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ACETADOTE- acetylcysteine injection, solution


  1. Patient Information
  2. Revised: 4/2019document Id:

Patient Information 

Hypersensitivity Reactions

Advise patients and caregivers that hypersensitivity reactions related to administration and infusion may occur during and after ACETADOTE treatment, including hypotension, wheezing, shortness of breath and bronchospasm[see Warnings and Precautions (5.1)].

For specific treatment information regarding the clinical management of acetaminophen overdose, please contact your regional poison center at 1-800-222-1222, or alternatively, a special health professional assistance line for acetaminophen overdose at 1-800-525-6115.

Manufactured for:
Cumberland Pharmaceuticals Inc.
Nashville, TN 37203

U.S. Patent Nos. 8,148,356, 8,399,445, 8,653,061 8,722,738 and 9,327,028

PRINCIPAL DISPLAY PANEL Vial Label

30 mL NDC 66220-207-30
Sterile

Acetadote
(acetylcysteine) Injection

6 g/30 mL
(200 mg/mL)

MUST BE FURTHER DILUTED
PRIOR TO INTRAVENOUS USE

(01)00366220207309

PRINCIPAL DISPLAY PANEL     Vial Label

PRINCIPAL DISPLAY PANEL Carton Label

4 30mL Sterile Vials NDC 66220-207-30

Acetadote
(acetylcysteine) Injection

6 g/30 mL
(200 mg/mL)

MUST BE FURTHER DILUTED
PRIOR TO INTRAVENOUS USE

CUMBERLAND
PHARMACEUTICALS

Manufactured for:
Cumberland Pharmaceuticals Inc.
Nashville, TN, USA, 37203

Made in USA

PRINCIPAL DISPLAY PANEL     Carton Label
ACETADOTE
acetylcysteine injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66220-207
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetylcysteine(UNII: WYQ7N0BPYC) (Acetylcysteine - UNII:WYQ7N0BPYC)Acetylcysteine200 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
water(UNII: 059QF0KO0R)
sodium hydroxide(UNII: 55X04QC32I)
nitrogen(UNII: N762921K75)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66220-207-304 in 1 CARTON01/23/2004
130 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02153901/23/2004
Labeler -Cumberland Pharmaceuticals Inc. (069532880)

Revised: 4/2019document Id: 

7941a49e-3328-4cc0-b960-2c8556ac771dSet id: 472f158a-5ab9-4308-8e49-1116e6ea3d39Version: 9Effective Time: 20190403Cumberland Pharmaceuticals Inc.



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