Acetylcysteine (Page 4 of 4)

HOW SUPPLIED

Acetylcysteine Solution, USP is supplied in teartop vials as follows:

Unit of Sale	Concentration
NDC 0409-3307-03 Carton containing 3 teartop vials	10%3 g/30 mL (100 mg/mL)
NDC 0409-3308-03 Carton containing 3 teartop vials	20%6 g/30 mL (200 mg/mL)

The 20% solution may be diluted to a lesser concentration with either Sodium Chloride for Injection, Sodium Chloride for Inhalation, Sterile Water for Injection, or Sterile Water for Inhalation. The 10% solution may be used undiluted.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Store in refrigerator 2° to 8°C (36° to 46°F) after opening. Discard opened vial after 96 hours.

Acetylcysteine solution does not contain an antimicrobial agent, and care must be taken to minimize contamination of the sterile solution. Dilutions of acetylcysteine should be used freshly prepared and utilized within one hour. If only a portion of the solution in a vial is used, store the remaining undiluted portion in a refrigerator and use within 96 hours.

A change in color may occur after opening; this does not change the efficacy of the drug.

REFERENCES

1.

Bonanomi L, Gazzaniga A. Toxicological, pharmacokinetic and metabolic studies on acetylcysteine. Eur J Respir Dis 1981 ; 61(suppl 111):45−51.

2.

Am Rev Respir Dis 1960 ; 82:627−639.

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1286-2.0

Revised: 09/2018

PRINCIPAL DISPLAY PANEL — 30 mL Vial Label — 10%

30 mL
NOT FOR INJECTION

10%
ACETYLCYSTEINE
Solution, USP

For Inhalation (Mucolytic Agent) or
Oral Administration
(Acetaminophen Antidote).

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

LOT ##-###-AAEXP DMMMYYYY

PRINCIPAL DISPLAY PANEL — 30 mL Vial Carton — 10%

30 mL

Rx only
NDC 0409-3307-03
Contains 3 of NDC 0409-3307-11

10%
ACETYLCYSTEINE
Solution, USP

For Inhalation (Mucolytic Agent)
or Oral Administration
(Acetaminophen Antidote).

NOT FOR INJECTION.

MADE IN JAPAN Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

PRINCIPAL DISPLAY PANEL — 30 mL Vial Label — 20%

30 mL
NOT FOR INJECTION

20%
ACETYLCYSTEINE
Solution, USP

For Inhalation (Mucolytic Agent) or Oral
Administration (Acetaminophen Antidote). May
be diluted to a lesser concentration with an
appropriate solution.

Distributed by
Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

LOT ##-###-AAEXP DMMMYYYY

PRINCIPAL DISPLAY PANEL — 30 mL Vial Carton — 20%

30 mL

Rx only
NDC 0409-3308-03
Contains 3 of NDC 0409-3308-11

20%
Acetylcysteine
Solution, USP

For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote). NOT FOR INJECTION.

Hospira

ACETYLCYSTEINE acetylcysteine solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-3307 Route of Administration ORAL, RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETYLCYSTEINE (ACETYLCYSTEINE) ACETYLCYSTEINE 100 mg in 1 mL

Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM 0.25 mg in 1 mL SODIUM HYDROXIDE HYDROCHLORIC ACID

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0409-3307-03 3 VIAL in 1 CARTON contains a VIAL (0409-3307-11) 1 NDC:0409-3307-11 30 mL in 1 VIAL This package is contained within the CARTON (0409-3307-03)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA073664 04/30/2005

ACETYLCYSTEINE acetylcysteine solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-3308 Route of Administration ORAL, RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETYLCYSTEINE (ACETYLCYSTEINE) ACETYLCYSTEINE 200 mg in 1 mL

Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM 0.5 mg in 1 mL SODIUM HYDROXIDE HYDROCHLORIC ACID

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0409-3308-03 3 VIAL in 1 CARTON contains a VIAL (0409-3308-11) 1 NDC:0409-3308-11 30 mL in 1 VIAL This package is contained within the CARTON (0409-3308-03)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074037 06/01/2005

Labeler — Hospira, Inc. (141588017)

Establishment
Name	Address	ID/FEI	Operations
Hospira, Inc.		093132819	ANALYSIS (0409-3307), ANALYSIS (0409-3308), LABEL (0409-3307), LABEL (0409-3308), MANUFACTURE (0409-3307), MANUFACTURE (0409-3308), PACK (0409-3307), PACK (0409-3308)

Establishment
Name	Address	ID/FEI	Operations
Hospira, Inc.		827731089	ANALYSIS (0409-3307), ANALYSIS (0409-3308)

Revised: 08/2020 Hospira, Inc.