English label for Enfamil™ Human Milk Fortifier Liquid High Protein

This unilingual English-labeled product is being temporarily imported from the United States to help address the ongoing shortage.

The French label is also available.

On this page

• Front of pack
• Side panel
• Instructions for use
• Product information (carton)
• Nutritional panel

Front of pack

CAUTION: Nutritionally Incomplete: To be used only under the supervision of a physician.

Do not administer directly- for mixing with breast milk only

Designed for formulary or centralized milk rooms only for customized volume fortification and batch mixing, using proper aseptic technique. ^{Footnote 1}

Non-acidified formulation

Enfamil™

Human Milk Fortifier
Liquid
High Protein

4 g of protein per 100 Cal when mixed with preterm breast milk at the 24 Cal/fl oz concentration

For premature and low-birth-weight infants fed breast milk

Commercially Sterile, Milk-Based, Ultra-Concentrated Liquid

5.5 fl oz (163 mL)

6-5.5 fl oz (163ml) bottles (Net 33 fl oz •1.03 qt • 976 mL)

Side panel

Use by date on carton and bottle label.

This unit not intended for individual sale.

Warning: Do not use a microwave oven to warm fortified breast milk. Serious burns may result.

Failure to follow these instructions could result in severe harm. Opened bottles and fortified breast milk can spoil quickly.

Follow your hospital's policy on storage of fortified breast milk and tube feedings.

Mead Johnson & Company, LLC Evansville, in 47721 U.S.A.
^©2021 Mead Johnson & Company, LLC

For Canada: 1 800-361-6323
HCP Mead Johnson (U.S product website)

Have questions? We're here for you. Healthcare professionals can contact your local Mead Johnson representative or visit us at HCP Mead Johnson (U.S product website) or call us at 1-800-361-6323.

Instructions for use

Tear Here to Remove Protective Seal Around Cap

Caution: Nutritionally Incomplete: To be used only under the supervision of a physician.

Do not administer directly - must add to breast milk - warning: not for parenteral (i.v.) use.

See carton for complete preparation and use details.

Use as directed by the baby's doctor. Shake gently before using. Do not shake vigorously to minimize product foaming. Foaming is normal with this product. Remove protective seal around cap, remove cap and foil seal. This product is commercially sterile as produced.

Only use in a formulary or centralized milk preparation room where there is little risk of contamination, using proper aseptic technique.^{Footnote 1a} A variety of aseptic preparation methods are available including the use of sterile containers, or sterile transfer lids and sterile, single-use, enteral syringes. When using sterile containers, after opening bottle pour into disposable, sterile container and draw up needed volume into a sterile, single-use, enteral syringe. Dispense into measured breast milk and swirl. For directions using sterile transfer lids and sterile, single-use, enteral syringes, see carton. Either use immediately or replace fortifier bottle cap and store in refrigerator at 35-40°F (2-4°C) for no longer than 48 hours. After 48 hours of opening, discard any unused product. Agitate gently before each use. After feeding begins, use fortified breast milk within one hour or discard. Do not freeze. Add fortifier to breast milk according to the following chart for mixing:

5 mL Fortifier Added To:

50 mL breast milk adds - 2 Cal/fl oz (22 Cal/fl oz concentration)

25 mL breast milk adds - 4 Cal/fl oz (24 Cal/fl oz concentration)

Storage: Store unopened bottles at room temperature. Avoid excessive heat. Do not freeze

Do not use if protective seal around cap, or if foil seal under cap, is damaged or missing.

Use by

2066405

Product information (carton)

Only use in a formulary or centralized milk preparation room where there is little risk of contamination, using proper aseptic technique.1 A variety of aseptic preparation methods are available including the use of sterile containers, or sterile transfer lids and sterile, single-use, enteral syringes.

When using sterile transfer lids and sterile, single-use, enteral syringes:

1. Share gently. Remove protective seal around cap, remove cap, and remove foil seal.
2. Attach transfer lid and sterile, single-use, enteral syringe and draw up prescribed amount of fortifier.
3. Add fortifier volume specified by HCP into breast milk and swirl. Dispose of syringe.

See back of carton for further Instructions for Preparation and Use

Sterile transfer lid and single-use, enteral syringe not included with product. These may be purchased from your preferred vendor or from Mead Johnson.

Enfamil^® is designed for premature Human Milk Fortifier Liquid infants as a nutritional supplement to be added to breast milk.

• Ultra-Concentrated formulation minimizes dilution of breast milk
• Liquid form is commercially sterile and easy to mix
• Convenient 5.5 fl oz bottle is designed for formulary or centralized milk room customized volume fortification and batch mixing, using proper aseptic technique^{Footnote 1b}

Formulated to support the needs of premature and low-birth-weight infants when added to breast milk.

• 4 g protein/100 Cal when mixed with preterm human milk at the 24 Calorie per fluid ounce concentration to promote growth
• DHA and ARA to help promote brain and eye development
• Balance of macronutrients and micronutrients to provide excellent, quality nutrition

Caution: nutritionally incomplete: To be used only under the supervision of a physician.

Do not administer directly - must add to breast milk

Warning: not for parenteral (i.v.) use.

Instructions for Preparation & Use:

A baby's health depends on carefully following the instructions below. Use only as directed by a medical professional. Improper hygiene, preparation, dilution, use or storage may result in severe harm. Follow hospital rules or the baby's doctor's instructions for the safe handling of breast milk. Failure to follow these instructions could result in severe harm. Opened bottles and fortified breast milk can spoil quickly. This product is commercially sterile as produced. Only use in a formulary or centralized milk preparation room where there is little risk of contamination, using proper aseptic technique^{Footnote 1b}. A variety of aseptic preparation methods are available including the use of sterile containers, or sterile transfer lids and sterile, single-use, enteral syringes.

5 mL Fortifier Added To:

50 mL breast milk adds - 2 Cal/fl oz (22 Cal/fl oz concentration)

25 mL breast milk adds - 4 Cal/fl oz - (24 Cal/fl oz concentration)

Shake gently before using. Do not shake vigorously to minimize product foaming. Foaming is normal with this product. When using sterile containers, after opening bottle pour into disposable, sterile container. Draw up needed volume into a sterile, single-use, enteral syringe. Dispense into measured breast milk and swirl. For directions using sterile transfer lids and sterile, single-use, enteral syringes, see side panel. Either use immediately or replace fortifier bottle cap and store in refrigerator at 35-40°F (2-4°C) for no longer than 48 hours. After 48 hours of opening, discard any unused product. Agitate gently before each use. After feeding begins, use fortified breast milk within one hour or discard. Do not freeze. Storage: Store unopened bottles at room temperature. Avoid excessive heat. Do not freeze.

Warning: Do not use a microwave oven to warm the fortified breast milk. Serious burns may result.

Do not use if protective seal around cap, or if foil seal under cap, is damaged or missing. use by date on carton and bottle label.

2066405

Nutritional panel

Ingredients:

Water, Whey Protein Isolate Hydrolysate (Milk), Medium Chain Triglycerides (MCT Oil), Soy Oil, And Less Than 2%: Mortierella Alpina Oil^{Footnote *}, Schizochytrium Sp. Oil^{Footnote †}, Pectin, Vitamin A Palmitate, Vitamin E Acetate, Vitamin D3, Vitamin K1, Thiamin Hydrochloride, Riboflavin, Vitamin B6 Hydrochloride, Vitamin B12, Niacinamide, Folic Acid, Calcium Pantothenate, Biotin, Ascorbic Acid, Calcium Citrate, Calcium Phosphate, Cupric Sulfate, Sodium Citrate, Potassium Citrate, Calcium Chloride, Ferrous Sulfate, Magnesium Phosphate, Zinc Sulfate.

Have questions? We're here for you

Healthcare professionals can contact your local Mead Johnson representative or visit us at HCP Mead Johnson (U.S. product website) or call us at 1-800-361-6323.

For Canada: 1 800-361-6323

Enfamil A+ Canada

Mead Johnson & Company LLC

Evansville, IN 47721 U.S.A

^©2021 Mead Johnson & Company, LLC

Mead Johnson™ Nutrition

Have questions? We're here for you

Healthcare professionals can contact your local Mead Johnson representative or visit us at hcp.meadjohnson.com (U.S. product website) or call us at 1-800-361-6323.

For Canada: 1 800-361-6323

Enfamil.ca