QVAR (Page 4 of 4)

HOW SUPPLIED

QVAR is supplied in two strengths:

QVAR 40 mcg is supplied in a 7.3 g canister containing 100 actuations with a beige plastic actuator and gray dust cap, and Patient’s Instructions; box of one;
100 Actuations – NDC 54868-5857-0

or in an 8.7 g canister containing 120 actuations with a beige plastic actuator and gray dust cap, and Patient’s Instructions; box of one;
120 Actuations — NDC 54868-5857-1

QVAR 80 mcg is supplied in a 7.3 g canister containing 100 actuations with a dark mauve plastic actuator and gray dust cap, and Patient’s Instructions; box of one;
100 Actuations – NDC 54868-5858-0

or in an 8.7 g canister containing 120 actuations with a dark mauve plastic actuator and gray dust cap, and Patient’s Instructions; box of one;
120 Actuations — NDC 54868-5858-1

The correct amount of medication in each inhalation cannot be assured after 100 actuations from the 7.3 g canister or 120 actuations from the 8.7 g canister even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.

Store QVAR Inhalation Aerosol when not being used, so that the product rests on the concave end of the canister with the plastic actuator on top.

Store at 25°C (77°F).

Excursions between 15° and 30°C (59° and 86°F) are permitted (see USP). For optimal results, the canister should be at room temperature when used. QVAR Inhalation Aerosol canister should only be used with the QVAR Inhalation Aerosol actuator and the actuator should not be used with any other inhalation drug product.

CONTENTS UNDER PRESSURE

Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw container into fire or incinerator.

Keep out of reach of children.

Rx only

U.S. Patent Nos. 5605674, 5683677, 5695743, 5776432

Mktd by:Teva Respiratory, LLC– Horsham, PA 19044

Developed and Manufactured by:3M Drug Delivery SystemNorthridge, CA 91324OR 3M Health Care, Ltd.Loughborough, UK

© 2010 Teva Respiratory, LLC
639300
QVAR® is a registered trademark of IVAX LLC, a member of the TEVA Group.
Rev. 09/10

OptiChamber is a registered trademark of Respironics Healthscan, Inc. and AeroChamber Plus is a registered trademark of Trudell Medical International Trudell Partnership Holdings Limited and Packard Medical Supply Centre Ltd.

Relabeling of “Additional” barcode label by:
Physicians Total Care, Inc.
Tulsa, OK 74146

PATIENT’S INSTRUCTIONS

QVAR®
(beclomethasone dipropionate HFA)
INHALATION AEROSOL

Attention Pharmacist: Detach “Patient’s Instructions for Use” from package insert and dispense with the product.

PATIENT’S INSTRUCTIONS

It is important that you read these instructions before using QVAR.

Correct and regular use of the inhaler will prevent or lessen the severity of asthma attacks.

1. Remove the plastic cap (see Figure 1) and be sure there are no foreign objects in the mouthpiece.

Figure 1

image of Figure 1.Remove the plastic cap

2. As with all aerosol medications, it is recommended to prime the QVAR inhaler before using for the very first time after purchase, and in cases where the inhaler has not been used for more than ten days. Prime by releasing two actuations into the air, away from your eyes and face. Be sure the canister is firmly seated in the plastic mouthpiece adapter before each use.

3. BREATHE OUT AS FULLY AS YOU COMFORTABLY CAN. Hold the inhaler as shown in Figure 2. Close your lips around the mouthpiece, keeping your tongue below it.

Figure 2

image of Figure 2.Hold the inhaler as shown

4. WHILE BREATHING IN DEEPLY AND SLOWLY, PRESS DOWN ON THE CAN WITH YOUR FINGER. When you have finished breathing in, hold your breath as long as you comfortably can (i.e., 5 — 10 seconds).

5. TAKE YOUR FINGER OFF THE CAN and remove the inhaler from your mouth. Breathe out gently.

6. If your physician has told you to take more than one inhalation per treatment repeat steps 3 through 5.

7. You should rinse your mouth with water after treatment.

8. For normal hygiene, the mouthpiece of your inhaler should be cleaned weekly with a clean, dry tissue or cloth.

DO NOT WASH OR PUT ANY PART OF YOUR INHALER IN WATER.

9. DISCARD THE CANISTER AFTER the date calculated by your physician or pharmacist. The correct amount of medication in each inhalation cannot be assured after 100 actuations from the 7.3 g canister even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used. Before the discard date you should consult your physician to determine whether a refill is needed. It is advisable to keep track of the number of doses taken from the canister to better predict when a refill is necessary. Just as you should not take extra doses without consulting your physician, you also should not stop taking QVAR without consulting your physician.

IMPORTANT QVAR is preventive therapy for asthma and must be used regularly and at the times your physician has prescribed.

DO NOT CONFUSE QVAR WITH OTHER ASTHMA MEDICATION. QVAR WILL NOT PROVIDE IMMEDIATE RELIEF IF YOU ARE HAVING AN ASTHMA ATTACK.

Your physician will decide whether other medication is needed should you require immediate relief. If you also use another medicine by inhalation, you should consult your physician for instructions on when to use it in relation to using QVAR. If this is the first time you will be using QVAR, it may take from 1 to 4 weeks before you feel the full benefits.

QVAR Inhalation Aerosol canister should only be used with the QVAR Inhalation Aerosol mouthpiece and the mouthpiece should not be used with any other inhalation drug product.

DOSAGE

Use only as directed by your physician.

CONTENTS UNDER PRESSURE

Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw container into fire or incinerator.

Keep out of reach of children.

Avoid spraying in eyes.

Store at 25°C (77°F). For optimal results, the canister should be at room temperature when used. Store QVAR Inhalation Aerosol when not being used, so that the product rests on the concave end of the canister with the plastic actuator on top.

Mktd by:
Teva Specialty Pharmaceuticals LLC
Horsham, PA 19044

Developed and Manufactured by:

3M Drug Delivery Systems
Northridge, CA 91324

or

3M Health Care, Ltd
Loughborough, UK

© 2008 Teva Specialty Pharmaceuticals LLC
QVAR® is a registered trademark of the IVAX Corporation, a member of the TEVA Group.

634600
Rev. 08/08

PRINCIPAL DISPLAY PANEL

QVAR® 40mcg

(beclomethasone
dipropionate HFA, 40 mcg)
INHALATION AEROSOL

For oral inhalation with
QVAR® Actuator only

100
Metered Inhalations
7.3g Net Contents

CFC FREE

image of QVAR package label for 40 mcg

QVAR®
80mcg

(beclomethasone
dipropionate HFA, 80 mcg)
INHALATION AEROSOL

For oral inhalation with
QVAR® Actuator only

100
Metered Inhalations7.3g Net Contents

CFC FREE

image of QVAR package label for 80 mcg image of QVAR package label for 40 mcg image of QVAR package label for 80 mcg
QVAR beclomethasone dipropionate aerosol, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5857(NDC:59310-175)
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BECLOMETHASONE DIPROPIONATE (BECLOMETHASONE 17-MONOPROPIONATE) BECLOMETHASONE DIPROPIONATE 40 ug
Inactive Ingredients
Ingredient Name Strength
NORFLURANE
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5857-0 1 CANISTER (CANISTER) in 1 BOX contains a CANISTER
1 100 AEROSOL, METERED (INHALATION) in 1 CANISTER This package is contained within the BOX (54868-5857-0)
2 NDC:54868-5857-1 1 CANISTER (CANISTER) in 1 BOX contains a CANISTER
2 120 AEROSOL, METERED (INHALATION) in 1 CANISTER This package is contained within the BOX (54868-5857-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020911 01/29/2008
QVAR beclomethasone dipropionate aerosol, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5858(NDC:59310-177)
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BECLOMETHASONE DIPROPIONATE (BECLOMETHASONE 17-MONOPROPIONATE) BECLOMETHASONE DIPROPIONATE 80 ug
Inactive Ingredients
Ingredient Name Strength
NORFLURANE
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5858-0 1 INHALER (CANISTER) in 1 BOX contains a INHALER
1 100 AEROSOL, METERED (INHALATION) in 1 INHALER This package is contained within the BOX (54868-5858-0)
2 NDC:54868-5858-1 1 INHALER (CANISTER) in 1 BOX contains a INHALER
2 120 AEROSOL, METERED (INHALATION) in 1 INHALER This package is contained within the BOX (54868-5858-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020911 01/29/2008
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 01/2010 Physicians Total Care, Inc.

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