Acetaminophen (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 500 mg/50 mL Carton Label

One 50 mL fill PAB® Container

Acetaminophen Injection

500 mg/50 mL (10 mg/mL)

NDC 0264-4050-80

REF DA4050

For Intravenous Use Only

Protect from light until use.

CAUTION: DO NOT ADD SUPPLEMENTARY MEDICATION.

Each 50 mL contains 500 mg Acetaminophen, USP,
1,900 mg Mannitol, USP, 15 mg Sodium Citrate Dihydrate, USP,
and Water for Injection, USP qs.

pH is adjusted with glacial acetic acid.

Single Dose Container. Doses less than 500 mg require aseptic transfer
to a separate container prior to dispensing. Discard unused portion.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]
Do not freeze. Do not expose the product under light.

See Package Insert for recommended dosage and
Full Prescribing Information.

Not made with natural rubber latex, PVC or DEHP.

PAB is a registered trademark of B. Braun Medical Inc.

Rx only

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862Prepared in USA. API from USA or China.

X12-002-504 LD-553-4

LOT

EXP

PRINCIPAL DISPLAY PANEL — 1,000 mg/100 mL Container Label

Acetaminophen Injection

1,000 mg/100 mL

(10 mg/mL)

REF DA4100

NDC 0264-4100-90

100 mL fill

PAB® Container

For Intravenous Use Only

Protect from light until use.

CAUTION: DO NOT ADD SUPPLEMENTARY MEDICATION.

Single Dose Container. Doses less than 1,000 mg require
aseptic transfer to a separate container prior to dispensing.
Discard unused portion.

Each 100 mL contains 1,000 mg Acetaminophen, USP, 3,800 mg
Mannitol, USP, 30 mg Sodium Citrate Dihydrate, USP, and Water
for Injection, USP qs.

pH is adjusted with glacial acetic acid.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F). [See USP Controlled Room
Temperature.] Do not freeze. Do not expose the product
under light.

See Package Insert for recommended dosage and Full
Prescribing Information.

Not made with natural rubber latex, PVC or DEHP.

PAB is a registered trademark of B. Braun Medical Inc.

Rx only

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862
Prepared in USA.API from USA or China.

Y94-003-437 LD-550-3

LOT

EXP

PRINCIPAL DISPLAY PANEL — 1,000 mg/100 mL Carton Label

One 100 mL fill PAB® Container

Acetaminophen Injection

1,000 mg/100 mL (10 mg/mL)

NDC 0264-4100-90

REF DA4100

For Intravenous Use Only

Protect from light until use.

CAUTION: DO NOT ADD SUPPLEMENTARY MEDICATION.

Each 100 mL contains 1,000 mg Acetaminophen, USP,
3,800 mg Mannitol, USP, 30 mg Sodium Citrate Dihydrate,
USP, and Water for Injection, USP qs.

pH is adjusted with glacial acetic acid.

Single Dose Container. Doses less than 1,000 mg require
aseptic transfer to a separate container prior to dispensing.
Discard unused portion.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F). [See USP Controlled
Room Temperature.] Do not freeze. Do not expose the
product under light.

See Package Insert for recommended dosage and
Full Prescribing Information.

Not made with natural rubber latex, PVC or DEHP.

PAB is a registered trademark of B. Braun Medical Inc.

Rx only

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862Prepared in USA. API from USA or China.

X12-002-505 LD-554-5

LOT

EXP

ACETAMINOPHEN acetaminophen injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0264-4050 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 10 mg in 1 mL

Inactive Ingredients Ingredient Name Strength MANNITOL 38 mg in 1 mL SODIUM CITRATE 0.3 mg in 1 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0264-4050-80 24 CONTAINER in 1 CASE contains a CONTAINER 1 50 mL in 1 CONTAINER This package is contained within the CASE (0264-4050-80)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA204957 02/18/2021

ACETAMINOPHEN acetaminophen injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0264-4100 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 10 mg in 1 mL

Inactive Ingredients Ingredient Name Strength MANNITOL 38 mg in 1 mL SODIUM CITRATE 0.3 mg in 1 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0264-4100-90 24 CONTAINER in 1 CASE contains a CONTAINER 1 100 mL in 1 CONTAINER This package is contained within the CASE (0264-4100-90)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA204957 02/18/2021

Labeler — B. Braun Medical Inc. (002397347)

Revised: 01/2022 B. Braun Medical Inc.