Proventil HFA: Package Insert and Label Information (Page 3 of 3)

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Proventil HFA 90mcg
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PROVENTIL HFA albuterol sulfate aerosol, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-004(NDC:0085-1132)
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Albuterol Sulfate (Albuterol) Albuterol Sulfate 108 ug
Inactive Ingredients
Ingredient Name Strength
alcohol
Norflurane
Oleic acid
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42254-004-67 1 CANISTER (CANISTER) in 1 CARTON contains a CANISTER
1 200 AEROSOL, METERED (INHALATION) in 1 CANISTER This package is contained within the CARTON (42254-004-67)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020503 10/01/2001
Labeler — Rebel Distributors Corp. (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp. 118802834 RELABEL, REPACK

Revised: 10/2011 Rebel Distributors Corp.

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