Acetylcysteine (Page 5 of 5)

Estimating Potential for Hepatotoxicity:

The following nomogram has been developed to estimate the probability that plasma levels in relation to intervals post-ingestion will result in hepatotoxicity.

Nomogram -- estimating potential for hepatotoxicity
(click image for full-size original)

HOW SUPPLIED

Acetylcysteine Solution, USP, is available in rubber stopped glass vials containing 10 or 30 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.

Acetycysteine is sterile, not for injection and can be used for inhalation (mucolytic agent) or oral administration (acetaminophen antidote). It is available as follows:

20% Acetylcysteine Solution, USP (200 mg acetylcysteine per mL).

NDC 54868-5670-0 1 x 30 mL vial

Store unopened vials at controlled room temperature, 15° to 30°C (59° to 86°F).

Acetylcysteine Solution, USP 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.

REFERENCES

  1. Bonanomi L, Gazzaniga A. Toxicological pharmacokinetic and metabolic studies on acetylcysteine. Eur J Respir Dis 1981 61 (Suppl III):45–51.
  2. Amer Rev Resp Dis 1960 82 :627–639.

Mfd. by Ben Venue Laboratories, Inc., Bedford, Ohio 44146

RXAC-P01

Revised March 2007
© RLI, 2007

Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

VIAL LABEL 20%, 30 mL

Vial label for Acetylcysteine Solution, USP 20%, 30 mL
(click image for full-size original)

Vial Label 20%, 30 mL

ACETYLCYSTEINE acetylcysteine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5670(NDC:0054-3026)
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
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5670-0 1 VIAL (VIAL) in 1 BOTTLE, DISPENSING contains a VIAL
1 30 mL in 1 VIAL This package is contained within the BOTTLE, DISPENSING (54868-5670-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072324 06/29/2009
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel (54868-5670)

Revised: 09/2012 Physicians Total Care, Inc.

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