigen® LIPIL® 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 docosahexaenoic acid (DHA) and arachidonic acid (ARA) The levels of total fat and saturated, monounsaturated, and polyunsaturated fatty acids in Nutramigen LIPIL are patterned after levels found in mature U.S. breast milk.11,12 Human milk contains, on average, between 20% and 24% of the fatty acids as palmitic acid.11 Using palm olein oil in the fat blend results in Nutramigen LIPIL having palmitic acid levels similar to breast milk.11 Linoleic acid provides about 17% of the total fatty acids in Nutramigen LIPIL, which is within the range of means found in average, mature U.S. breast milk (14%—19%).11 DHA and ARA Nutramigen LIPIL includes DHA and ARA, two nutrients also found in breast milk that are important building blocks for a baby's brain and eyes.3-10 The level of DHA in Nutramigen LIPIL is similar to that found in average worldwide breast milk11,18-20|| as well as levels specified by expert groups.21-24 Middle of worldwide breast milk averages (25th-75th percentile range of 0.20% to 0.40% of total fatty acids), assuming about 50% of calories from fat. || Protein Protein provides 11% of total calories in Nutramigen LIPIL. The hypoallergenic protein source is extensively hydrolyzed casein that is supplemented with three amino acids—L-cystine, Ltyrosine, and L-tryptophan—to provide an appropriate balance of amino acids to the infant. The protein source provides a high percentage of free amino acids with the remainder as small peptides. The protein efficiency ratio (PER) for Nutramigen LIPIL is greater than the PER for casein.25 Thus, the protein in Nutramigen LIPIL is of very high quality. Every batch of protein hydrolysate used in Nutramigen LIPIL is tested for antigenicity using a procedure that detects the ability of a peptide to bind to a casein-specific antibody. The hydrolysates used in Nutramigen LIPIL result in an approximately 1 million-fold reduction in antigenicity compared with unmodified casein. Carbohydrate Carbohydrate provides 41% of total calories in Nutramigen LIPIL and the product is both lactose-free and sucrose-free. The carbohydrate blend in the powder is 86% corn syrup solids and 14% modified corn starch. The blend in the liquids is 75% corn syrup solids and 25% modified corn starch. The carbohydrates in Nutramigen LIPIL are readily digested and well tolerated by infants whose ability to digest other carbohydrates, such as lactose and sucrose, is impaired.26 The production of corn syrup solids and modified corn starch includes filtration and purification procedures that remove protein, the allergenic component of corn; therefore, these carbohydrate sources are considered hypoallergenic.27 Vitamins and Minerals Nutramigen LIPIL 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 107.28 Calcium and Phosphorus Nutramigen LIPIL contains 94 mg calcium⁄100 calories and 52 mg phosphorus⁄100 Calories. The calcium:phosphorus ratio is about 1.8:1, which is in the range specified by the Infant Formula Act.28 Iron Nutramigen LIPIL provides 12.2 mg iron/L. The AAP states that infants who are not breastfed should receive iron-fortified formula.16 Electrolytes—Sodium, Potassium, and Chloride The electrolyte levels in Nutramigen LIPIL are within the ranges specified by U.S. Food and Drug Administration regulations as mandated by the Infant Formula Act.28 The sodium, potassium, and chloride levels are 47 mg⁄100 Calories, 110 mg⁄100 Calories, and 86 mg⁄100 Calories, respectively. Clinical Experience Nutramigen was introduced in 1942 and numerous clinical experiences with the formula have been recorded since that time. Several of these experiences are summarized below.¶ Efficacy Studies Serologic response studies in healthy infants and children have shown that feeding Nutramigen results in lower immunology responses to proteins derived from cow's milk and soy.29,30 Many well-controlled studies have also shown that use of Nutramigen is associated with lower prevalence of cow's milk protein allergy symptoms in infants at high risk for allergy.31-34 Numerous clinical research studies also promote the use of Nutramigen in children with symptoms of allergy. Both double-blind placebo-controlled and single-blind studies provide evidence that most infants and children with cow's milk hypersensitivity are able to tolerate Nutramigen without adverse reactions.35-37 Serologic and dermatologic studies have also shown that extensively hydrolyzed formulas such as Nutramigen elicit much less reactivity in children with documented cow's milk allergy than cow's milk formulas.38,39 Furthermore, multiple studies have demonstrated that children with colic1,2,40,41 and enterocolitis42-44 caused by allergy to cow's milk or soy protein respond to Nutramigen feeding with improvement or resolution of symptoms. Although rare, allergic reactions to extensively hydrolyzed casein formulas have been reported.45-47 ¶Studied before the addition of LIPIL, our blend of DHA and ARA. Growth Studies conducted in healthy infants demonstrate that Nutramigen® promotes growth. In a 112-day growth study, 22 healthy male and female infants fed Nutramigen grew similar to historical control infants fed milk-based formula.48 Metabolic balance studies were also conducted in male infants (mean age 7.7 months, n=6) who were recovering from malnutrition. The diet promoted adequate catch-up weight gain and maintained satisfactory serum albumin concentrations. Nitrogen absorption and retention were excellent. Fat and energy balances and stool characteristics were all within the expected normal ranges.49 Safety and Tolerance Because of the special characteristics of Nutramigen, it does not taste like cow's milk and soybased formulas; however, most infants quickly adjust to the taste. A study evaluated infants' responses to Nutramigen as a novel food at 1-2 months of age or 7-8 months of age. Infants <2 months of age showed a slight reduction in intake of Nutramigen compared with their regular formula but continued to drink substantial and satiating amounts of Nutramigen. Older infants rejected the Nutramigen when it was offered. The investigators stated that acceptance of Nutramigen can be achieved in older infants, although not usually on the first presentation.50 The sources of DHA and ARA in Nutramigen LIPIL® are well tolerated. In clinical studies comparing infants fed formulas including LIPIL with infants fed formulas without LIPIL, there were no Clinically significant differences in tolerance and the addition of LIPIL had no effect on the incidence of adverse events.51-53 The sources of DHA and ARA in Nutramigen LIPIL are Generally Recognized as Safe (GRAS) for use in infant formulas by the U.S. Food and Drug Administration.54,55 Composition Ingredients: Powder: Corn syrup solids (46%), vegetable oil (palm olein, soy, coconut, and high oleic sunflower oils) (25%), casein hydrolysate (from milk)# (17%), modified corn starch (7%), and less than 2%: Mortierella alpina oil,** Crypthecodinium cohnii oil,†† acetylated monoglycerides, 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 citrate, calcium hydroxide, calcium phosphate, magnesium oxide, ferrous sulfate, zinc sulfate, manganese sulfate, cupric sulfate, sodium iodide, sodium selenite, sodium citrate, potassium citrate, potassium chloride, L-cystine, L-tyrosine, L-tryptophan, taurine, L-carnitine. Ingredients: Concentrated Liquid: Water (75%), corn syrup solids (10%), vegetable oil (palm olein, soy, coconut, and high oleic sunflower oils) (7%), casein hydrolysate (from milk)# (4%), modified corn starch (3%), and less than 1%: Mortierella alpina oil,** Crypthecodinium cohnii oil,†† acetylated monoglycerides, carrageenan, vitamin A palmitate, vitamin D3, vitamin E acetate, vitamin K1, thiamin hydochloride, riboflavin, vitamin B6 hydrochloride, vitamin B12, niacinamide, folic acid, calcium pantothenate, biotin, ascorbic acid, choline chloride, inositol, calcium carbonate, calcium phosphate, magnesium oxide, ferrous sulfate, zinc sulfate, manganese sulfate, cupric sulfate, sodium iodide, sodium selenite, sodium citrate, potassium citrate, potassium chloride, citric acid, taurine, L-cystine, L-tyrosine, L-tryptophan, L-carnitine. Ingredients: Ready To Use 32 fl oz and 6 fl oz: Water (87%), corn syrup solids (5%), vegetable oil (palm olein, soy, coconut, and high oleic sunflower oils) (3%), casein hydrolysate (from milk)# (2%), modified corn starch (2%), and less than 1%: Mortierella alpina oil,** Crypthecodinium cohnii oil,†† acetylated mono-glycerides, carrageenan, 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 oxide, ferrous sulfate, zinc sulfate, manganese sulfate, cupric sulfate, sodium iodide, sodium selenite, sodium citrate, potassium citrate, potassium chloride, citric acid, taurine, L-cystine, L-tyrosine, Ltryptophan, L-carnitine. Ingredients: Ready To Use 2 fl oz: Water (85%), corn syrup solids (6%), vegetable oil (palm olein, soy, coconut, and high oleic sunflower oils) (3%), casein hydrolysate (from milk)# (2%), modified corn starch (2%), and less than 1%: Mortierella alpina oil,** Crypthecodinium cohnii oil,†† acetylated mono-glycerides, carrageenan, 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 oxide, ferrous sulfate, zinc sulfate, manganese sulfate, cupric sulfate, sodium iodide, sodium selenite, sodium citrate, potassium citrate, potassium chloride, citric acid, taurine, L-cystine, L-tyrosine, L-tryptophan, L-carnitine. #Modified to be better tolerated in milk-allergic babies. **A source of arachidonic acid (ARA). ††A source of docosahexaenoic acid (DHA). Product Forms Nutramigen LIPIL is available in powder, concentrate, and ready-to-use liquid. Product Calories⁄ Yields Unit Unit, (fl oz) Item # Description Unit Size 049811 Concentrate 13 fl oz can 520 26 033821 1 lb (454 g) 2260 113 Powder Case NDC # 12 cans per case 0087049801 6 cans 0087per 033801 case Item # Description Unit Size Product Calories⁄ Yields Unit Unit, (fl oz) Case NDC # can 049911 RTU 32 fl oz can 640 32 6 cans 0087per 049901 case 143701 RTU 2 fl oz bottle 40 2 48 bottles 0087per 143741 case 429703 RTU 3 fl oz bottle 60 3 48 bottles 0087per 429743 case 026306 RTU 6 fl oz bottle 120 6 24 bottles 0087per 026324 case HCPCS Code Potential Allergens Nutramigen LIPIL contains milk and soy. Nutramigen LIPIL is hypoallergenic. Rarely, however, allergic reactions to extensively hydrolyzed casein formulas have been reported. Instructions for Preparation, Storage, and Use Select a specific form: Powder Formula Concentrated Liquid Formula Formula in Ready–to–Use Nursette® Bottles Ready–to–Use Formula in Cans Powder Formula Your baby's health depends on carefully following the instructions below. 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 your baby's doctor. Ask your baby's doctor which formula is appropriate for your baby. Ask your baby's doctor about the need to use cooled, boiled water for mixing and the need to boil clean utensils, bottles, and nipples in water before use. To Make an Individual Bottle from POWDER 1. 2. Wash hands thoroughly with soap and water before preparing formula. Pour the desired amount of water into the bottle. Mix powder formula with cool water (35–75°F); it should feel cool on your wrist. If you prefer, you may mix with warm water but only if you feed or refrigerate the formula immediately. Warm water is about 100°F or body temperature; it should feel neutral (neither warm nor cool) on your wrist. The amount necessary depends on the desired amount of formula. See chart below. Note: Never use hot tap water. To Make‡‡ Water Powder (use scoop inside can to measure powder) Weight 2 fl oz bottle 2 fl oz 1 packed level scoop 9g 4 fl oz bottle 4 fl oz 2 packed level scoops 18 g 6 fl oz bottle 6 fl oz 3 packed level scoops 27 g 8 fl oz bottle 8 fl oz 4 packed level scoops 36 g ‡‡ Each scoop adds about 0.2 fl oz to the amount of prepared formula. 3. 4. 5. 6. 7. 8. Add the amount of powder as stated in the chart above. Use the scoop that came in the can to measure powder. It is not necessary to wash the scoop. Store the DRY scoop in the can. Attach the nipple, ring, and disc or nipple cover (depending on type of bottle used). Shake for about 5 seconds. Failure to follow these instructions could result in severe harm. Once prepared, infant formula can spoil quickly. Either immediately feed or immediately cover and refrigerate 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, do not refrigerate feeding bottle. You must use within 1 hour or discard. Store cans at room temperature. After opening can, keep tightly covered, store in dry area, and use contents within 1 month. Do not freeze powder, and avoid excessive heat. Use by date on bottom of can. To Make Multiple Bottles from POWDER (Use these instructions only if feeding 32 fluid ounces within 24 hours.) 1. 2. Wash hands thoroughly with soap and water before preparing formula. Measure 29 fl oz of water into a bowl or large container. This will make 32 fl oz of infant formula. Mix powder formula with cool water (35–75°F); it should feel cool on your wrist. If you prefer, you may mix with warm water but only if you feed or refrigerate the formula immediately. Warm water is about 100°F or body temperature; it should feel neutral (neither warm nor cool) on your wrist. 3. Add 1 packed, level household measuring cup (1 cup size) or 129 g if weighing powder. 4. Beat the mixture with a clean fork until the powder is dissolved. 5. Pour prepared formula into bottles. 6. Attach the nipple, ring, and disc or nipple cover (depending on type of bottle used). 7. Shake for about 5 seconds before feeding. 8. Failure to follow these instructions could result in severe harm. Once prepared, infant formula can spoil quickly. Either immediately feed or immediately cover and refrigerate 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, do not refrigerate feeding bottle. You must use within 1 hour or discard. 9. Store cans at room temperature. After opening can, keep tightly covered, store in dry area, and use contents within 1 month. Do not freeze powder, and avoid excessive heat. 10. Use by date on bottom of can. Concentrated Liquid Formula Instructions for Preparation, Storage, and Use To Make an Individual Bottle from CONCENTRATED LIQUID FORMULA Your baby's health depends on carefully following the instructions below. Proper hygiene, preparation, dilution, use, and storage are important when preparing infant formula. Use as directed by your baby's doctor. Ask your baby's doctor about the need use cooled, boiled water for mixing and the need to boil clean utensils, bottles, and nipples in water before use. MUST ADD WATER. To Make an Individual Bottle from CONCENTRATED LIQUID FORMULA 1. 2. 3. 4. 5. 6. 7. 8. 9. Wash hands thoroughly with soap and water before preparing formula. Clean can lid, SHAKE CAN WELL, and open. Pour the concentrated liquid into the bottle. The amount necessary depends on the desired amount of formula. See chart below. To Make Water Concentrated Liquid Formula 4 fl oz 2 fl oz 2 fl oz 6 fl oz 3 fl oz 3 fl oz 8 fl oz 4 fl oz 4 fl oz Add 1 fl oz of water for every 1 fl oz of concentrated liquid. Mix concentrated liquid formula with cool water (35–75°F); it should feel cool on your wrist. If you prefer, you may mix with warm water but only if you feed or refrigerate the formula immediately. Warm water is about 100°F or body temperature; it should feel neutral (neither warm nor cool) on your wrist. Attach the nipple, ring, and disc or nipple cover (depending on type of bottle used). Shake well. Failure to follow these instructions could result in severe harm. Opened cans and prepared formula can spoil quickly. Either immediately feed or immediately cover and refrigerate at 35–40°F (2–4°C) for no longer than 48 hours. Do not use opened can and⁄or prepared formula if they are unrefrigerated for more than a total of 2 hours. Do not freeze prepared formula. After feeding begins, do not refrigerate feeding bottle. You must use within 1 hour or discard. Store unopened cans at room temperature. Avoid excessive heat. Do not freeze. Use by date on top of can. To Make Multiple Bottles from CONCENTRATED LIQUID FORMULA 1. 2. 3. 4. 5. 6. 7. 8. Wash hands thoroughly with soap and water before preparing formula. Clean can lid, SHAKE CAN WELL, and open. Measure 13 fl oz of water into a clean measuring cup. Mix concentrated liquid formula with cool water (35–75°F); it should feel cool on your wrist. If you prefer, you may mix with warm water but only if you feed or refrigerate the formula immediately. Warm water is about 100°F or body temperature; it should feel neutral (neither warm nor cool) on your wrist. Add 1 can of concentrated liquid (1 can=13 fl oz). This will make 26 fl oz of infant formula. Stir with a clean spoon. Pour the prepared formula into bottles. Attach the nipples, rings, and discs or nipple covers (depending on the type of bottle used). Failure to follow these instructions could result in severe harm. Opened cans and prepared formula can spoil quickly. Either immediately feed or immediately cover and refrigerate at 35–40°F (2–4°C) for no longer than 48 hours. Do not use opened can and⁄or prepared formula if they are unrefrigerated for more than a total of 2 hours. Do not freeze prepared formula. After feeding begins, do not refrigerate feeding bottle. You must use within 1 hour or discard. 9. 10. Store unopened cans at room temperature. Avoid excessive heat. Do not freeze. Use by date on top of can. Warming Instructions for Formula Prepared from Concentrated Liquid WARNING: Do not use the microwave to prepare or warm formula. Serious burns may result. If you want to warm a bottle that has been in the refrigerator, run warm tap water over the bottle or place the bottle in a pan of hot (not boiling) water. Shake bottle occasionally while warming. Warming time should be less than 15 minutes. Test the formula temperature before feeding; it should not feel warm or cold when dropped on your wrist — neutral is close to body temperature. However, most babies don't seem to mind whether their bottle is warmed or straight out of the refrigerator. Some may prefer a consistent temperature from one feeding to the next. In addition, once the bottle has been warmed, do not keep it for more than 1 hour. Then it should be discarded. Do not rewarm prepared formula (warming it more than once), even if the bottle has not been fed to the baby. Rewarming formula increases the possibility of bacterial growth in the formula as it cools off after heating. Bacteria can be present in bottles, on your hands, or introduced in other ways during formula preparation. Follow the safest procedures when feeding your baby. Formula in Ready-to-Use Nursette® Bottles Instructions for Preparation, Storage, and Use Your baby's health depends on carefully following the instructions below. Proper hygiene, preparation, use, and storage are important when preparing infant formula. Use as directed by your baby's doctor. Ask your baby's doctor about the need to boil a clean nipple in water before use. Inspect each bottle for signs of damage due to shipping. DO NOT ADD WATER. NURSETTE® BOTTLES OF READY-TO-USE FORMULA 1. 2. 3. 4. 5. 6. Wash hands thoroughly with soap and water before preparing bottle for feeding. SHAKE BOTTLE WELL and remove cap. Attach nipple unit (not included). Failure to follow these instructions could result in severe harm. Once opened, bottles of infant formula can spoil quickly. Either immediately feed or immediately replace cap and refrigerate at 35–40°F (2–4°C) for no longer than 48 hours. Do not use opened bottle if it is unrefrigerated for more than a total of 2 hours. Do not freeze. After feeding begins, do not refrigerate feeding bottle. You must use within 1 hour or discard. 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. Warming Instructions for Ready-To-Use Nursette Bottles of Formula WARNING: Do not use the microwave to prepare or warm formula. Serious burns may result. If you want to warm a Nursette bottle, run warm tap water over the unopened bottle or place it in a pan of hot (not boiling) water. Shake bottle occasionally while warming. Warming time should be less than 15 minutes. Test the formula temperature before feeding; it should not feel warm or cold when dropped on your wrist — neutral is close to body temperature. However, most babies don't seem to mind whether their bottle is warmed or straight out of the refrigerator. Some may prefer a consistent temperature from one feeding to the next. In addition, once the bottle has been warmed, do not keep it for more than 1 hour. Then it should be discarded. Do not rewarm prepared formula (warming it more than once), even if the bottle has not been fed to the baby. Rewarming formula increases the possibility of bacterial growth in the formula as it cools off after heating. Bacteria can be present in bottles, on your hands, or introduced in other ways during formula preparation. Follow the safest procedures when feeding your baby. Ready-to-Use Liquid Formula in Cans Instructions for Preparation, Storage, and Use Your baby's health depends on carefully following the instructions below. Proper hygiene, preparation, use, and storage are important when preparing infant formula. Use as directed by your baby's doctor. Ask your baby's doctor about the need to boil clean utensils, bottles, and nipples in water before use. DO NOT ADD WATER. 1. 2. 3. 4. 5. 6. 7. Wash hands thoroughly with soap and water before preparing feeding bottles. Clean can lid, SHAKE CAN WELL, and open. Pour the desired amount of formula into the bottles. DO NOT ADD WATER. Attach the nipples, rings, and discs or nipple covers. Failure to follow these instructions could result in severe harm. Opened cans and prepared bottles of formula can spoil quickly. Either immediately feed or immediately cover and refrigerate at 35–40°F (2–4°C) for no longer than 48 hours. Do not use opened can and⁄or prepared bottle if they are unrefrigerated for more than a total of 2 hours. Do not freeze prepared bottle. After feeding begins, do not refrigerate feeding bottle. You must use within 1 hour or discard. Store unopened cans at room temperature. Avoid excessive heat. Do not freeze. Use by date on top of can. Warming Instructions for Ready-to-Use Formula WARNING: Do not use the microwave to prepare or warm formula. Serious burns may result. If you want to warm a bottle that has been in the refrigerator, run warm tap water over the bottle or place the bottle in a pan of hot (not boiling) water. Shake bottle occasionally while warming. Warming time should be less than 15 minutes. Test the formula temperature before feeding; it should not feel warm or cold when dropped on your wrist — neutral is close to body temperature. However, most babies don't seem to mind whether their bottle is warmed or straight out of the refrigerator. Some may prefer a consistent temperature from one feeding to the next. In addition, once the bottle has been warmed, do not keep it for more than 1 hour. Then it should be discarded. Do not rewarm prepared formula (warming it more than once), even if the bottle has not been fed to the baby. Rewarming formula increases the possibility of bacterial growth in the formula as it cools off after heating. Bacteria can be present in bottles, on your hands, or introduced in other ways during formula preparation. Follow the safest procedures when feeding your baby. CAUTION This product is not recommended for routine use in very-low-birth-weight infants. Some of these infants may be at increased risk of developing gastrointestinal complications. CAUTION This information applies to products sold in the USA only. Formulations and mixing instructions for products sold outside the USA may vary. Refer to the information on the label of the product you are preparing.