Ammonul (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10% per 10% is supplied in a sterile, non-pyrogenic, single use glass vial.

NDC 0187-0010-50 single use vial containing 50 mL of sodium phenylacetate and sodium benzoate injection 10% per 10%.

Storage: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

17 PATIENT COUNSELING INFORMATION

Physicians should advise patients and caregivers about the following for safe use of AMMONUL:

When plasma ammonia levels have normalized, dietary protein intake can usually be increased with the goal of unrestricted protein intake.
The most common adverse reactions are vomiting, hyperglycemia, hypokalemia, convulsions, and mental impairment.
Generally BUPHENYL is stopped during the time AMMONUL is used.

Distributed by:
Bausch Health US, LLC
Bridgewater, NJ 08807 USA
Manufactured by:
Cangene BioPharma, LLC
Baltimore, MD 21230 USA

AMMONUL is a trademark of Bausch Health Companies Inc. or its affiliates.

© 2020 Bausch Health Companies Inc. or its affiliates

9428204

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 0187-0010-50

Rx only

AMMONUL ®
(sodium phenylacetate and
sodium benzoate) injection

10% / 10%

50 mL For IV Use Only

Warning: Administration must be through a central venous catheter.
Administration through a peripheral line may cause burns.

Must be diluted before IV administration
Sterile, non-pyrogenic, single use vial

carton
(click image for full-size original)
carton
AMMONUL
sodium phenylacetate and sodium benzoate injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-0010
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sodium phenylacetate (phenylacetic acid) sodium phenylacetate 100 mg in 1 mL
sodium benzoate (benzoic acid) sodium benzoate 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water
sodium hydroxide
hydrochloric acid
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-0010-50 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 50 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (0187-0010-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020645 02/17/2005
Labeler — Bausch Health US LLC (831922468)
Establishment
Name Address ID/FEI Operations
Cangene bioPharma LLC 050783398 MANUFACTURE (0187-0010)

Revised: 12/2020 Bausch Health US LLC

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