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  • Manufacturer Name : Covis
  • MFG # : 00310080060
  • NDC : 00310080060
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind NR
DESI2 Drug Ind -
DESI2 Drug Ind NR
Drug Category -
Drug Category S
Drug Category -
Drug Type Code S
Drug Type Code 1
Drug Type Code S
FDA Approval Date 11/29/2012
FDA Approval Date 07/23/2012
FDA Approval Date 11/29/2012
FDA Therap Equiv GM
FDA Therap Equiv NR
FDA Therap Equiv GM
HCPCS -
HCPCS -
HCPCS -
Market Entry Date -
Market Entry Date 11/29/2012
Market Entry Date -
Medical Coverage -
Medical Coverage -
Medical Coverage -
Termination Date 1
Termination Date -
Termination Date 1
Unit -
Unit GM
Unit -
Units Per Pkg 07/23/2012
Units Per Pkg -
Units Per Pkg 07/23/2012
Active Ingredients 14614 aclidinium bromide 320345991
Active Ingredients 14614 aclidinium bromide 320345991
Active Ingredients 14614 aclidinium bromide 320345991
AHFS Class 12080800 ANTIMUSCARINICS/ANTISPASMODICS; 48120800 ANTICHOLINERGIC AGENTS (RESPIR.TRACT)
AHFS Class 12080800 ANTIMUSCARINICS/ANTISPASMODICS; 48120800 ANTICHOLINERGIC AGENTS (RESPIR.TRACT)
AHFS Class 12080800 ANTIMUSCARINICS/ANTISPASMODICS; 48120800 ANTICHOLINERGIC AGENTS (RESPIR.TRACT)
DEA Class NC
DEA Class NC
DEA Class NC
Dose Form AEROSOL POWDER, BREATH ACTIVATED (EA)
Dose Form AEROSOL POWDER, BREATH ACTIVATED (EA)
Dose Form AEROSOL POWDER, BREATH ACTIVATED (EA)
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 69855 aclidinium bromide INHALATION AER POW BA 400 MCG
Gen Code and Des 69855 aclidinium bromide INHALATION AER POW BA 400 MCG
Gen Code and Des 69855 aclidinium bromide INHALATION AER POW BA 400 MCG
Inactive Ingredients 2432 lactose 64044515
Inactive Ingredients 2432 lactose 64044515
Inactive Ingredients 2432 lactose 64044515
OMP Family -
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 400MCG
Strength 400MCG
Strength 400MCG
Common Brand Name COMMON BRAND NAME(S): Tudorza
Common Brand Name COMMON BRAND NAME(S): Tudorza
Common Brand Name COMMON BRAND NAME(S): Tudorza
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Allocation Period -
Allocation Period -
Allocation Period -
Case Quantity 48
Case Quantity 48
Case Quantity 48
Drug Form Pack Size 60
Drug Form Pack Size 60
Drug Form Pack Size 60
Form INHALANT
Form INHALANT
Form INHALANT
Hazard Code -
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
NIOSH Code -
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Retail Pack Quantity 1
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit EA
Unit Size 60
Unit Size 60
Unit Size 60
How to Use HOW TO USE: Read the Patient Information Leaflet and instruction sheet if available from your pharmacist before you start using aclidinium and each time you get a refill. Learn how to use this inhaler properly. If you have any questions, ask your doctor or pharmacist. Inhale this medication by mouth as directed by your doctor, usually twice daily (every 12 hours). Do not breathe out into the mouthpiece at any time. Avoid getting this medication into your eyes. It may cause eye irritation and temporary blurred vision. If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication. Use this medication regularly to get the most benefit from it. This medication works best if used at evenly spaced intervals. To help you remember, use it at the same times each day. Do not increase your dose, use this medication more often, or stop using it without first consulting your doctor. Learn which of your inhalers you should use every day and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, waking up at night with trouble breathing, if you use your quick-relief inhaler more often, or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away. Tell your doctor if your symptoms do not improve or if they worsen.
How to Use HOW TO USE: Read the Patient Information Leaflet and instruction sheet if available from your pharmacist before you start using aclidinium and each time you get a refill. Learn how to use this inhaler properly. If you have any questions, ask your doctor or pharmacist. Inhale this medication by mouth as directed by your doctor, usually twice daily (every 12 hours). Do not breathe out into the mouthpiece at any time. Avoid getting this medication into your eyes. It may cause eye irritation and temporary blurred vision. If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication. Use this medication regularly to get the most benefit from it. This medication works best if used at evenly spaced intervals. To help you remember, use it at the same times each day. Do not increase your dose, use this medication more often, or stop using it without first consulting your doctor. Learn which of your inhalers you should use every day and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, waking up at night with trouble breathing, if you use your quick-relief inhaler more often, or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away. Tell your doctor if your symptoms do not improve or if they worsen.
How to Use HOW TO USE: Read the Patient Information Leaflet and instruction sheet if available from your pharmacist before you start using aclidinium and each time you get a refill. Learn how to use this inhaler properly. If you have any questions, ask your doctor or pharmacist. Inhale this medication by mouth as directed by your doctor, usually twice daily (every 12 hours). Do not breathe out into the mouthpiece at any time. Avoid getting this medication into your eyes. It may cause eye irritation and temporary blurred vision. If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication. Use this medication regularly to get the most benefit from it. This medication works best if used at evenly spaced intervals. To help you remember, use it at the same times each day. Do not increase your dose, use this medication more often, or stop using it without first consulting your doctor. Learn which of your inhalers you should use every day and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, waking up at night with trouble breathing, if you use your quick-relief inhaler more often, or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away. Tell your doctor if your symptoms do not improve or if they worsen.
Missed Dose MISSED DOSE: If you miss a dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Missed Dose MISSED DOSE: If you miss a dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Missed Dose MISSED DOSE: If you miss a dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others.
Notes NOTES: Do not share this medication with others.
Notes NOTES: Do not share this medication with others.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Phonetic Pronunciation (A-kli-DIN-ee-um)
Phonetic Pronunciation (A-kli-DIN-ee-um)
Phonetic Pronunciation (A-kli-DIN-ee-um)
Precautions PRECAUTIONS: Before using aclidinium, tell your doctor or pharmacist if you are allergic to it; or to atropine or other belladonna-type drugs; or if you have any other allergies. This product may contain inactive ingredients (such as milk proteins), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of glaucoma (angle-closure type), difficulty urinating (for example, due to enlarged prostate). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before using aclidinium, tell your doctor or pharmacist if you are allergic to it; or to atropine or other belladonna-type drugs; or if you have any other allergies. This product may contain inactive ingredients (such as milk proteins), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of glaucoma (angle-closure type), difficulty urinating (for example, due to enlarged prostate). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before using aclidinium, tell your doctor or pharmacist if you are allergic to it; or to atropine or other belladonna-type drugs; or if you have any other allergies. This product may contain inactive ingredients (such as milk proteins), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of glaucoma (angle-closure type), difficulty urinating (for example, due to enlarged prostate). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Rarely, this medication may cause severe sudden worsening of breathing problems right after use. If you have sudden worsening of breathing, use your quick-relief inhaler and get medical help right away. Tell your doctor right away if you have any serious side effects, including: difficult/painful urination. Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night, blurred vision). A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects SIDE EFFECTS: Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Rarely, this medication may cause severe sudden worsening of breathing problems right after use. If you have sudden worsening of breathing, use your quick-relief inhaler and get medical help right away. Tell your doctor right away if you have any serious side effects, including: difficult/painful urination. Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night, blurred vision). A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects SIDE EFFECTS: Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Rarely, this medication may cause severe sudden worsening of breathing problems right after use. If you have sudden worsening of breathing, use your quick-relief inhaler and get medical help right away. Tell your doctor right away if you have any serious side effects, including: difficult/painful urination. Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night, blurred vision). A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store at room temperature away from moisture. Do not store in the bathroom. Keep new inhalers in the sealed pouch until you are ready to use them. The inhaler should be discarded when the dose indicator shows "0", when the inhaler becomes locked, or 45 days after removing the inhaler from the sealed pouch, whichever comes first. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Storage STORAGE: Store at room temperature away from moisture. Do not store in the bathroom. Keep new inhalers in the sealed pouch until you are ready to use them. The inhaler should be discarded when the dose indicator shows "0", when the inhaler becomes locked, or 45 days after removing the inhaler from the sealed pouch, whichever comes first. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Storage STORAGE: Store at room temperature away from moisture. Do not store in the bathroom. Keep new inhalers in the sealed pouch until you are ready to use them. The inhaler should be discarded when the dose indicator shows "0", when the inhaler becomes locked, or 45 days after removing the inhaler from the sealed pouch, whichever comes first. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: Aclidinium is used to control and prevent symptoms (such as wheezing, shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Aclidinium belongs to a class of drugs known as anticholinergics. Controlling symptoms of breathing problems can decrease time lost from work or school. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden breathing problems. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.
Uses USES: Aclidinium is used to control and prevent symptoms (such as wheezing, shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Aclidinium belongs to a class of drugs known as anticholinergics. Controlling symptoms of breathing problems can decrease time lost from work or school. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden breathing problems. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.
Uses USES: Aclidinium is used to control and prevent symptoms (such as wheezing, shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Aclidinium belongs to a class of drugs known as anticholinergics. Controlling symptoms of breathing problems can decrease time lost from work or school. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden breathing problems. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

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