VENTOLIN HFA (Page 7 of 7)

Principal Display Panel

NDC 68258-3037-1

Ventolin® HFA

(albuterol sulfate)

Inhalation Aerosol

90 mcg per actuation

200 Metered Inhalations

Rx only

FOR ORAL INHALATION ONLY

For use with Ventolin® HFA actuator only.

Discard when the counter reads 000 or 12 months after removal from the moisture-protective foil pouch.

Pouch opened: ____ Use by: ____

Net Wt. 18 g

Contents: A microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). Each actuation delivers 108 mcg of albuterol sulfate equivalent to 90 mcg albuterol base from the mouthpiece. See prescribing information for dosage information.

Important: Read accompanying directions carefully.

WARNING: Do not exceed the dose prescribed by your doctor.

If difficulty in breathing persists, get immediate medical help.

Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Keep out of reach of children. Shake the inhaler well before each spray.

Store and use between 15o and 25o C (59o and 77o F). Store inhaler with mouthpiece down.

label
(click image for full-size original)
VENTOLIN HFA
albuterol sulfate aerosol, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68258-3037(NDC:0173-0682-20)
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
NORFLURANE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68258-3037-1 200 AEROSOL, METERED (INHALATION) in 1 INHALER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020983 07/22/2009
Labeler — Dispensing Solutions Inc. (066070785)
Establishment
Name Address ID/FEI Operations
Dispensing Solutions Inc. 066070785 repack, relabel

Revised: 03/2010 Dispensing Solutions Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.