acetylcysteine solution, USP How Supplied/Storage and Handling

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HOW SUPPLIED

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

Unit of SaleConcentration
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.

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How Supplied/Storage and Handling

HOW SUPPLIED

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

Unit of SaleConcentration
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.

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