Nutramigen® LIPIL®

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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.
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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.
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